Catalog Elitech 2 PDF

DIAGNOSTIC
REAGENTS
Version : CAN-011 March 2005
SEPPIM S.A
ZONE INDUSTRIELLE
61500 SEES FRANCE
: + 33 (0)2 33 81 21 00 ¬ : + 33 (0)2 33 28 77 81
CLINICAL
CHEMISTRY
REAGENTS
Pages
A Pages GLUCOSE PAP SL . . . . . . . . . . . . . . . . . GPSL-4 . . . . . 57-58
Update ACID PHOSPHATASE . . . . . . . . . . . . . . . PACI-4 . . . . . 11-12 GLUCOSE PAP . . . . . . . . . . . . . . . . . . . . GLUP-3 . . . . . . . 59
Update ALBUMIN . . . . . . . . . . . . . . . . . . . . . . . . ALBU-4 . . . . . 13-14

Update ALT/GPT 4+1 SL . . . . . . . . . . . . . . . . ALSL 4/1-3 . . . . . . 15-16 H
HBDH SL . . . . . . . . . . . . . . . . . . . . . . . . . HBSL-3 . . . . . . . 60
ALT/GPT . . . . . . . . . . . . . . . . . . . . . . . . . ALAT-3 . . . . . . . . 17
Update HEMOGLOBIN . . . . . . . . . . . . . . . . . . . . HEMO-2 . . . . . . . 61
AMYLASE SL . . . . . . . . . . . . . . . . . . . . . AMSL-2 . . . . . . . . 18
AMYLASE . . . . . . . . . . . . . . . . . . . . . . . AMYL-4 . . . . . . . . 19 I
Update AST/GOT 4+1 SL. . . . . . . . . . . . . . . . ASSL 4/1-3 . . . . . 20-21 IRON CHROMAZUROL . . . . . . . . . . . . . FECA-3 . . . . . . . 62
AST/GOT . . . . . . . . . . . . . . . . . . . . . . . . . ASAT-3 . . . . . . . . 22 IRON FERROZINE® . . . . . . . . . . . . . . . . FEFR-3 . . . . . 63-64
IRON TIBC . . . . . . . . . . . . . . . . . . . . . . . . TIBC-3 . . . . . . . 65
B L
LACTATE . . . . . . . . . . . . . . . . . . . . . . . . . LACT-2 . . . . . 66-67
BILIRUBIN TOTAL & DIRECT . . . . . . . . . BILI-2 . . . . . 23-24 Update LDH-P 4+1 SL . . . . . . . . . . . . . . . . . . . LDSL 4/1-3 . . . . . 68-69
LDH-P . . . . . . . . . . . . . . . . . . . . . . . . . . . LDHP-3 . . . . . . . 70
C
CALCIUM ARSENAZO . . . . . . . . . . . . . . CALA-3 . . . . . . . . 25 M
CALCIUM OCPC . . . . . . . . . . . . . . . . . . CALO-2 . . . . . 26-27 MAGNESIUM CALMAGITE . . . . . . . . . MAGN-3 . . . . . . . 71
CHLORIDE . . . . . . . . . . . . . . . . . . . . . . CHLO-2 . . . . . . . . 28 MAGNESIUM RBCs . . . . . . . . . . . . . . . . MGER-2 . . . . . . . 72
MICROPROTEIN . . . . . . . . . . . . . . . . . . . PRTP-4 . . . . . 73-74
Update CHOLESTEROL SL . . . . . . . . . . . . . . . . CHSL-6 . . . . . 29-30
CHOLESTEROL . . . . . . . . . . . . . . . . . . CHOL-2 . . . . . . . . 31
Update CHOLESTEROL LDL DIRECT SL . . . . . LDLD-3 . . . . . 32-33
P
PAL (DEA) SL . . . . . . . . . . . . . . . . . . . . . . PASL-3 . . . . . 75-76
Update CHOLESTEROL HDL DIRECT SL . . . . . HDLD-3 . . . . . 34-35 PAL (DEA) . . . . . . . . . . . . . . . . . . . . . . . . PALC-3 . . . . . . . 77
HDL CHOLESTEROL . . . . . . . . . . . . . . . HDLC-3 . . . . . . . . 36 PHOSPHORUS . . . . . . . . . . . . . . . . . . . PHOS-6 . . . . . 78-79
CHOLINESTERASE . . . . . . . . . . . . . . . CHES-3 . . . . . 37-38
CK NAC SL . . . . . . . . . . . . . . . . . . . . . . CKSL-3 . . . . . 39-40
T
TOTAL PROTEIN . . . . . . . . . . . . . . . . . . PRTB-3 . . . . . 80-81
CK NAC . . . . . . . . . . . . . . . . . . . . . . . . . CKNA-3 . . . . . . . . 41 Update TRIGLYCERIDES MONO SL NEW . . . . TGMLN-8 . . . . . 82-83
CK-MB SL. . . . . . . . . . . . . . . . . . . . . . . . CMSL-2 . . . . . 42-43 TRIGLYCERIDES . . . . . . . . . . . . . . . . . . TRIG-2 . . . . . 84-85
CK-MB . . . . . . . . . . . . . . . . . . . . . . . . . . CKMB-3 . . . . . 44-45

COPPER . . . . . . . . . . . . . . . . . . . . . . . . . CUIV-2 . . . . . 46-47 U
CREATININE JAFFE . . . . . . . . . . . . . . . CRCO-6 . . . . . 48-49 UREA COLOR . . . . . . . . . . . . . . . . . . . . . URCO-2 . . . . . 86-87
Update UREA UV SL . . . . . . . . . . . . . . . . . . . . . URSL-5 . . . . . 88-89
Update CREATININE PAP SL . . . . . . . . . . . . . . . CRSL-4 . . . . . 50-51 UREA UV . . . . . . . . . . . . . . . . . . . . . . . . URUV-2 . . . . . . . 90
Update URIC ACID MONO SL . . . . . . . . . . . . . . . AUML-4 . . . . . 91-92
G Update URIC ACID SL . . . . . . . . . . . . . . . . . . . . . AUSL-3 . . . . . 93-94
URIC ACID . . . . . . . . . . . . . . . . . . . . . . . ACUR-2 . . . . . . . 95
GAMMA GT SL . . . . . . . . . . . . . . . . . . . . GASL-3 . . . . . 52-53
GAMMA GT . . . . . . . . . . . . . . . . . . . . . . GAGT-2 . . . . . . . . 54 Z
GLUCOSE HK SL . . . . . . . . . . . . . . . . . GHSL-3 . . . . . 55-56 ZINC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ZINC-2 . . . . . . . 96
Pages
CONTROLS AND CALIBRATORS

BILICAL. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . BIEN-3 . . . . . . . . . . . . 98
CHOLESTEROL LDL CALIBRATOR . . . . . . . . . . . . . . . . . . LDLD-1 . . . . . . . . . . . . . 99
CK - MB CONTROL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . CKMB-3 . . . . . . . . . . . . . 100
ELICAL 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . CALI2-2 . . . . . . . . . . . . . 101
ELITROL I & II . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . CONT-3 . . . . . . . . . . . . . 102
CHOLESTEROL HDL CALIBRATOR . . . . . . . . . . . . . . . . . HD LD-4 . . . . . . . . . . . . . 103
-STANDARD KIT-
CHOLESTEROL Standard 200 mg/dL . . . . . . . . . . . . . . CHOL200-3 . . . . . . . . . . . . 104
Update CREATININE Standard 2 mg/dL . . . . . . . . . . . . . . . . . . . . CREN2-2 . . . . . . . . . . . . 105
GLUCOSE Standard 200 mg/dL . . . . . . . . . . . . . . . . . . GLUP100-1 . . . . . . . . . . . . 106
MICROPROTEIN Standard 20 mg/dL . . . . . . . . . . . . . . . PRTP20-1 . . . . . . . . . . . . 107
MICROPROTEIN Standard 100 mg/dL . . . . . . . . . . . . . PRTP100-1 . . . . . . . . . . . . 108
TRIGLYCERIDES Standard 200 mg/dL . . . . . . . . . . . . . TRIG200-1 . . . . . . . . . . . . 109
UREA Standard 50 mg/dL . . . . . . . . . . . . . . . . . . . . . . . . URUV50-1 . . . . . . . . . . . . 110
URIC ACID Standard 6 mg/dL. . . . . . . . . . . . . . . . . . . . . . ACUR6-1 . . . . . . . . . . . . 111
IMMUNOLOGY
AGGLUTINATION REAGENTS
Update ASO LATEX . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . LXAS-4 . . . . . . . . . . 117-118
Update CRP LATEX . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . LXCR-4 . . . . . . . . . 119-120
Update FR LATEX . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . LXRF-4 . . . . . . . . . 121-122
Update R.P.R. CARBON. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . LXRP-4 . . . . . . . . . 123-124
Update WAALER ROSE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . LXWR-4 . . . . . . . . . 125-126
RAPID TESTS
PREGTEST II . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . RTHC2-3 . . . . . . . . . 129-130
-RAPIDROG II-
Amphetamine. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . RTAM-2 . . . . . . . . . 131-132
Barbiturates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . RTBA-2 . . . . . . . . . 133-134
Benzodiazepines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . RTBZ-2 . . . . . . . . . 135-136
Cocaine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . RTCO-2 . . . . . . . . . 137-138
Methadone . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . RTMT-2 . . . . . . . . . 139-140
Morphine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . RTMO-2 . . . . . . . . . 141-142
Multi 4 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . RTDQ-3 . . . . . . . . . 143-146
THC . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . RTTH-3 . . . . . . . . . 147-148
OTHER REAGENTS
New PMR Test Amnicator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . PMRT-6. . . . . . . . . . . 151-152
ELISTRIP Urinary strip this technical insert is available on request

ELITECH reagents are elaborated and carefully
controlled to bring you the best satisfactions.
To get optimal performances, ELITECH advises you to follow closely

the technical sheets and these general instructions :
l Bring reagents to room temperature before use.
l Manipulation should be performed with clean materials.
l After rehydratation or preparation of working reagents (powder and freeze
dried powder), wait for 15 minutes at room temperature before use.
l Do not pipette the reagent directly in the vial in order to avoid contaminations.
l Close carefully the vial after use and take care of the storage conditions and sta-
bility instructions.
l For the Stable Liquid Reagents, during the stability period, a light reagent colo-
ration can appear without effecting the reagents performances.
l The calibration factor for the enzymatic kinetics is defined according to this
formula :
F = Vt x 10-3 x 1
Vs e L
Vt : Total volume
Vs : Sample volume
L : Light path length
e : Molar extinction coefficient
ELITECH is tuned in to you for all requests and techni-

cal support.
CLINICAL
CHEMISTRY
REAGENTS
ACID PHOSPHATASE
For in vitro diagnostic use only Ref.: PACI - 0030 18 x 3 mL
METHOD Note : Development of particles could appears in the rea-

Enzymatic- Fast red gents in the end of stability. It would not affect perfor-
Cinetic mances of this reagent.
PRINCIPLE WR 2 : Dissolve the reagent 2 in 5 mL of distilled water.

Acid phosphatase (ACP, EC 3.1.3.2) hydrolysis, in acidic Stability : Until expiry date at 2-8°C.
medium, of α-naphtylphosphate (α-NP) into α-naphtol and
phosphate. α-Naphtol reacts with diazo-2-chloro-5-toluene If crystallization occurs, warm at moderate temperature (40-
(Fast Red TR salt) forming an azo-dye compound. The rate of 50°C) until dissolved.
formation of the azo compound at 405 nm is proportional to
total acid phosphatase activity. SAMPLES
When the activity is measured in presence of tartrate, the Serum free of hemolysis. Serum must be separated from clot
prostatic activity is inhibited. The difference between total and within two hours after collection. Acid phosphatase activity is
resistant activities corresponds to the prostatic fraction. very labile at room temperature. Stabilization of the enzyme
ACP can only be achieved by acidifying with the acetate buffer pro-
α-Naphtylphosphate + H2O α-Naphtol + Inorganic vided. Add 20 µL (0.02 mL) of reagent 3 per mL of serum and
phosphate mix. Treated serum samples will remain stable for seven days
when kept refrigerated at 2-8°C. Do not use plasma. Some
α-Naphtol + Fast Red TR Diazodye anticoagulants inhibit acid phosphatase activity and/or cause
turbidity.
ACP = Acid phosphatase
NP ACP = Non prostatic acid phosphatase REFERENCE VALUES
30°C 37°C
Total acid phosphatase : < 9 U/L 2.5 - 11.7 U/L
REAGENTS COMPOSITION Prostatic acid phosphatase : < 3 U/L 0.2 - 3.5 U/L
Reagent 1 : R1
Citrate buffer, pH 5.30 80 mmol/L Note : It is recommended for each laboratory to establish and
α-Naphtylphosphate 3 mmol/L maintain its own reference values. The data given here are only
Fast Red TR salt 1 mmol/L an indication.
PROCEDURE
Reagent 2 : R2
This reagent can be used manually (see method below) and
L-Tartrate 2 mol/L on most analysers. The applications are available on request.
Reagent 3 : R3
Wavelength : 405 nm
Acetate buffer, pH 5.00 5 mol/L
Temperature : 37°C
Cuvette : 1 cm light path.
PRECAUTIONS
Use clean or single glass material only to avoid contamina-
Read against distllled water
tions.
STABILITY OF REAGENTS Total Non-Prostatic

When stored at 2-8° C and protected from light, the reagents Acid Phosphatase Acid phosphatase
are stable until the expiry date stated on the label.
WR 1 1 mL 1 mL
PREPARATION AND STABILITY WR 2 - 10 µL

OF WORKING REAGENTS
Sample 100 µL 100 µL
WR 1 : Dissolve the reagent 1 in the suitable volume of dis-
tilled water.
Mix and after a 5 minute incubation measure the change of
Stability : 1 day at 20-25°C
optical density per minute (∆OD/min.) during 3 minutes.
7 days at 2-8°C
.../...
(03/2005)
FTAN-PACI-4
SEPPIM S.A Zone Industrielle 61500 SEES FRANCE 11

ACID PHOSPHATASE
CALCULATION - Interferences
Total ACP : Activity (U/L) = ∆OD/min. x 853 According to SFBC recommendations (Vassault and Coll
NP ACP : Activity (U/L) = ∆OD/min. x 860 1986), studies have been performed to determine the level of
Prostatic fraction (U/L) = Total ACP (U/L) - NP ACP (U/L). interference from different compounds:
Haemoglobin : Negative bias from 50 µmol/L for

QUALITY CONTROL normal serum
To ensure adequate quality, control sera such as ELITROL I
Negative bias from 15 µmol/L for
(normal control) and ELITROL II (abnormal control) are recom-
pathological serum
mended.
Conjugated Bilirubin : Negative bias from 50 µmol/L.
PERFORMANCES DATA
The following data were obtained using COBAS MIRA or
ASCA analysers (37°C).
BIBLIOGRAPHY
Hillmann G., Z. Klin.Chem. Klin. Biochem, (1971), 9, 273.
- Analytical range
The reagent is linear up to 40 U/L.
If activity of sample is superior at 40 U/L, so dilute sample SYMBOLS USED ON LABELS :
1/10 with sodium chloride solution (9 g/L) and multiply result
by 10. Lot Number
- Precision Consult instruction for use

Within-run reproducibility
In vitro diagnostic medical device
Total acid phosphatase
Serum 1: Manufacturer’s address
n = 15 m= 8.7 U/L CV = 1.6 %
Serum 2 : Temperature limitation
n = 15 m = 33.3 U/L CV = 0.9 %
Expiration date
Prostatic acid phosphatase
Serum 1:
n = 15 m= 7.2 U/L CV = 7.9 %
Serum 2 :
n = 15 m = 29.4 U/L CV = 2.3 %
Between-run reproducibility
Total acid phosphatase
Serum 1:
n = 15 m= 7.8 U/L CV = 2.3 %
Serum 2 :
n = 15 m = 32.7 U/L CV = 1.1 %
(03/2005)
FTAN-PACI-4
): Important modification from the previous version

ALBUMIN
ALBUMINBCG
Ref.: ALBU - 0600 2 x 125 mL

For in vitro diagnostic use only Ref.: ALBU - 0700 4 x 250 mL
CLINICAL SIGNIFICANCE (1-5) PREPARATION AND STABILITY

Albumin, synthetised primarily by the liver, represents 50 to OF WORKING REAGENT
60% of total serum proteins. Because of its small size and its The reagent is ready for use
high plasmatic concentration, albumin is the major protein
component of most extravascular body fluid, including CSF, SAMPLES (4-5)
interstitial fluid, urine and amniotic fluid. Albumin’s primary - Specimen
function is the maintenance of colloidal osmotic pressure in
Serum.
both extravascular and vascular spaces, with continuous Heparinized plasma.
equilibration. Albumin also binds and transports a large num-
ber of compounds (ions, free fatty acids, bilirubin, drugs...). - Storage
Albumin is a mobile reserve of amino acids. Analyse fresh serum or store them at 4°C less than 72 hours.
Increased levels of albumin are present only in acute dehydra-
Stored at -20°C, sera are stable for 6 months. For a longer sto-
tation, especially critical for newborn.
rage, freeze samples at -70°C.
Hypoalbuminemia is seen in a multitude of diseases bound to
different pathological states: 1) acute and chronic inflamma-
tion, 2) decreased synthesis: hepatic insufficiency, malnutri-
REFERENCE VALUES (3)
tion, analbuminemia, 3) increased loss: nephritic syndrom, Ambulatory patients Patients at rest
gastrointestinal loss, sever and large burns, bedsore, 4) 3.8 - 5.5 g/dL 3.5 - 5.2 g/dL
increased catabolism: fever, hyperthyroidism... 38 - 55 g/L 35 - 52 g/L
METHOD (6-8)
Note : It is recommended for each laboratory to establish and
Colorimetric maintain its own reference values. The given data here are only
Bromocresol green (BCG) an indication.
PRINCIPLE (6-8)
PROCEDURE
Colorimetric determination of serum albumin using bromocre-
sol green (BCG) at pH 4.20.
on most analysers.
The applications are available on request.
pH = 4,20
Albumin + BCG Albumin-BCG complex Wavelength : 628 nm
Temperature : 37°C
Cuvette : 1 cm light path
REAGENTS COMPOSITION
Read against reagent blank.
Reagent : R
BLANK STANDARD SAMPLE
Succinate buffer, pH 4.20 87 mmol/L
Bromocresol green 0.2 mmol/L Reagent 1 mL 1 mL 1 mL
Brij 35 7.35 ml/L Distilled water 10 µL - -
Standard - 10 µL -
Standard : Std Sample - - 10 µL
Bovine albumin 5 g/dL
Mix and read the optical density (OD) after a 5 minute incu-
50 g/L
bation. The final colour is stable for at least 15 minutes.
PRECAUTIONS
- The standard contains less than 0.1 % sodium azide. Sodium CALCULATION
azide. Sodium azide can react with copper and lead plumbing
OD Sample g/dL n= 5
to form explosive metal azides.
Regulations currently in use regarding dangerous waste elimi- xn g/L n= 50
nation must be respected. If discharge in the canalisations, OD Standard
rinse with plenty of water. n = standard concentration.
- Use clean or single use glass material only to avoid conta-
minations. CALIBRATION
Albumin standard is traceable until the Certified Reference
STABILITY OF REAGENTS material, CRM 470.
On Cobas Mira, calibration must be performed at least every
When stored at 2-8° C and protected from light, the reagents
15 days, after each change of batch and according to quality
and the standard are stable until the expiry date stated on the
control results. .../...
label.
(03/2005)
FTAN-ALBU-4

ALBUMIN
QUALITY CONTROL Haemoglobin : No significant interference up to 500 mg/dL

(5 g/L). Positive bias from 300 mg/dL (3 g/L)
To ensure adequate quality, control sera such as ELITROL I for low level sera.
mended. Glucose : No significant interference up to 500mg/dL
(5g/L, 27 mmol/L).
PERFORMANCE DATA
Turbidity : No significant interference up to 600 mg/dL
The following data were obtained using the COBAS MIRA Triglycerides equivalent ( 6 g/L, 6.9 mmol/L) .
analyser (37°C)
Sodium salicylate: No significant interference up to
- Analytical range 250 mg/dL (2.5 g/L).
The reagent is linear from 1.5 to 6 g/dL (15 to 60 g/L).
BIBLIOGRAPHY
- Detection limit (9)
1.Christensen, S.E., Proteins, Clinical Chemistry: Concepts
Determined according to SFBC protocol, the detection limit is and Applications, Anderson, S.C., Cockayne, S. (W.B.
equal to 0.1 g/dL (1 g/L). Saunders eds. Philadelphia USA). (1993), 188.
2.Funes, A., Albumine, Guide des analyses spécialisées,
- Sensitivity Laboratoire Cerba Ed., (1995), 63.
The average variation of the analytical signal is 134 × 10-3 ∆A 3.Johnson, A.M., Rohlfs, E.M., Silverman, L. M., Proteins,
per g/dL of albumin (or 13.4 × 10-3 ∆A per g/L), for a light Tietz Fundamentals of Clinical Chemistry, 5th Ed., Burtis,
C.A., Ashwood, E.R., (W.B. Saunders eds. Philadelphia USA),
path of 1 cm.
(2001), 325.
- Precision 4.Tietz, N.W. Clinical Guide to Laboratory Tests, 3ème Ed.,
Saunders, (1995), 22-25.
5.Scherwin, J.E, Liver function. Clinical Chemistry: Theory,
Low level : n = 20 m = 2.58 g/dL CV = 1.7 %
Analysis, Correlation, 4th Ed., Kaplan, L.A, Pesce, A.J., Kaz-
Medium level : n = 20 m = 3.54 g/dL CV = 1.2 % mierczak, S.C., (Mosby Inc. eds St Louis USA), (2003), 492.
High level : n = 20 m = 4.54 g/dL CV = 1.2 % 6.Doumas, B., et al.., Albumin standards and the measurement
of serum albmin with bromocresol green, Clin. Chem. Acta.,
Between-run reproducibility (1971), 31, 87.
Low level : n = 20 m = 2.65 g/dL CV = 2.6 % 7.Doumas, B.T., Biggs, H.G., Determination of serum albumin,
Medium level : n = 20 m = 3.41 g/dL CV = 2.1 % Standard Methods of Clinical Chemistry, (Acad. Press N.Y.),
(1972), 7,175.
High level : n = 20 m = 4.39 g/dL CV = 1.9 %
8.Drupt, F., Dosage de l'albumine sérique par le vert de bromo-
- Correlation crésol, Pharm. Biol., (1974), 9, 777.
A comparative study has been performed between Elitech 9.Vassault, A., et al., Protocole de validation de techniques.
method and another commercial reagent on 31 human serum (Document B, stade 3) Ann. Biol. Clin., (1986), 44, 686.
samples.The sample concentrations were between 1.07 and
6.11 g/dL. The parameters of linear regression are as follows:
Correlation coefficient (r) : 0.9984 SYMBOLS USED ON LABELS :
Linear regression : y = 0.911 x + 0.35 g/dL
Lot number
- Interferences (9)
Consult instruction for use
According to SFBC recommendations some studies have been
performed to determine the level of interference from different In vitro diagnostic medical device
compounds:
Unconjugated Bilirubin: No significant interference up to Manufacturer’ s address
36 mg/dL (360 mg/L, 616 µmol/L).
Temperature limitation
Conjugated Bilirubin : No significant interference up to
Expiration date
25 mg/dL (250 mg/L, 427µmol/L).
Ascorbic acid : No significant interference up to

40 mg/dL of ascorbic acid (400 mg/L,
2.2 mmol/L).
(03/2005)
FTAN-ALBU-4

ALT/GPT 4+1 SL
Ref.: ALSL - 0410 2 x 62.5 mL

Ref.: ALSL - 0430 4 x 62.5 mL
For in vitro diagnostic use only Ref.: ALSL - 0510 5 x 125 mL
CLINICAL SIGNIFICANCE (1-4) STABILITY OF REAGENTS

Alanine aminotransferase (ALT) also known as glutamate When stored at 2-8°C and protected from light, the reagents
pyruvate transaminase (GPT) is a transaminase. ALT catalyses are stable until the expiry date stated on the label.
the transfer of the amino group of L-alanine to α-ketoglutarate
to give L-glutamate. The highest levels are found in the liver PREPARATION AND STABILITY
and the kidneys, and in smaller amounts in heart and skele-
tal muscle. OF WORKING REAGENT
ALT concentration is increased when hepatic cells are dama- One-reagent procedure
ged (liver cell necrosis or injury of any cause). Indeed, viral and Mix 4 volumes of the reagent R1 with 1 volume of the reagent R2.
toxic hepatitis induce a marked elevation of ALT activity in Stability : 5 days at 20-25°C
serum. Intake of alcohol, delirium tremens, and administra- 2 weeks at 2-8°C
tion of various drug induce slight or moderate elevation of ALT.
ALT concentration in serum is also slightly increased in Two-reagent procedure
various conditions such as: muscular dystrophy, hemolytic The reagents are ready for use.
disease, myocardial infarction… SAMPLES (3)
ALT is more liver specific than AST (Aspartate aminotransfe- - Specimen
rase). Measurement of both AST and ALT has some value in Serum free from hemolysis.
distinguishing hepatitis from other parenchymal lesions.
Heparinized plasma.
ALT serum level can decrease in case of vitamin B6 deficiency.
- Storage
ALT is stable in serum for 3 days at room temperature or 1
METHOD (5)
week at 4°C. A marked decrease is seen following freeze/thaw
IFCC method without pyridoxal phosphate (P-5’-P).
cycles.
Kinetic. UV.
PRINCIPLE (5)
Serum, plasma (37°C): < 40 U/L
Kinetic determination of the alanine aminotransferase (ALT)
activity: Note : It is recommended for each laboratory to establish and
maintain its own reference values. The data given here are only
ALT an indication.
L-Alanine + α-Ketoglutarate Pyruvate + L-Glutamate
PROCEDURE
LDH
Pyruvate + NADH + H+ L-Lactate + NAD+ These reagents can be used on most analysers. The applica-
tions are available on request.
LDH = Lactate dehydrogenase. Wavelength : 340 nm
Temperature : 37°C
Read against distilled water.
Reagent 1: R1
Tris buffer, pH 7.50 (30°C) 125 mmol/L One-reagent procedure
L-Alanine 680 mmol/L
LDH ≥ 2000 U/L Working reagent : 200 µL
Reagent 2: R2 Sample : 20 µL
α-Ketoglutarate 97 mmol/L Mix and after a 50 second incubation, measure the change of
NADH 1.1 mmol/L absorbance per minute (∆A/min.) during 175 seconds.
PRECAUTIONS • Two-reagent procedure
- The reagents contain less than 0.1% sodium azide. Sodium
azide can react with copper and lead plumbing to form explo- R1 : 200 µL
sive metal azides. R2 : 50 µL
Regulations currently in use regarding dangerous waste elimi-
nation must be respected. If discharge in the canalisations, Mix, wait 25 seconds and add:
rinse with plenty of water.
- Use clean or single use laboratory equipment only to avoid Sample : 25 µL
contaminations. Mix and after a 50 second incubation, measure the change of
- High ALT values may induce falsely low results due to the absorbance per minute (∆A/min.) during 150 seconds.
depletion of the substrate (total consumption of NADH before
.../...
reading of the result). If an analyser is used, verify the pre-
sence of a depletion factor on the application.
(01/2005)
FTAN-ALSL4/1-3

ALT/GPT 4+1 SL
CALCULATION - Interferences (6,7)

At 340 nm, with the one-reagent procedure and the two-rea- According to SFBC recommendations, studies have been per-
gent procedure for a 1 cm light path cuvette: formed to determine the level of interference from different
Activity (U/L) = ∆A/min. x 1746 compounds:
Glucose: No significant interference up to 500 mg/dL (5 g/L,
QUALITY CONTROL 28 mmol/L).
To ensure adequate quality, control sera such as ELITROL I Ascorbic acid: No significant interference up to 40 mg/dL (400
(normal control) and ELITROL II (abnormal control) are recom- mg/L, 2.3 mmol/L).
mended. Pyruvate: No significant interference up to 2 mg/dL (20 mg/L,
0.23 mmol/L).
PERFORMANCE DATA
Unconjugated Bilirubin: Negative bias from 16 mg/dL (160
The following data were obtained using the COBAS MIRA
mg/L, 270 µmol/L).
analyser with the one and the two-reagent procedure
(37°C) Conjugated Bilirubin: Negative bias from 11,5 mg/dL (115
mg/L, 200 µmol/L).
- Analytical range Turbidity: No significant interference up to 600 mg/dL
The reagent is linear from 15 to 250 U/L. Triglyceride equivalent (6 g/L, 6.9 µmol/L).
Methyl-dopa: No significant interference up to 5 mg/dL (50
- Detection limit (6) mg/L).
Determined according to SFBC protocol, the detection limit is
equal to 2 U/L for the one-reagent procedure and to 3 U/L for Note: Hemolysed sera should not be used since significant
the two-reagent procedure. hemolysis may increase ALT concentration because of high
levels of ALT in erythrocytes.
- Sensitivity
The average variation of the analytical signal is 0.57 m∆A/min
per U/L of ALT for a light path of 1 cm. BIBLIOGRAPHY
1.Henderson, A.R., Moss, D.W., Enzymes, Tietz Fundamen-
- Precision tals of Clinical Chemistry, 5th Ed., Burtis, C.A. & Ashwood,
Within-run reproducibility: E.R. (W.B. Saunders eds. Philadelphia USA), (2001), 352.
2.Tietz, N.W., Clinical guide to laboratory tests. 3rd Ed., (W.B.
One-reagent procedure Two-reagent procedure Saunders eds. Philadelphia USA), (1995), 20.
Mean Mean 3.Scherwin, J.E, Liver function. Clinical Chemistry: Theory,
n CV (%) n CV (%)
(U/L) (U/L) Analysis, Correlation, 4th Ed., Kaplan, L.A, Pesce, A.J.,
SH 1 20 25 2.3 20 24 4.6 Kazmierczak, S.C., (Mosby Inc. eds St Louis USA), (2003), 492
SH 2 20 58 2.2 19 56 2.0 and appendix.
SH 3 20 195 1.0 20 199 1.3 4.Ward, M.K., Cockayne, S., Enzymology. Clinical Chemistry:
Concepts and Application, Anderson, S.C., Cockayne, S. (W.B.
Between-run reproducibility: Saunders eds. Philadelphia USA), (1993), 238.
5.Bergmeyer, H.U., Horder, M., Rej, R., Approved recommenda-
One-reagent procedure Two-reagent procedure
tion (1985) on IFCC methods for the measurement of catalytic
Mean Mean concen-tration of enzymes. Part 3. IFCC method for alanine ami-
n CV (%) n CV (%)
(U/L) (U/L) notransferase. J. Clin. Chem. Clin. Biochem., (1986), 24, 481.
SH 1 80 28 4.7 73 27 6.5 6.Vassault, A., et al., Protocole de validation de techniques.
SH 2 80 57 2.9 79 58 4.6 (Document B, stade 3) Ann. Biol. Clin., (1986), 44, 686.
SH 3 80 196 2.2 79 203 2.4 7.Vassault A., et al., Analyses de biologie médicale: spécifica-
tions et normes d’acceptabilité à l’usage de la validation des
techniques. Ann. Biol. Clin., (1999), 57, 685.
- Correlation
A comparative study has been performed between Elitech SYMBOLS USED ON LABELS :
method and another commercial reagent on 96 human sera.
The sample concentrations ranged from 2 to 288 U/L. Lot number
The parameters of linear regressions are as follows:
One-reagent Two-reagent
procedure procedure In vitro diagnostic medical device
Correlation
0.999 0.999 Manufacturer’s address
coefficient (r)
Linear regression y = 0.94 x + 1.7 y = 0.95 x - 0.9 Expiration date
(01/2005)
Temperature limitation FTAN-ALSL4/1-3

ALT/GPT
A LT ( G P T )
Ref : ALAT - 0030 20 x 3 mL

Ref : ALAT - 0200 12 x 20 mL
For in vitro diagnostic use only Ref : ALAT - 0400 9 x 50 mL
PRINCIPLE
PROCEDURE
Kinetic determination of alanine aminotransferase (ALT) based
upon IFCC recommendations :
on most analysers.
ALT
L-Alanine + α-Ketoglutarate Pyruvate+L-Glutamate
LDH Wavelength : 340 nm (334-365)
Pyruvate + NADH + H+ L-Lactate + NAD+ Temperature : 30°C, 37°C
ALT = Alanine aminotransferase
LDH = Lactate dehydrogenase Read against distilled water
Working reagent : 1 mL
Sample : 100 µL
Reagent 1 : R1
Mix and after a 1 minute incubation, measure the change of
Tris buffer, pH 7.50 110 mmol/L optical density per minute (∆OD/min.) during 3 minutes.
L-Alanine 550 mmol/L
CALCULATION
Reagent 2 : R2 340 nm : Activity (U/L) = ∆OD/min. x 1 746
334 nm : Activity (U/L) = ∆OD/min. x 1 780
LDH 1 200 U/L
NADH 0.20 mmol/L
QUALITY CONTROL
α-Ketoglutarate 16 mmol/L
PRECAUTION (normal control) and ELITROL II (abnormal control) are recom-
The reagent 1 contains less than 0.1 % sodium azide. mended.
STABILITY OF REAGENTS LINEARITY

When stored at 2-8° C and protected from light, the reagents If ∆OD/min. exceeds 0.150 at 340 nm, repeat test using serum
are stable until the expiry date stated on the label. diluted 1/10 with sodium chloride solution (9 g/L). Multiply
result by 10.
PREPARATION AND STABILITY
OF WORKING REAGENT BIBLIOGRAPHY
Expert Panel on enzyme of the IFCC, Clin. Chim. Acta, 70,
Dissolve the reagent 2 in the suitable volume of reagent 1. (1976), F19.
Stability : 5 days at 20-25°C
4 weeks at 2-8°C SYMBOLS USED ON LABELS :
Lot number
SAMPLES
Serum free of hemolysis. Consult instruction for use
Heparin or EDTA plasma.
REFERENCE VALUES Manufacturer’ s address

Without pyridoxal-5-phosphate
30°C 37°C
Expiration date
up to 35 U/L up to 49 U/L

an indication.
(01/2005)
FTAN-ALAT-3

AMYLASE SL
Ref : AMSL - 0390 1 x 50 mL

Ref : AMSL - 0395 3 x 50 mL
For in vitro diagnostic use only Ref : AMSL - 0400 6 x 50 mL
PRINCIPLE PROCEDURE
Substrate CNP-G3 (2-chloro-4-nitrophenyl-a-maltotrioside) is This reagent can be used manually (see method below) and
directly hydrolyzed by a-amylase to produce CNP monitored at on most analysers.
405 nm during incubation of the reagent with a sample. The applications are available on request.
Wavelength : 405 nm
Amylase Temperature : 37°C, 30°C
5 CNP-G3 3 CNP + 2 CNP-G2 + 3 Maltotriose + 2 Glucose Cuvette : 1 cm light path
CNP = 2-Chloro-4-nitrophenol Read against distilled water.

CNP-G2 = 2-Chloro-4-nitrophenyl-α-maltoside
37° C 30° C
REAGENT COMPOSITION
Working reagent 1 mL 1 mL
MES buffer, pH 6.00 50 mmol/L Sample 15 µL 25 µL
Sodium chloride 70 mmol/L
Calcium chloride 6 mmol/L
Activator 900 mmol/L Mix and after a 1 minute incubation, measure the change of
CNP-G3 2.27 mmol/L optical density per minute (∆OD/min.) during 3 minutes.
PRECAUTIONS CALCULATION
The reagent contains less than 0.1 % sodium azide.
Activity (U/L) = ∆OD/min. x 4 640 at 37°C
This reagent is very sensitive to external contamination
∆OD/min. x 2 715 at 30°C
(saliva, sweat, ...).
Handle with gloves and keep the vial tightly sealed after use. Take dilution factor into account for the calculation of the acti-
Avoid direct exposure to light. vity in urine.
Stability OF REAGENT
When stored at 2-8° C and protected from light, the reagent is QUALITY CONTROL
stable until the expiry date stated on the label. To ensure adequate quality, control sera such as ELITROL I
PREPARATION AND STABILITY mended.
OF WORKING REAGENT
The reagent is ready for use. LINEARITY
SAMPLES Up to 900 U/L
Serum. If ∆OD/min. exceeds 0.190 at 405 nm, repeat test using sam-
Heparin plasma. ple diluted 1/10 with sodium chloride solution (9 g/L).
Urine diluted 1/3 with distilled water. Multiply result by 10.
REFERENCE VALUES BIBLIOGRAPHY

30° C 37°C Winn-Deen, E.S., David, H. Sigler E. and Chavez R., Clin.
Serum, plasma < 67 U/L < 86 U/L Chem., 34, 10, (1988), 2005.
Urine < 369 U/L < 470 U/L
As amylase is generally measured by hydrolysis of different SYMBOLS USED ON LABELS :
non natural substrates (p-NP-G7, EPS or CNP-G3), units
obtained can change widely for each substrate. For instance Lot number
600 U/L are obtained by EPS, 210 U/L by p-NP-G7 or 230 U/L
by CNP-G3.
maintain its own reference values. The data given here are only Manufacturer’ s address
an indication.
Expiration date
(01/2005)
FTAN-AMSL-2

AMYLASE
For in vitro diagnostic use only Ref : AMYL - 0030 20 x 3 mL
PRINCIPLE Note : It is recommended for each laboratory to establish and

The α-Amylase hydrolyzes the blocked p-nitro-phenylmalto- maintain its own reference values. The data given here are only
heptaoside producing glucose polymers and p-nitrophenol an indication.
oligosaccharides with shorter chain. These are further hydro-
lyzed by glucoamylase and a-glucosidase to release p-nitro- PROCEDURE
phenol. The increase in absorbance at 405 nm is proportional This reagent can be used manually (see method below) and
to the a-amylase activity. on most analysers.
REAGENTS COMPOSITION Wavelength : 405 nm
Reagent 1 : R1 Temperature : 25°C, 30°C, 37°C
Pipes buffer, pH 6.90 50 mmol/L Cuvette : 1 cm light path
Calcium chloride 350 mmol/L Read against distilled water.
Reagent 2 : R2 Working reagent : 1 mL

p-nitrophenylmaltoheptaoside (blocked) 1.0 mmol/L
Glucoamylase ≥ 3 000 U/L Sample : 25 µL
α-Glucosidase ≥ 10 000 U/L
PRECAUTIONS
The reagent 1 contains less than 0.1 % sodium azide.
CALCULATION
This reagent is very sensitive to external contamination
(saliva, sweat, ...). Activity (U/L) = ∆OD/min. x 4 824 at 37°C
∆OD/min. x 4 939 at 30°C
Handle with gloves and keep the vial tightly sealed after use.
∆OD/min. x 5 256 at 25°C
Avoid direct exposure to light.
Take dilution factor into account for the calculation of the acti-
vity in urine.
STABILITY OF REAGENTS
When stored at 2-8° C and protected from light, the reagents QUALITY CONTROL
are stable until the expiry date stated on the label. To ensure adequate quality, control sera such as ELITROL I
OF WORKING REAGENT
Dissolve the reagent 2 in the suitable volume of reagent 1. LINEARITY
If ∆OD/min. exceeds 0.250 at 405 nm, repeat test using sam-
ple diluted 1/10 with sodium chloride solution (9 g/L).
3 weeks at 2-8°C Multiply result by 10.
For 3 mL reagent :
3 days at 20-25°C BIBLIOGRAPHY
1.Marshall and al., Chimica Acta, 76, (1977), 277.
2 weeks at 2-8°C
2.Marshall, Analytical Biochemistry, 85, (1978), 541.
SAMPLES
Serum.
Heparin plasma. SYMBOLS USED ON LABELS :
Urine diluted 1/3 with distilled water.
Lot number
REFERENCE VALUES
25°C 30°C 37°C
Serum, plasma < 40 U/L < 55 U/L < 90 U/L In vitro diagnostic medical device
Urine < 190 U/L < 240 U/L < 490 U/L
24 h urine < 110 U/24h < 170 U/24h < 450 U/24h Manufacturer’ s address
As amylase is generally measured by hydrolysis of different
non natural substrates (p-NP-G7, EPS or CNP-G3), units
obtained can change widely for each substrate. For instance Expiration date
600 U/L are obtained by EPS, 210 U/L by p-NP-G7 or 230 U/L (01/2005)
by CNP-G3. FTAN-AMYL-4

AST/GOT 4+1 SL
Ref.: ASSL - 0410 2 x 62.5 mL

Ref.: ASSL - 0430 4 x 62.5 mL
For in vitro diagnostic use only
Ref.: ASSL - 0510 5 x 125 mL

Aspartate aminotransferase (AST) also known as glutamate oxa- When stored at 2-8°C and protected from light, the reagents are
loacetate transaminase (GOT) is a transaminase. AST catalyses the
stable until the expiry date stated on the label.
transfer of the aminogroup of L-aspartate to α-ketoglutarate to give
L-glutamate. AST is widely distributed in the body, but the highest
levels are found in heart, liver, skeletal muscles and kidneys.
Damages to cells of these tissues induce AST increase in serum. In
OF WORKING REAGENT
case of fulminant forms of hepatitis, especially viral hepatitis the One-reagent procedure
enzyme level is markedly elevated. In case of myocardial infarction, Mix 4 volumes of the reagent R1 with 1 volume of the reagent R2.
AST activity increases and reaches a peak after 18-24 hours. The Stability : 5 days at 20-25°C
activity falls back to normal after 4-5 days, provided no new infarct 2 weeks at 2-8°C
has occurred.
The following pathological states are examples of disorders also Two-reagent procedure
resulting in an increase of enzyme activity: liver cell necrosis or The reagents are ready for use.
injury of any cause (for example intake of alcohol, delirium tre-
mens, and administration of drug induce moderate AST elevation), SAMPLES (2,3)
alcoholic hepatitis, muscular dystrophy and gangrene, infectious - Specimen
mononucleosis, acute pancreatitis, heart affection as myocarditis Serum free from hemolysis.
or pericarditis, pulmonary emboli…. Heparinized or EDTA plasma.
On the contrary, AST serum level can decrease in case of vitamin
B6 deficiency. - Storage
Sera are stable 24 hours at room temperature, 28 days at 4°C and
METHOD (5) at least 1 year at -20°C.
IFCC method without pyridoxal phosphate (P-5’-P).
Kinetic. UV.
Serum, plasma (37°C): < 40 U/L

PRINCIPLE (5) Reference values for infants are higher than for adults.
Kinetic determination of the aspartate aminotransferase (AST)
activity:
maintain its own reference values. The data given here are only an
AST indication.
L-Aspartate + α-Ketoglutarate Oxaloacetate + L-Glutamate
MDH PROCEDURE
Oxaloacetate + NADH + H+ L-Malate + NAD+
These reagents can be used on most analysers. The applications
MDH = Malate dehydrogenase. are available on request.
Wavelength : 340 nm
Temperature : 37°C
Reagent 1: R1
Tris buffer, pH 7.80 (30°C) 100 mmol/L One-reagent procedure
L-Aspartate 330 mmol/L
LDH ≥ 2000 U/L Working reagent : 200 µL
MDH ≥ 1000 U/L Sample : 20 µL
Reagent 2: R2 Mix and after a 50 second incubation, measure the change of

α-Ketoglutarate 78 mmol/L absorbance per minute (∆A/min.) during 175 secondes.
NADH 1.1 mmol/L
• Two-reagent procedure
PRECAUTIONS
- The reagents contain less than 0.1 % sodium azide. Sodium azide R1 : 200 µL
can react with copper and lead plumbing to form explosive metal R2 : 50 µL
azides.
Regulations currently in use regarding dangerous waste elimina- Mix, wait 25 seconds and add:
tion must be respected. If discharge in the canalisations, rinse
with plenty of water. Sample : 25 µL
- Use clean or single use laboratory equipment only to avoid conta-
Mix and after a 50 second incubation, measure the change of
minations.
absorbance per minute (∆A/min.) during 150 seconds.
- High AST values may induce falsely low results due to the deple- .../...
tion of the substrate (total consumption of NADH before reading of
the result). If an analyser is used, verify the presence of a deple-
tion factor on the application. (01/2005)
FTAN-ASSL4/1-3

AST/GOT 4+1 SL
CALCULATION - Interferences (6,7)

At 340 nm, with the one-reagent procedure and the two-reagent According to SFBC recommendations, studies have been perfor-
procedure for a 1 cm path light cuvette: med to determine the level of interference from different com-
Activity (U/L) = ∆A/min. x 1746 pounds:
Glucose: No significant interference up to 500 mg/dL (5 g/L, 28
mmol/L).
QUALITY CONTROL
Ascorbic acid: No significant interference up to 40 mg/dL (400
To ensure adequate quality, control sera such as ELITROL I (nor-
mg/L, 2.3 mmol/L).
mal control) and ELITROL II (abnormal control) are recommended.
Pyruvate: No significant interference up to 2 mg/dL (20 mg/L, 0.23
PERFORMANCE DATA mmol/L).
Unconjugated Bilirubin: Negative bias from 17.5 mg/dL (175
The following data were obtained using the COBAS MIRA analy-
mg/L, 300 µmol/L).
ser with the one and the two-reagent procedure (37°C)
Conjugated Bilirubin: Negative bias from 11.5 mg/dL (115 mg/L,
- Analytical range 200 µmol/L).
The reagent is linear from 10 to 250 U/L. Turbidity: No significant interference up to 600 mg/dL Triglyceride
equivalent (6 g/L, 6.9 µmol/L).
Methyl-dopa: No significant interference up to 5 mg/dL (50 mg/L).
equal to 2 U/L.
Note: Hemolysed sera should not be used since significant hemo-
- Sensitivity lysis may increase AST concentration because of high levels of AST
The average variation of the analytical signal is 0.57 m∆A/min per in erythrocytes.
U/L of AST for a light path of 1 cm.
BIBLIOGRAPHY
- Precision 1.Henderson, A.R., Moss, D.W., Enzymes, Tietz Fundamentals of
Within-run reproducibility: Clinical Chemistry, 5th Ed., Burtis, C.A. & Ashwood, E.R. (W.B.
Saunders eds. Philadelphia USA), (2001), 352.
One-reagent procedure Two-reagent procedure
2.Tietz, N.W., Clinical guide to laboratory tests, 3rd Ed., (W.B.
Mean Mean
n CV (%) n CV (%) Saunders eds. Philadelphia USA), (1995), 76.
(U/L) (U/L)
SH 1 20 18 3.9 20 18 4.5
Analysis, Correlation, 4th Ed., Kaplan, L.A, Pesce, A.J., Kaz-mierc-
SH 2 20 49 3.0 19 50 4.0 zak, S.C., (Mosby Inc. eds St Louis USA), (2003), 492 and appen-
SH 3 20 230 0.8 20 231 1.2 dix.
4.Ward, M.K., Cockayne, S., Enzymology. Clinical Chemistry:
Between-run reproducibility: Concepts and Application, Anderson, S.C., Cockayne, S. (W.B.
One-reagent procedure Two-reagent procedure 5.Bergmeyer, H.U., Horder, M., Rej, R. Approved recommendation
Mean Mean (1985) on IFCC methods for the measurement of catalytic concen-
n CV (%) n CV (%) tration of enzymes. Part 2. IFCC method for aspartate aminotrans-
(U/L) (U/L)
ferase. J. Clin. Chem. Clin. Biochem., (1986), 24, 497.
SH 1 80 18 4.8 80 18 7.1
6.Vassault, A., et al., Protocole de validation de techniques.
SH 2 79 46 4.0 77 46 6.3 (Document B, stade 3) Ann. Biol. Clin., (1986), 44, 686.
SH 3 80 222 2.9 80 221 2.8
7.Vassault A., et al., Analyses de biologie médicale: spécifica-
tions et normes d’acceptabilité à l’usage de la validation des
- Correlation techniques. Ann. Biol. Clin., (1999), 57, 685.
A comparative study has been performed between Elitech method
and another commercial reagent on 86 human sera. The sample SYMBOLS USED ON LABELS :
concentrations ranged from 5 to 250 U/L.
The parameters of linear regressions are as follows :
Lot number
One-reagent Two-reagent
procedure procedure Consult instruction for use
Correlation In vitro diagnostic medical device
0.996 0.999
coefficient (r)
Linear regression y = 0.97 x + 0.7 y = 0.94 x + 0.7 Manufacturer’s address
Expiration date
Temperature limitation (01/2005)

FTAN-ASSL4/1-3

AST/GOT
Ref : ASAT - 0030 20 x 3 mL

Ref : ASAT - 0200 12 x 20 mL
For in vitro diagnostic use only Ref : ASAT - 0400 9 x 50 mL
PRINCIPLE PROCEDURE
Kinetic determination of the aspartate aminotransferase (AST) This reagent can be used manually (see method below) and
based upon IFCC recommendations : on most analysers.
AST
L-Aspartate + a-Ketoglutarate Oxaloacetate + L-Glutamate. Wavelength : 340 nm (334-365)
Temperature : 30°C, 37°C
MDH
Oxaloacetate + NADH + H+ L-Malate + NAD+ Cuvette : 1 cm light path

AST = Aspartate aminotransferase.
MDH = Malate dehydrogenase. Working reagent : 1 mL
Sample : 100 µL
Reagent 1 : R1 optical density per minute (∆OD/min.) during 3 minutes.
Tris buffer, pH 7.80 88 mmol/L
L-Aspartate 260 mmol/L CALCULATION
Reagent 2 : R2 365 nm : Activity (U/L) = ∆OD/min. x 3 235
MDH ≥ 600 U/L
QUALITY CONTROL
LDH ≥ 900 U/L
NADH 0.20 mmol/L
α-Ketoglutarate 12 mmol/L mended.
PRECAUTIONS
The reagent 1 contains less than 0.1 % sodium azide. LINEARITY
If ∆OD/min. exceeds 0.150 at 340 nm, repeat test using serum
diluted 1/10 with sodium chloride solution (9 g/L). Multiply
result by 10.
BIBLIOGRAPHY
Expert panel on enzyme of the IFCC, Clin. Chim. Acta, 70,
(1976), F19.
OF WORKING REAGENT
Dissolve the reagent 2 in the suitable volume of reagent 1.
SYMBOLS USED ON LABELS :
Lot number
4 weeks at 2-8°C
SAMPLES
Serum free of hemolysis.
Heparin or EDTA plasma. Manufacturer’ s address
REFERENCE VALUES Temperature limitation
Without pyridoxal-5-phosphate Expiration date

30°C 37°C
up to 30 U/L up to 46 U/L

an indication. (01/2005)
FTAN-ASAT-3

BILIRUBIN
TOTAL & DIRECT
Ref : BILI - 0600 TOTAL 125 mL

DIRECT 125 mL
Ref : BILI - 0620 DIRECT 2 x 125 mL
Ref : BILI - 0640 TOTAL 2 x 125 mL
PRINCIPLE REFERENCE VALUES

Sulfanilic acid reacts with sodium nitrite to form diazotized Total bilirubin : < 1.0 mg/dL
sulfanilic acid. In the presence of dimethylsulfoxide, total bili- < 10 mg/L
rubin reacts with diazotized sulfanilic acid to form azobiliru- < 17 µmol/L
bin. In the absence of dimethylsulfoxide, only the direct biliru-
bin reacts to give azobilirubin. Direct bilirubin : < 0.3 mg/dL
< 3 mg/L
REAGENTS COMPOSITION < 5.1 µmol/L
A) Total Bilirubin : Note : It is recommended for each laboratory to establish and

Reagent 1 : R1
an indication.
Sulfanilic acid 28.9 mmol/L
Hydrochloric acid 165 mmol/L PROCEDURE
Dimethylsulfoxide 7 mol/L
Reagent 2 : R2 on most analysers.
Sodium nitrite 43 mmol/L The applications are available on request.
B) Direct Bilirubin : Wavelength : 555 nm (530-580)
Temperature : 37°C
Reagent 1 : R1
Sulfanilic acid 28.9 mmol/L
Hydrochloric acid 165 mmol/L A) Total bilirubin
Reagent 2 : R2
Sample Sample Calibrator Calibrator
Sodium nitrite 43 mmol/L blank blank
Calibrator : Cal Reagent 1 1.5 mL 1.5 mL 1.5 mL 1.5 mL
Use Calibrator ref. : BIEN-4050. Reagent 2 - 50 µL - 50 µL
Not provided with the kit. Sample 100 µL 100 µL - -
Calibrator - - 100 µL 100 µL
PRECAUTIONS
IRRITANT! The reagent 1 of Total Bilirubin contains the dime- Mix and read the optical density (OD) after a 5 minute incubation.
thylsulfoxide (55 %). The final colour is stable for at least 1 hour.
Irritant for the eyes , the respiratory system and skin.
Avoid direct exposure to light. B) Direct bilirubin
Some interferences with protein coated on analysers tubes can

be avoided by rinse with a 0.1 N NaOH solution. Sample Sample Calibrator Calibrator
blank blank
STABILITY OF REAGENTS Reagent 1 1.5 mL 1.5 mL 1.5 mL 1.5 mL

Reagent 2 - 50 µL - 50 µL
are stable until the expiry date stated on the label. Sample 100 µL 100 µL - -
Calibrator - - 100 µL 100 µL
Mix and read the optical density (OD) after a 5 minute incubation.
OF WORKING REAGENT
The final colour is stable for at least 1 hour.
The reagents are ready for use.
SAMPLE
Heparin plasma.
.../...
(01/2005)
FTAN-BILI-2

BILIRUBIN
TOTAL & DIRECT
CALCULATION
With Factor : (OD sample - OD sample blank) x F
Total bilirubin Direct bilirubin
mg/dL F = 21.6 F = 16.8
mg/L F = 216 F = 168
µmol/L F = 367 F = 286
With Calibrator : OD Sample - OD Sample blank

xn
OD Calibrator - OD Calibrator blank
n = Calibrator concentration
QUALITY CONTROL
mended.
LINEARITY
Total bilirubin : up to 20 mg/dL (200 mg/L) (340 µmol/L)
Direct bilirubin : up to 18 mg/dL (180 mg/L) (306 µmol/L)
BIBLIOGRAPHY
1.Hijmans Van den Bergh A.A., Muller P., Biochem,
77,(1916),90.
2.Walters M.I., Gerarde R.W., Microchem, 15, (1970), 231.
Lot number
Manufacturer’ s address
Expiration date
(01/2005)
FTAN-BILI-2

CALCIUM
ARSENAZO
For in vitro diagnostic use only Ref : CALA - 0600 2 x 125 mL
PRINCIPLE Read against reagent blank

At a neutral pH, the Ca2+ forms with arsenazo III a complex,
the color intensity of which is directly proportional to the BLANK STANDARD SAMPLE
concentration of calcium in the sample.
Reagent 1 mL 1 mL 1 mL
REAGENTS COMPOSITION Distilled water 10 µL - -

Standard - 10 µL -
Reagent : R
Sample - - 10 µL
MES, pH 6.50 100 mmol/L
Arsenazo III 200 µmol/L
Standard : Std
Calcium 10 mg/dL
100 mg/L
2.5 mmol/L CALCULATION
OD Sample mg/dL n= 10
STABILITY OF REAGENTS xn mg/L n= 100
OD Standard mmol/L n= 2.5
are stable until the expiry date stated on the label. n = standard concentration.
Take dilution factor into account for the calculation of the

concentration in urine.
OF WORKING REAGENT
The reagent is ready for use.
QUALITY CONTROL
SAMPLES To ensure adequate quality, control sera such as ELITROL I
Serum.
mended.
Urine diluted 1/3 with distilled water ; adjust to pH 3-4 with
HCl N/10.
LINEARITY
REFERENCE VALUES Up to 15 mg/dL (150 mg/L) (3.75 mmol/L).
Serum : 8.8 - 10.2 mg/dL
88 - 102 mg/L Note : The sample size can be increased, in parallel with blank
2.2 - 2.55 mmol/L and standard, up to 25 µL without change of performances.
Urine : 100 - 400 mg/24 h

2.5 - 10 mmol/24 h BIBLIOGRAPHY
Baver, P. J., Anal. Biochem., 110, (1981), 61.
an indication. SYMBOLS USED ON LABELS :
PROCEDURE Lot number

This reagent can be used manually (see method below) and Consult instruction for use
on most analysers.
The applications are available on request. In vitro diagnostic medical device
Wavelength : 650 nm (600 nm) Manufacturer’ s address
Temperature : 37°C
Cuvette : 1 cm light path Temperature limitation
Expiration date
(01/2005)
FTAN-CALA-3

CALCIUM
OCPC
For in vitro diagnostic use only Ref : CALO - 0600 2 x 125 mL
PRINCIPLE PROCEDURE
Colorimetric measurement with ortho-cresolphtalein complexon. This reagent is designed for use with manual method and
The 8-hydroxyquinoline prevents Mg2+ from interference up to commercially available automated analysers but it must be
4 mmol/L (100 mg/L). used only in the one-procedure reagent (with the reagent
containers tightly sealed ). Refer to the application sheet for
REAGENTS COMPOSITION instructions and specifications for use automated analysers.
Reagent 1 : R1 Wavelength : 570 nm

Diethylamine 360 mmol/L Temperature : 37°C
Reagent 2 : R2 Cuvette : 1 cm light path
O-Cresolphtalein complexon 0.15 mmol/L
8-Hydroxyquinoline 17.2 mmol/L BLANK STANDARD SAMPLE
Standard : Std
W. Reagent 1 mL 1 mL 1 mL
Calcium 10 mg/dL
100 mg/L Distilled water 10 µL - -
2.5 mmol/L Standard - 10 µL -
Sample - - 10 µL
PRECAUTIONS
The reagent is very sensitive to atmospheric CO2, keep the vial
tightly sealed after use.
IRRITANT! The reagent 1 contains the diethylamine (3.75 %) Mix and read the optical density (OD) after a 5 minute incubation.
and the reagent 2 contains the dimethylsulfoxide (36 %). The final colour is stable for at least 1 hour.
Irritant for the eyes , the respiratory system and skin.
CALCULATION
STABILITY OF REAGENTS OD Sample mg/dL n= 10
When stored at 2-8° C and protected from light, the reagents xn mg/L n= 100
and the standard are stable until the expiry date stated on the OD Standard mmol/L n= 2.5
label.
n = standard concentration.
PREPARATION AND STABILITY Take dilution factor into account for the calculation of the
OF WORKING REAGENT concentration in urine.
Mix 1 volume of the reagent 1 with 1 volume of the reagent 2.
Stability : 4 hours at 20-25°C )QUALITY CONTROL
20 hours at 2-8°C To ensure adequate quality, control sera such as ELITROL I
SAMPLES mended.
Serum.
Urine diluted 1/3 with distilled water ; adjust to pH 3-4 with )PERFORMANCE DATA
HCl N/10.
analyser (37°C)
REFERENCE VALUES
Serum : 8.8 - 10.2 mg/dL - Linearity
88 - 102 mg/L The reagent is linear up to 13.5 mg/dL (135 mg/L, 3.40
2.2 - 2.55 mmol/L mmol/L).
Urine : 100 - 400 mg/24 h
2.5 - 10 mmol/24 h - Detection limit
)Note : It is recommended for each laboratory to establish and equal to 0.54 mg/dL (5.40 mg/L ).
maintain its own reference values. The given data here are only .../...
an indication.
(08/2004)
FTAN-CALO-2

CALCIUM
OCPC
- Precision
Within-Run
Normal Level :
n = 20 SD = 2.65 CV = 2.74 %
Pathological level :
n = 20 SD = 3.66 CV = 2.58 %
Between-run:
Normal Level :
n = 20 SD = 3.19 CV = 3.42 %
Pathological level :
n = 20 SD = 6.88 CV = 5.11 %
)INTERFERENCES
According to SFBC recommendations, some studies have been
performed to determine the level of interference from different
component :
Bilirubin : No significant interference up to 35 mg/dL
(350 mg/dL)
Haemoglobin : No significant interference up to 2 g/L
(200 mg/L)
Ascorbic Acid : No significant interference up to
40 mg/dL (400 mg/L)
Magnesium : No significant interference up to 100 mg/L
Turbidity : No significant interference up to1000 mg/dL
Triglycerides equivalent (10 g/L)
Cholesterol : No significant interference up to 0.6 g/dL
(6 g/L)
BIBLIOGRAPHY
1.Connerty H.V., Briges A.R., Am. J. Clin. Path, 45, (1966),
290.
2.Cowley B. and al., Clin. Chem., 32, (1986), 894.
3. Corns, C. and Ludman C., Anal. Clin. Biochem., 24, (1987)
345.
4.Vassault, A. Grafmeyer, D. Naudin, et al., Protocole de vali-
dation de techniques. (Document B, stade 3) Ann. Biol. Clin.,
(1986), 44, 686.
SYMBOLS USED ON LABELS:
Lot Number
Manufacturer’s address
Expiration date
(08/2004)
FTAN-CALO-2

CHLORIDE
For in vitro diagnostic use only Ref : CHLO-0600 2 x 125 mL
PRINCIPLE PROCEDURE
Chloride ions form a coloured complex when reacting with This reagent can be used manually (see method below) and
mercury (II) thiocyanate solution, the intensity of the colour is on most analysers.
proportional to the chloride concentration. The applications are available on request.
Reagent : R Temperature : 25°C, 30°C, 37°C
Mercury (II) thiocyanate 2 mmol/L
Iron (III) Nitrate 20 mmol/L Read against reagent blank.
Nitric acid 29 mmol/L
Standard : Std BLANK STANDARD SAMPLE
Chloride 355 mg/dL
100 mEq/L
100 mmol/L Distilled water 10 µL - -
STABILITY OF REAGENTS Standard - 10 µL -
When stored at 20-25° C and protected from light, the reagents Sample - - 10 µL
PREPARATION AND STABILITY Mix and read the optical density (OD) after a 5 minute incuba-
OF WORKING REAGENT tion.
The reagent is ready for use. The final colour is stable for at least 1 hour.
SAMPLES
CALCULATION
Serum.
Heparin plasma. xn mEq/L n= 100
Urine. OD Standard mmol/L n= 100
REFERENCE VALUES n = standard concentration.

Serum, plasma : 348 - 380 mg/dL
98 - 107 mEq/L
QUALITY CONTROL
98 - 107 mmol/L
Urine : 3900 - 8870 mg/24 h
110 - 250 mEq/24 h mended.

LINEARITY
maintain its own reference values. The given data here are only
an indication. Up to 461.5 mg/dL (130 mEq/L) (130 mmol/L).
BIBLIOGRAPHY
Schoenfeld R.G. and al., Clin. Chem., 10, (1964), 533.
Lot number
Expiration date (01/2005)

FTAN-CHLO-2

CHOLESTEROL SL
Ref.: CHSL - 0490 1 x 100 mL

Ref.: CHSL - 0500 6 x 100 mL
Ref.: CHSL - 0700 4 x 250 mL
CLINICAL SIGNIFICANCE (1-2) WORKING REAGENT

Cholesterol is both coming from food and synthesized by the The reagent is ready for use.
human body, mainly in hepatic and intestinal cells.
Cholesterol is a component of cells and organoïds membranes. SAMPLES (4)
It is a metabolic precursor of bile acids, vitamin D and steroid - Specimen
hormones. Cholesterol, insoluble molecule, circulates associe- Serum.
ted with lipoproteins (HDL, LDL and VLDL). Heparin or EDTA plasma from fasting patients.
Quantification of total cholesterol allows the detection of
hypercholesterolemia, isolated or associated with hypertrigly- - Storage
ceridemia. High cholesterol concentrations are associated Samples are stable 5 to 7 days if stored at 4°C, 3 months at
with a high risk for vascular accident and apparition of athe- -20°C and several years at -70°C.
rosclerosis. The LDL/HDL ratio should be taken in considera-
tion for evaluating the risk of developping cardiovascular
diseases.
The NCEP (American National Cholesterol Education Program)
has established the following classification for serum total
METHOD (3)
cholesterol levels according to the risk of developing coronary
Enzymatic - colorimetric.
heart diseases:
Trinder. End point.
Normal < 200 mg/dL (5.18 mmol/L)
PRINCIPLE (3) Borderline high 200-240 mg/dL (5.18 - 6.19 mmol/L)
High ≥ 240 mg/dL (6.22 mmol/L)
Enzymatic determination of total cholesterol according to the
following reactions :
Cholesterol esterase
Cholesterol ester + H2O Cholesterol + Fatty acids maintain its own reference values. The data given here are only
an indication.
Cholesterol oxidase
Cholesterol + O2 Cholest-4-en-3-one + H202
)PROCEDURE
Peroxidase The reagent can be used on most analysers. The applications
2H2O2 + Phenol + 4-AAP Quinoneimine + 4H2O are available on request.
4-AAP = Amino-4-antipyrine Wavelength : 500 nm

Temperature : 37°C
REAGENTS COMPOSITION Read against reagent blank.
Reagent : R BLANK STANDARD SAMPLE
Pipes buffer, pH 6.7 50 mmol/L
Working reagent 300 µL 300 µL 300 µL
Phenol 24 mmol/L
Sodium cholate 5 mmol/L Distilled water 3 µL
4-Aminoantipyrine 0.5 mmol/L Standard 3 µL
Cholesterol esterase ≥ 180 U/L Sample 3 µL
Cholesterol oxidase ≥ 200 U/L
Peroxidase ≥ 1000 U/L Mix and read the absorbances (A) after a 325 seconds incu-
bation.
PRECAUTIONS The final colour is stable for at least 1 hour.
- The reagent contains less than 0.1 % sodium azide. Sodium
azide can react with copper and lead plumbing to form explo-
sive metal azides.
CALCULATION
Regulations currently in use regarding dangerous waste elimi- Asample
nation must be respected. If discharge in the canalisations, xn n = standard concentration
rinse with plenty of water. Astandard
- Use clean or single use laboratory equipment only to avoid
contaminations. CALIBRATION
On Cobas Mira, calibration must be performed at least every
STABILITY OF REAGENTS 2 weeks, and after each change of batch, or quality control
When stored at 2-8° C and protected from light, the reagent is results.
stable until the expiry date stated on the label. .../...
(01//2005)
FTAN-CHSL-6

CHOLESTEROL SL
QUALITY CONTROL Total bilirubin: No significant interference up to 30 mg/dL

To ensure adequate quality, control sera such as ELITROL I (300 mg/L, 510 µmol/L)
(normal control) and ELITROL II (abnormal control) are recom- Conjugated bilirubin: No significant interference up to 25
mended. mg/dL (250 mg/L, 430 µmol/L).
PERFORMANCE DATA
The following data were obtained using the COBAS MIRA BIBLIOGRAPHY
analyser (37°C) 1.Rifai, N., et al., Lipids, Lipoproteins, and Apolipoproteins.
Tietz Fundamentals of Clinical Chemistry, 5th Ed., Burtis,
- Analytical range C.A. & Ashwood, E.R. (W.B. Saunders eds. Philadelphia USA),
The reagent is linear from 20 to 600 mg/dL (0.2 to 6 g/L, (2001), 463.
0.5 to 15.5 mmol/L). 2. Naito, H.K., Coronary Artery Disease and Disorders of Lipid
Metabolism. Clinical Chemistry: Theory, Analysis, Correlation,
4th Ed., Kaplan, L.A., Pesce, A.J., Kazmierczak, S.C. (Mosby,
Determined according to SFBC protocol, the detection limit is Inc. eds. St Louis USA), (2003), 603.
equal to 5 mg/dL (0.05 g/L, 0.13 mmol/L). 3.Allain, C.C., et al., Enzymatic determination of total serum
cholesterol. Clin. Chem., (1974), 20, 470.
- Sensitivity 4.Tietz, N.W. Clinical guide to laboratory tests, 3rd Ed., (W.B.
The average variation of the analytical signal is 1.53 × 10-3 ∆A Saunders eds. Philadelphia USA), (1995), 130.
per mg/dL of cholesterol (or 153 × 10-3 ∆A per g/L, 0.39 ∆A 5.Expert Panel on Detection, Evaluation, and Treatment of
per mmol/L) for a light path of 1 cm. High Blood Cholesterol in Adults (Adult Treatment Panel III),
Executive Summary of the Third Report of the National
- Precision Cholesterol Education Program (NCEP). JAMA, (2001), 285,
2486.
6.Vassault, A., et al., Protocole de validation de techniques,
Low level : n = 20 m = 117 mg/dL CV = 1,7 % (Document B, stade 3). Ann. Biol. Clin., (1986), 44, 686.
Medium level : n = 20 m = 181 mg/dL CV = 1,3 %
High level : n = 19 m = 283 mg/dL CV = 1,4 % SYMBOLS USED ON LABELS :
Between-run reproducibility Lot number

Low level : n = 89 m = 123 mg/dL CV = 3,8 %
Medium level : n = 89 m = 195 mg/dL CV = 3,8 % Consult instruction for use
High level : n = 87 m = 297 mg/dL CV = 3,9 % In vitro diagnostic medical device
- Correlation Manufacturer’s address

A comparative study has been performed between Elitech
method and another commercial reagent on 86 human serum Expiration date
samples ranging from 20 to 560 mg/dL. The parameters of
linear regression are as follows : Temperature limitation
Correlation coefficient (r) : 0.9995
Linear regression : y = 1.0095 x + 1.6 mg/dL
- Interferences (6)
According to SFBC recommendations, studies have been per-

formed to determine the level of interference from different
compounds:
Haemoglobin: No significant interference up to 0.4 g/dL (4
g/L).
Ascorbic acid: No significant interference up to 5 mg/dL (50
mg/L, 0.28 mmol/L).
Turbidity No significant interference up to 600 mg/dL
Triglyceride equivalent ( 6 g/L, 6.9 mmol/L)
Glucose: No significant interference up to 0.5 g/dL (5 g/L, 30 (01/2005)
mmol/L). FTAN-CHSL-6

CHOLESTEROL
Ref : CHOL - 0220 12 x 20 mL

Ref : CHOL - 0420 9 x 50 mL
Ref : CHOL - 0520 6 x 100 mL
For in vitro diagnostic use only Ref : CHOL - 0720 4 x 250 mL

Enzymatic colorimetric determination of total cholesterol maintain its own reference values. The given data here are only
according to the following reactions : an indication.
Cholesterol esterase
Cholesterol ester + H2O Cholesterol + Fatty acids PROCEDURE
Cholesterol oxidase This reagent can be used manually (see method below) and
Cholesterol + O2 4-Cholesten-3-one + H202 on most analysers.
Peroxidase
2H2O2 + Phenol + 4-Aminoantipyrine Red quinone + Wavelength : 500 nm (492-550)
4H2O Temperature : 37°C
REAGENTS COMPOSITION Read against reagent blank.
Reagent 1 : R1 BLANK STANDARD SAMPLE

Phenol 24 mmol/L Working Reagent 1 mL 1 mL 1 mL
Sodium cholate 0.5 mmol/L Distilled water 10 µL - -
Reagent 2 : R2 Standard - 10 µL -
Cholesterol esterase ≥ 200 U/L Sample - - 10 µL
Cholesterol oxidase ≥ 250 U/L
Peroxidase ≥ 1000 U/L Mix and read the optical density (OD) after a 5 minute incuba-
4-Aminoantipyrine 0.5 mmol/L tion.
Standard : Std The final colour is stable for at least 1 hour.
Cholesterol 200 mg/dL
CALCULATION
2 g/L
5.17 mmol/L
xn g/L n= 2
PRECAUTIONS
The reagent 1 contains less than 0.1 % sodium azide. n = standard concentration.
STABILITY OF REAGENTS QUALITY CONTROL

mended.
PREPARATION AND STABILITY LINEARITY

OF WORKING REAGENTS Up to 500 mg/dL (5 g/L) (12.9 mmol/L).
BIBLIOGRAPHY
Stability : 3 weeks at 20-25°C
Allain C.C and al., Clin. Chem., 20, (1974), 470.
3 months at 2-8°C
SAMPLES
Serum. Lot Number
Heparin plasma.
REFERENCE VALUES In vitro diagnostic medical device

150 - 260 mg/dL
1.50 - 2.60 g/L Manufacturer’s address
3.87 - 6.71 mmol/L Temperature limitation
(01/2005)
Expiration date FTAN-CHOL-2

CHOLESTEROL LDL
DIRECT SL

Ref.: LDLD - 0345 1 x 45 mL
CLINICAL SIGNIFICANCE (1-4) PRECAUTIONS

- Reagent R2 contains less than 0.1 % sodium azide. Sodium azide
Cholesterol, insoluble molecule, circulates associated with can react with copper and lead plumbing to form explosive metal
lipoproteins (HDL, LDL and VLDL). LDL (Low Density azides. Regulations currently in use regarding dangerous waste
Lipoprotein) come from VLDL (Very Low Density Lipoprotein) elimination must be respected. If discharge in the canalisations,
hydrolysis by different lipolitic enzymes. LDL, which transport rinse with plenty of water.
approximatively 60% of total plasmatic cholesterol, are mainly - Use clean or single use laboratory equipment only to avoid
taken up through specific receptors by extrahepatic and hepa- contaminations.
tic tissues.
A positive association exists between the incidence of coronary STABILITY OF REAGENTS
heart disease and LDL cholesterol. LDL are atherogen lipopro-
When stored at 2-8°C and protected from light, the reagents are
teins: LDL cholesterol increase is a major cause of apparition
and evolution of atherosclerosis, in particular coronary athe-
rosclerosis. Therefore, the treatment of elevated LDL choleste-
rol is the primary target of cholesterol-lowering therapy.
An increase in LDL cholesterol may be seen in different patho- OF WORKING REAGENT
logical states including hyperlipoproteinemia types IIa and IIb, Reagents R1 and R2 are ready for use.
premature coronary heart diseases, hyperlipoproteinemia due
to hepatic or renal disorder, to hypothyroidism, diabetes. SAMPLES
- Specimen
METHOD Serum from fasting patient.
Enzymatic. Colorimetric.
End point. - Storage
Store sera at 4°C before analysis.
Sera are stable 1 to 3 days at 4°C. For longer storage, freeze them
PRINCIPLE at -70°C.
1th step:
When a sample is mixed with reagent R1, the protecting agent REFERENCE VALUES (4)
binds to LDL and protecting it from enzyme reaction:
CHE + CO
Non-LDL lipoproteins + O2 Cholest-4-en-3-one + H2O2 has established the following classification for serum LDL cho-
Catalase lesterol levels according to the risk of developing coronary
2H2O2 2H2O + O2 heart disease:
Optimal < 100 mg/dL (2.6 mmol/L)
2nd step: Near or above optimal 100-129 mg/dL (2.6 - 3.3 mmol/L)
When reagent R2 is added, LDL is released and catalase is Borderline high 130-159 mg/dL (3.4 - 4.1 mmol/L)
inactivated by sodium azide: High 160-189 mg/dL (4.1 - 4.9 mmol/L)
CHE + CO Very High ≥ 190 mg/dL (4.9 mmol/L)
Cholesterol LDL + O2 Cholest-4-en-3-one + H2O2
Peroxidase Note : It is recommended for each laboratory to establish and

2H2O2 + 4-AA + HDAOS Blue complex + 4H2O maintain its own reference values. The data given here are only an
indication.
CHE = Cholesterol esterase
CO = Cholesterol oxidase PROCEDURE
4-AA = 4-Aminoantipyrine These reagents can be used on most analysers. The applications
HDAOS = N-(2-Hydroxy-3-sulfopropyl)-3,5-dimethoxyaniline are available on request.
Wavelength : 600 nm
REAGENTS COMPOSITION Temperature : 37°C
Reagent 1 : R1 Read against reagent blank.
Good’s Buffer, pH 6,8 25 mmol/L BLANK CALIBRATOR SAMPLE
HDAOS 0.64 mmol/L Reagent R1 270 µL 270 µL 270 µL
Cholesterol esterase 5 000 U/L Distilled water 3 µL - -
Cholesterol oxidase 5 000 U/L Calibrator - 3 µL -
Catalase 1 000 000 U/L Sample - - 3 µL
Protecting agent
Mix and after 5 minutes incubation, measure the absorbance (A1),
then add:
Reagent 2 : R2
Good’s Buffer, pH 7,0 25 mmol/L Reagent R2 90 µL
4-Aminoantipyrine 3.4 mmol/L
Peroxidase 20 000 U/L Mix and after 5 minutes incubation, measure the absorbance (A2).
Deprotecting agent .../...
(03/2005)
FTAN-LDLD-3

CHOLESTEROL LDL
DIRECT SL
CALCULATION Turbidity: No significant interference up to 600 mg/dL

Triglycerides equivalent (6 g/L, 6.9 µmol/L).
(A2 - A1)sample
xn n = calibrator concentration Hemoglobin: No significant interference up to 500 mg/dL (5 g/L).
(A2 - A1)calibrator
Note:
CALIBRATION 1. Samples with triglycerides concentrations exceeding 600 mg/dL
ELITECH Cholesterol LDL Calibrator should be used for calibra- (6 g/L, 6.9 µmol/L) should be diluted with saline solution before
tion. It is sold separately with the reference LDLD-0010 (4 x 1mL). analysis.
2. Artificial lipid mixture, as contained in some solutions for intra-
QUALITY CONTROL venous infusion can interfer with this test principle. Samples from
To ensure adequate quality, control sera are recommended. patients currently under such treatment are to be excluded from
determination with this reagent.
3. LDL cholesterol value of patients with hyperlipoproteinimia Type
PERFORMANCE DATA
III must not be determined with this method.(7)
ser (37°C).
BIBLIOGRAPHY
- Analytical range
1.Rifai, N., Bachorik, P.S., Albers, J.J., Lipids, Lipoproteins, and
The reagent is linear from 20 to 320 mg/dL (0.2-3.2 g/L, 0.5-8.3
mmol/L). Apolipoproteins. Tietz Fundamentals of Clinical Chemistry, 5th
Ed., Burtis, C.A. & Ashwood, E.R. (W.B. Saunders eds.
Philadelphia USA), (2001), 463.
- Detection limit (5) 2.Naito, H.K., Coronary artery disease and disorders of lipid meta-
Determined according to SFBC protocol, the detection limit is bolism, Clinical Chemistry: Concepts and Application, Anderson,
equal to 2.0 mg/dL (20 mg/L, 0.05 mmol/L). S.C., Cockayne, S. (W.B. Saunders eds. Philadelphia USA), (2003),
603.
- Sensitivity
3.Tietz, N.W., Clinical guide to laboratory tests, 3rd Ed., (W.B.
The average variation of the analytical signal is 1.60 m∆A per
mg/dL of LDL cholesterol (160 m∆A per g/L, 62 m∆A per mmol/L)
for a light path of 1 cm. 4.Expert Panel on Detection, Evaluation, and Treatment of High
Blood Cholesterol in Adults (Adult Treatment Panel III), Executive
Summary of the Third Report of the National Cholesterol Education
- Precision Program (NCEP). JAMA, (2001), 285, 2486.
Within-run reproducibility: 5.Vassault A., et al., Protocole de validation de techniques,
Low level : n = 20 m = 101 mg/dL CV = 0.8 % (Document B, stade 3). Ann. Biol. Clin., (1986), 44, 686.
Medium level : n = 20 m = 127 mg/dL CV = 0.5 % 6.Vassault A., et al., Analyses de biologie médicale: spécifications
High level : n = 20 m = 164 mg/dL CV = 0.6 % et normes d’acceptabilité à l’usage de la validation des techniques.
Ann. Biol. Clin., (1999), 57, 685.
Between-run reproducibility: 7.Esteban-Salan, M., et al, Analytical and clinical evaluation of two
Low level : n = 80 m = 103 mg/dL CV = 2.1 % homogeneous assay for LDL-Cholesterol in hyperlipidemic patients.
Medium level : n = 80 m = 130 mg/dL CV = 2.3 % Clin Chem, 2000, 46, 1121.
High level : n = 80 m = 167 mg/dL CV = 2.1 %
- Correlation SYMBOLS USED ON LABELS :

and another commercial reagent on 64 human sera. The sample
Lot number
concentrations ranged from 20 to 350 mg/dL.
The parameters of linear regression are as follows : Consult instruction for use
Linear regression : y = 0.8775 x + 12 mg/dL In vitro diagnostic medical device
- Interferences (5,6) Manufacturer’s address

According to SFBC recommendations, studies have been perfor-
med to determine the level of interference from different com- Expiration date
pounds:
Conjugated Bilirubin: No significant interference up to 25 mg/dL Temperature limitation
(250 mg/L, 430 µmol/L).
Unconjugated Bilirubin: No significant interference up to 35
mg/dL (350 mg/L, 600 µmol/L).
(03/2005)
FTAN-LDLD-3

CHOLESTEROL HDL
DIRECT SL
Ref.: HDLD - 0360 1 x 60 mL

For in vitro diagnostic use only Ref.: HDLD - 0370 3 x 60 mL
CLINICAL SIGNIFICANCE (1-4) )PRECAUTIONS

Cholesterol is a lipidic molecule, insoluble in aqueous medium - Reagent R1 contains a mixture of 5-chloro-2-methyl-4-isothiazo-
as plasma, in which it circulates in form of pseudo-emulsion: lin-3-one and 2-methyl-4-isothiazolin-3-one. The reagent R1 is
association of lipids and proteins constituting lipoproteins. irritant (Xi).
These lipoproteins vary quantitatively and qualitatively in their R 43 : May cause sensitisation by skin contact.
lipidic and proteic composition, inducing structural but such S 24: Avoid contact with skin.
a functional difference to them. The most used classification S 37: Wear suitable gloves.
is that which is based on their difference in density. This - Use clean or single use laboratory equipment only to avoid conta-
explains the name of High Density Lipoprotein (HDL), Low minations.
Density Lipoprotein (LDL), Very Low Density Lipoprotein - Do not freeze reagents.
(VLDL) and the existence of many intermediate fractions which
correspond to all the stages of the lipidic metabolism. HDL STABILITY OF REAGENTS
(lipoproteins of high density) contain approximately 50 % of When stored at 2-8°C and protected from light, the reagents are
lipids including 20 % of cholesterol. The HDL molecule plays stable until the expiry date stated on the label.
an integral role in removing cellular cholesterol and thus cel-
lular purification. Many epidemiologic studies confirmed the
PREPARATION AND STABILITY OF WORKING REAGENT
Reagents are ready for use.
anti-atherogen fonction of this fraction leading to the concept
of "good cholesterol". Cholesterol HDL represents consequently
an element of evaluation of the atherogenesis risk when there SAMPLES (2-3)
is an imbalance of the ratios cholesterol total/cholesterol HDL - Specimen
or cholesterol LDL/cholesterol HDL. Serum from fasting patient.
METHOD - Storage
Immunoinhibition. Store sera at 4°C before analysis.
Sera are stable 1 to 3 days at 4°C. For longer storage, freeze them
Colorimetric. End point.
at -50°C.
PRINCIPLE
Anti human β-lipoprotein antibody in reagent R1 binds to lipo-
proteins (LDL, VLDL and chylomicrons) other than HDL. The The NCEP (American National Cholesterol Education Program)
antigen-antibody complexes formed block enzyme reactions has established the following classification for serum LDL cho-
when reagent R2 is added. Cholesterol esterase and choleste- lesterol levels according to the risk of developing coronary
rol oxidase in reagent R2 react only with HDL-C. Hydrogen heart disease:
peroxide produced by the enzyme reactions with HDL-C yields High < 40 mg/dL (1.04 mmol/L)
a blue colour complex upon oxidative condensation of F-DAOS Low ≥ 60 mg/dL (1.55 mmol/L)
(N-ethyl-N-(2-hydroxy-3-sulfopropyl)-3,5-dimethoxy-4-fluo-
roaniline, sodium salt) and 4-aminoantipyrine in the presence Note : It is recommended for each laboratory to establish and
of peroxidase. maintain its own reference values. The data given here are only an
By measuring the absorbance of the blue colour complex pro- indication.
duced, at the average wavelength of 600 nm, the HDLC
concentration in the sample can be calculated when compared )PROCEDURE
with the absorbance of the HDL-C Calibrator. These reagents can be used on most analysers. The applications
are available on request.
Reagent 1 : R1 Temperature : 37°C
Good’s buffer, pH 7.0 30 mmol/L Read against reagent blank.
4-Aminoantipyrine 0.9 mmol/L BLANK CALIBRATOR SAMPLE
Peroxidase 2400 U/L Reagent R1 240 µL 240 µL 240 µL
Ascorbate oxidase 2700 U/L Distilled water 2.5 µL - -
Anti human β-lipoprotein antibody Calibrator - 2.5 µL -
Sample - - 2.5 µL
Reagent 2 : R2 Mix and after 4 minutes incubation, measure the absorbance (A1),
Good’s buffer, pH 7.0 30 mmol/L then add:
Cholesterol esterase 4000 U/L Reagent R2 60 µL
Cholesterol oxidase 20000 U/L
F-DAOS 0.8 mmol/L Mix and after 5 minutes incubation, measure the absorbance (A2).
.../...
(03/2005)
FTAN-HDLD-3

CHOLESTEROL HDL
DIRECT SL
CALCULATION Turbidity: No significant interference up to 600 mg/dL

(A2 - A1)sample Triglycerides equivalent (6 g/L, 6.9 µmol/L).
xn n = calibrator concentration Hemoglobin: No significant interference up to 500 mg/dL (5 g/L).
(A2 - A1)calibrator
CALIBRATION BIBLIOGRAPHY
ELITECH Cholesterol HDL Calibrator should be used for calibra-
1. Rifai, N., Bachorik, P.S., Albers, J.J., Lipids, Lipoproteins, and
tion. It is sold separately with the reference HDLD-0025 (1 x 3 mL)
or HDLD-0030 (4 x 3 mL). Apolipoproteins. Tietz Fundamentals of Clinical Chemistry, 5th
Ed., Burtis, C.A. & Ashwood, E.R. (W.B. Saunders eds.
QUALITY CONTROL Philadelphia USA), (2001), 463.
To ensure adequate quality, control sera are recommended. 2. Naito, H.K., Coronary artery disease and disorders of lipid meta-
bolism, Clinical Chemistry: Concepts and Application, Anderson,
S.C., Cockayne, S. (W.B. Saunders eds. Philadelphia USA), (2003),
)PERFORMANCE DATA (37°C) 603.
ser (37°C). 3. Tietz, N.W., Clinical guide to laboratory tests, 3rd Ed., (W.B.
- Analytical range 4. Expert Panel on Detection, Evaluation, and Treatment of High
The reagent is linear from 8 to 180 mg/dL (0.08-1.8 g/L, 0.2-4.7 Blood Cholesterol in Adults (Adult Treatment Panel III), Executive
mmol/L). Summary of the Third Report of the National Cholesterol Education
Program (NCEP). JAMA, (2001), 285, 2486.
- Detection limit (5) 5. Vassault A., et al., Protocole de validation de techniques,
Determined according to SFBC protocol, the detection limit is (Document B, stade 3). Ann. Biol. Clin., (1986), 44, 686.
equal to 1.0 mg/dL (10 mg/L, 0.026 mmol/L). 6. Vassault A., et al., Analyses de biologie médicale: spécifications
et normes d’acceptabilité à l’usage de la validation des techniques.
- Sensitivity Ann. Biol. Clin., (1999), 57, 685.
The average variation of the analytical signal is 3.46 m∆A per
mg/dL of HDL cholesterol (346 m∆A per g/L, 134 m∆A per SYMBOLS USED ON LABELS :
mmol/L) for a light path of 1 cm.
Lot number
- Precision
Within-run reproducibility: Consult instruction for use
Low level : n = 20 m = 39 mg/dL CV = 1.6 %
Medium level : n = 20 m = 54 mg/dL CV = 1.4 % In vitro diagnostic medical device
Between-run reproducibility:
Low level : n = 20 m = 31 mg/dL CV = 3.5 % Expiration date
Medium level : n = 20 m = 55 mg/dL CV = 3.7 %
High level : n = 20 m = 80 mg/dL CV = 3.4 % Temperature limitation
- Correlation
on COBAS MIRA and a method validated on another analyser on
60 human sera. The sample concentrations ranged from 8 to 167
mg/dL.
The parameters of linear regression are as follows :
Linear regression : y = 1.0367 x - 3 mg/dL
- Interferences (5,6)
According to SFBC recommendations, studies have been perfor-
med to determine the level of interference from different com-
pounds:
Conjugated Bilirubin: No significant interference up to 25 mg/dL
(250 mg/L, 430 µmol/L).
Unconjugated Bilirubin: No significant interference up to 35
(03/2005)
FTAN-HDLD-3

HDL CHOLESTEROL
Ref : HDLC - 0060 3 x 10 mL

For in vitro diagnostic use only Ref : HDLC - 0520 3 x 100 mL
PRINCIPLE Mix, wait for 10 minutes and centrifuge at 5 000 r.p.m. for 15
Chylomicrons, Very Low Density Lipoproteins (VLDL) and Low minutes.
Density Lipoproteins (LDL) of serum are precipitated by The supernatant is collected for HDL determination.
Phosphotungstic acid and Magnesium ions. 2) HDL determination :
After centrifugation, High Density Lipoproteins (HDL) are in the The cholesterol PAP kit is used for HDL cholesterol determination
supernatant. Cholesterol included in this phase, is measured by (refer to insert technical data sheet for instruction about prepara-
an enzymatic method. tion of cholesterol reagent).
REAGENTS COMPOSITION This reagent can be used manually (see method below) and on
most analysers.
Reagent 1 : R1
Phosphotungstic acid 14 mmol/L
Wavelength : 500 nm (492-550)
Reagent 2 : R2
Temperature : 37°C
Magnesium chloride 1 mol/L Cuvette : 1 cm light path
Standard : Std Read against reagent blank.
0.50 g/L BLANK STANDARD SAMPLE
1.30 mmol/L
Additional reagent : Cholesterol Reagent 1 mL 1 mL 1 mL
Kit for Cholesterol determination.
Distilled water 50 µL - -
STABILITY OF REAGENTS Standard 50 mg/dL - 50 µL -
When stored at 2-8° C and protected from light, the reagents are Supernatant - - 50 µL
PREPARATION AND STABILITY The final colour is stable for at least 1 hour.
OF PRECIPITATING REAGENT
CALCULATION
Mix 4 volumes of the reagent 1 with 1 volume of the reagent 2.
Stability : 6 weeks at 20-25°C x n x 1.1* g/L n= 0.50
SAMPLES
n = standard concentration
Serum.
Heparin plasma. *1.1 = dilution factor of the sample.
No interference due to Triglycerides up to 0.4 g/dL and Cholesterol

up to 0.6 g/dL.
QUALITY CONTROL
To ensure adequate quality, control sera are recommended.
REFERENCE VALUES
BIBLIOGRAPHY
Good Standard Increased 1.Fruchart J.C., Rev. Fr. des laboratoires, 103, (1982), 7.
prognosis risk risk 2.Lopes-Virella M.F. and al., Clin. Chem., 23, (1977), 882.
> 55 mg/dL 35 - 55 mg/dL < 35 mg/dL 3.Burstein M. and al., J. of Lipid Res., 11, (1970), 583.
Male > 0.55 g/L 0.35 - 0.55 g/L < 0.35 g/L
> 1.4 mmol/L 0.9 - 1.4 mmol/L < 0.9 mmol/L SYMBOLS USED ON LABELS:
> 65 mg/dL 45 - 65 mg/dL < 45 mg/dL Lot Number

Female > 0.65 g/L 0.45 - 0.65 g/L < 0.45 g/L
> 1.7 mmol/L 1.2 - 1.7 mmol/L < 1.2 mmol/L Consult instruction for use
Note : It is recommended for each laboratory to establish and main- In vitro diagnostic medical device
tain its own reference values. The given data here are only an indi-
cation.
PROCEDURE Temperature limitation
1) Sample preparation : Expiration date

Add to 500 µL of sample, 50 µL of precipitating reagent. (01/2005)
FTAN-HDLC-3

CHOLINESTERASE
Ref : CHES - 0053 16 x 3 mL

For in vitro diagnostic use only Ref : CHES - 0300 4 x 30 mL
METHOD PROCEDURE
Enzymatic Wavelength : 405 nm (400-440)
Kinetic Temperature : 25° C, 30° C
PRINCIPLE Read against distilled water.
Cholinesterase
Butyrylthiocholine + H20 Thiocholine + Butyrate
Working reagent 1 : 3.0 mL
Sample : 20 µL
Thiocholine+5,-5’-Dithio-bis- 2-Nitrobenzoate-5-mercaptothio -
Working reagent 2 : 100 µL
(2-nitrobenzoate) choline + 5-Thio-2-nitrobenzoate
Mix and measure the change of optical density (∆OD) every 30
seconds (∆OD/30 sec.) during 90 seconds.
CALCULATION
Reagent 1 : R1
Phosphate buffer, pH 7.40 52 mmol/L
Activity (U/L) = ∆OD/30 sec. x 23 460
5,-5’-Dithiobis-2-nitrobenzoic acid 0. 24 mmol/L
Reagent 2 : R2 QUALITY CONTROL

S-Butyrylthiocholine iodide 218 mmol/L To ensure adequate quality, control sera such as ELITROL I
(normal control) and ELITROL II (abnormal control) are
PRECAUTIONS recommended.
Use clean or single use glass material only to avoid contamina-
tion.
PERFORMANCE DATA
STABILITY The following data were obtained using the COBAS
When stored at 2-8° C and protected from light, the reagents MIRA analyser (25°C)
are stable until the expiry date stated on the label. - Analytical range
The reagent is linear up to 4600 U/L.
If ∆OD/30 sec. exceeds 0.200 at 405 nm, repeat test using
OF WORKING REAGENTS serum diluted 1/5 with sodium chloride solution (9 g/L) and
multiply result by 5.
Working reagent 1 :
Dissolve the reagent 1 with the suitable volume of distilled
water. - Detection limit
Determined according to Vassault and Coll protocol (1986), the
Stability : 4 weeks at 2-8° C
detection limit is equal to 56 U/L.
10 days at 25°C
Working reagent 2 : - Precision

Dissolve the reagent 2 with the suitable volume of distilled Within-run reproducibility
water. Elitrol N :
n = 20 SD = 11.21 CV = 0.60 %
Stability : 4 weeks at 2-8° C Elitrol P :
10 days at 25°C n = 20 SD = 40.92 CV = 2.60 %
SAMPLES Between-run reproducibility

Serum. Elitrol N :
Heparin plasma.
n = 20 SD = 32.3 CV = 1.70 %
Elitrol P :
REFERENCE VALUES n = 20 SD = 52.4 CV = 3.3 %
25° C 30° C
3 000 - 9 300 U/L 3 700 - 11 500 U/L .../...

maintain its own reference values. The data given here are (04/2004)
only an indication. FTAN-CHES-3

CHOLINESTERASE
- Interferences
According to SFBC recommendations (Vassault and Coll,1986),
studies have been performed to determine the level of interference
from different compounds:
Glucose : No significant interference up to

0.6 g/dL (6 g/L)
Cholesterol : No significant interference up to

0.6 g/dL (6 g/L)
Haemoglobin : No significant interference up to
0.5 g/dL (5 g/L)
Bilirubin : No significant interference up to

10 mg/dL (100 mg/L)
Triglycerides : No significant interference up to

0.5 g/dL (5 g/L)
BIBLIOGRAPHY
Knedel, M., Böttger, R., Eine kinetische Methode zur estimmung
der Aktivität der Pseudocholinesterase. Klin Wochenschr, 45,
(1967),325.
Lot Number
Expiration date
(04/2004)
FTAN-CHES-3

CK NAC SL
Ref : CKSL - 0410 2 x 62.5 mL

For in vitro diagnostic use only Ref : CKSL - 0430 4 x 62.5 mL
PRINCIPLE SAMPLE
Kinetic determination of the creatine kinase based upon IFCC Serum free of hemolysis.
and DGKC recommendations : Heparin plasma.
CK
Creatine phosphate + ADP Creatine + ATP
HK REFERENCE VALUES
ATP + D-Glucose G-6-P + ADP
30° C 37° C
G-6-PDH
G-6-P + NADP+ D-Gluconate-6-phosphate + NADPH + H+ Women : 15-110 U/L 24-170 U/L
Men : 15-130 U/L 24-195 U/L
CK = Creatine kinase
HK = Hexokinase Note : It is recommended for each laboratory to establish and
G-6-P = D-Glucose-6-phosphate maintain its own reference values. The given data here are only
G-6-PDH = Glucose-6-phosphate dehydrogenase an indication.
REAGENT COMPOSITION PROCEDURE

Reagent 1 : R1 This reagent can be used manually (see method below) and
Imidazole , pH 6.7 125 mmol/L on most analysers.
D-Glucose 25 mmol/L The applications are available on request.
N-Acetyl-L-Cysteine 25 mmol/L Wavelength : 340 nm
Magnesium acetate 12.5 mmol/L Temperature : 30° C, 37° C
NADP 2.52 mmol/L
EDTA 2.02 mmol/L
Hexokinase ≥ 6 800 U/L Read against distilled water.
Reagent 2 : R2 • One-reagent procedure
Creatine phosphate 250 mmol/L
ADP 15.2 mmol/L Working reagent : 1 mL
AMP 25 mmol/L
Diadenosine pentaphosphate 103 µmol/L Sample : 40 µL
G-6-PDH ≥ 8 800 U/L
PRECAUTIONS optical density per minute (∆OD/min.) during 3 minutes.
These reagents contain less than 0.1 % sodium azide.
Avoid contamination by using clean laboratory material
(pipette, plastic vial for analysers,...).
Discard cloudy reagent. Reagent 1 : 1 mL
Sample : 50 µL
STABILITY OF REAGENT
Mix and wait 3 minutes
Reagent 2 : 250 µL
OF WORKING REAGENT
• One-reagent procedure optical density per minute (∆OD/min.) during 3 minutes.
Mix 4 volumes of reagent 1 with 1 volume of reagent 2.
Stability : 2 days at 20-25° C CALCULATION
2 weeks at 2-8° C • One-reagent procedure
• Two-reagent procedure Activity (U/L) = ∆OD/min. x 4127
Activity (U/L) = ∆OD/min. x 4127
.../...
(01/2005)
FTAN-CKSL-3

CK NAC SL
QUALITY CONTROL
mended.
LINEARITY
result by 10.
BIBLIOGRAPHY
1.Mathieu M. et coll. Recommandation pour la mesure de la
concentration catalytique de la créatinine kinase dans le sérum
humain. Ann. Biol. Clin., 40, (1982), 87.
Lot Number
Expiration date
(01/2005)
FTAN-CKSL-3

CK NAC
Ref : CKNA - 0030 20 x 3 mL

For in vitro diagnostic use only Ref : CKNA - 0200 12 x 20 mL

Kinetic determination of the creatine kinase based upon IFCC 25°C 30°C 37°C
recommendations : Female : 10-70 U/L 15-110 U/L 24-170 U/L
CK Male : 10-80 U/L 15-130 U/L 24-195 U/L

Creatine phosphate + ADP Creatine + ATP
HK Note : It is recommended for each laboratory to establish and

ATP + D-Glucose G-6-P + ADP maintain its own reference values. The given data here are only
an indication.
G-6-PDH
G6P + NADP+ D-Gluconate-6-phosphate +NADPH + H+
PROCEDURE
CK = Creatine kinase
on most analysers.
HK = Hexokinase The applications are available on request.
G-6-P = D-Glucose-6-phosphate Wavelength : 340 nm (334-365)
G-6-PDH = Glucose-6-phosphate dehydrogenase Temperature : 37°C, 30°C, 25°C
Reagent 1 : R1
Imidazole buffer, pH 7.10 100 mmol/L Working reagent 1 : 1 mL
Magnesium acetate 10 mmol/L
Sample : 20 µL
Reagent 2 : R2
N-Acetyl-L-Cysteine 20 mmol/L optical density per minute (∆OD/min.) during 3 minutes.
ADP 2 mmol/L
AMP 5 mmol/L CALCULATION
NADP 2 mmol/L 340 nm : Activity (U/L) = ∆OD/min. x 8 095
D-Glucose 20 mmol/L 334 nm : Activity (U/L) = ∆OD/min. x 8 252
Diadenosine pentaphosphate 10 µmol/L 365 nm : Activity (U/L) = ∆OD/min. x 14 571
EDTA 2 mmol/L
Hexokinase ≥ 3500 U/L QUALITY CONTROL
G-6-PDH ≥ 2000 U/L To ensure adequate quality, control sera such as ELITROL I
Creatine phosphate 30 mmol/L (normal control) and ELITROL II (abnormal control) are recom-
mended.
PRECAUTIONS LINEARITY
The reagent 1 contains less than 0.1 % sodium azide. If ∆OD/min. exceeds 0.150 at 340 nm, repeat test using serum
STABILITY OF REAGENTS result by 10.
When stored at 2-8° C and protected from light, the reagents BIBLIOGRAPHY
Ann. Biol. Clin., 40, (1982), 99.
PREPARATION AND STABILITY SYMBOLS USED ON LABELS:

OF WORKING REAGENT
Dissolve the reagent 2 in the suitable volume of reagent 1. Lot Number
Stability : 24 hours at 20-25°C
7 days at 2-8°C
3 ml reagent stability : 24 hours at 20-25°C In vitro diagnostic medical device
4 days at 2-8°C Manufacturer’s address
SAMPLE Temperature limitation

Serum free of hemolysis. (01/2005)
Expiration date FTAN-CKNA-3

CK-MB SL
Ref : CMSL - 0410 2 x 62.5 mL

Ref : CMSL - 0430 4 x 62.5 mL
PRINCIPLE SAMPLE
The procedure involves measurement of CK activity in the pre- Serum free of hemolysis.
sence of an antibody to CK-M monomer. This antibody com- Heparin plasma.
pletely inhibits the activity of CK-MM and half of the activity of
CK-MB while not affecting the B subunit activity of CK-MB and REFERENCE VALUES
CK-BB. Then we use the CK method to quantitatively determine
30° C 37° C
CK-B activity. The CK-MB activity is obtained by multiplying
0-14 U/L 0-24 U/L
the CK-B activity by two.
The suspicion of myocardial damage is based on the 3 follo-
REAGENT COMPOSITION wing factors :
Total CK 30° C 37° C
Reagent 1 : R1
Female : > 111 U/L > 171 U/L
Imidazole , pH 6.7 125 mmol/L Male : > 131 U/L > 196 U/L
D-Glucose 25 mmol/L CK-MB : > 14 U/L > 25 U/L
N-Acetyl-L-Cysteine 25 mmol/L (CK - MB x 100)
Magnesium acetate 12.5 mmol/L CK-MB ratio : 6-25 %
Total CK
NADP 2.52 mmol/L
EDTA 2.02 mmol/L Note : It is recommended for each laboratory to establish and
Hexokinase ≥ 6 800 U/L maintain its own reference values. The given data here are only
an indication.
Anti-human polyclonal CK-M antibody (sheep) sufficient to
inhibit up to 2 000 U/L of CK-MM.
PROCEDURE
Reagent 2 : R2
on most analysers.
Creatine phosphate 250 mmol/L The applications are available on request.
ADP 15.2 mmol/L
Wavelength : 340 nm
AMP 25 mmol/L Temperature : 30° C, 37° C
Diadenosine pentaphosphate 103 µmol/L Cuvette : 1 cm light path
G-6-PDH ≥ 8 800 U/L
• One-reagent procedure
PRECAUTIONS
Avoid contamination by using clean laboratory material Working reagent : 1 mL
(pipette, plastic vial for analysers,...). Sample : 40 µL
Discard cloudy reagent.
Reagent 1 : 1 mL
PREPARATION AND STABILITY Sample : 50 µL
OF WORKING REAGENT :
• One-reagent procedure Mix and wait 5 minutes
Reagent 2 : 250 µL
Stability : 1 day at 20-25° C
2 weeks at 2-8° C Mix and after a 2 minute incubation, measure the change of
• Two-reagent procedure optical density per minute (∆OD/min.) during 3 minutes.
.../...
(01/2005)
FTAN-CMSL-2

CK-MB SL
CALCULATION
QUALITY CONTROL
To ensure adequate quality, control sera are recommended.
LINEARITY
Inhibition : up to 2 000 U/L of CK-MM at 37° C.
If ∆OD/min. exceeds 0.075 dilute the sample (one part with
nine parts saline solution), repeat the test and multiply the
result by 10.
Linear up at least 600 U/L.
LIMITATION OF THE PROCEDURE

1. The method will also measure any CK-BB isoenzyme pre-
sent in serum. The activity of the isoenzyme is usually negli-
gible, however, if a significant amount of CK-BB activity is
present the CK-MB activity will be overestimated.
2. A macro form of BB (immunoglobulin complexed) has been
observed which will be measured as B in the assay. If the
measured CK-B activity exceeds 20 % of the total CK acti-
vity, the presence of macro BB should be suspected.
BIBLIOGRAPHY
1.Mathieu, M. Recommandations pour la mesure de la
concentration catalytique de la Créatine Kinase dans le sérum
humain à + 30 °C. Documents C et C’. Ann.Biol.Clin. 40,
(1982), 99.
2.Neumeier, D., Prellwitz, W., Würzburg, U. et coll. Deter-
mination of creatine kinase isoenzyme MB activity in serum
using immunological inhibition of creatine kinase M subunit
activity. Activity kinetics and diagnostic significance in myocar-
dial infarcton. Clin.Chim.Acta. 73,(1976),445
Lot Number
Expiration date
(01/2005)
FTAN-CMSL-2

CK-MB
For in vitro diagnostic use only Ref : CKMB - 0030 20 x 3 mL
PRINCIPLE Total CK : At 30° C At 37° C

This procedure involves measurement of CK activity in the pre- Male : > 131 > 196
sence of an antibody to CK-M monomer. This antibody com- Female : > 111 > 171
pletely inhibits the activity of CK-MM and half of the activity of CK-MB : > 15 > 25
CK-MB while not affecting the B subunit activity of CK-MB and
CK-MB
CK-BB. Then we use the CK method to quantitatively determine CK-MB ratio ( x 100) : 6-25 %
CK-B activity. The CK-MB activity is obtained by multiplying Total CK
the CK-B activity by two.
REAGENTS COMPOSITION maintain its own reference values. The given data here are only
an indication.
Reagent 1 : R1
Anti-human polyclonal CK-M antibody (Goat)
sufficient to inhibit up to 2000 U/L of CK-MM PROCEDURE
at 37°C. This reagent can be used manually (see method below) and
Surfactant. on most analysers.
Reagent 2 : R2 The applications are available on request.
Tris buffer, pH 7,10 30 mmol/L Wavelength : 340 nm
Magnesium acetate 10 mmol/L Temperature : 37°C, 30°C
N-Acetyl-L-Cysteine 20 mmol/L Cuvette : 1 cm light path
ADP 2 mmol/L Read against distilled water.
AMP 5 mmol/L
NADP 2 mmol/L Working reagent : 1 mL
D-Glucose 20 mmol/L
Diadenosine pentaphosphate 10 µmol/L Sample : 50 µL
EDTA 2 mmol/L
Hexokinase ≥ 3500 U/L Mix and after a 5 minute incubation, measure the change of
G-6-PDH ≥ 2000 U/L optical density per minute (∆OD/min.) during 3 minutes
Creatine phosphate 30 mmol/L
a) Total CK activity :
These reagents contain less than 0.1 % sodium azide. Determine total CK activity in serum using the CK-NAC
reagent.
b) CK-B activity :
CK-B (U/L) = ∆OD/min x 3 376
c) CK-MB activity :
PREPARATION AND STABILITY CK-MB (U/L) = CK-B (U/L) x 2
OF WORKING REAGENT d) Percentage of CK-MB activity in sample :
% CK-MB = CK-MB x 100
Stability : 24 hours at 20-25° C Total-CK
3 days at 2-8° C QUALITY CONTROL
SAMPLES To ensure adequate quality, control sera are recommended.
LINEARITY
REFERENCE VALUES Inhibition : up to 2000 U/L of CK-MM at 37° C.
If the assay of the total CK exceeds 1200 U/L at 37°C, dilute
30° C 37° C
the sample appropriately with physiological saline before
0-14 U/L 0-24 U/L
assay of CK-MB.
The suspicion of myocardial damage is based on the 3 follo-
Multiply the result by the dilution factor to obtain the correct
wing factors :
value of the isoenzyme.
.../...
(01/2005)
FTAN-CKMB-3

CK-MB
LIMITATION OF THE PROCEDURE

1. The method will also measure any CK-BB isoenzyme pre-
sent in serum. The activity of this isoenzyme is usually
negligible, however, if a significant amount of CK-BB acti-
vity is present the CK-MB activity will be overestimated.
2. A macro form of BB (immunoglobulin complexed) has been
observed which will be measured as B in this assay. If the
measured CK-B activity exceeds 20 % of the total CK acti-
vity, the presence of macro BB should be suspected.
BIBLIOGRAPHY
1.Morison I. M., Clayson J. and Fine J. S. Clin. Chem., 34,
(1988), 535 .
2.Chan D. W; , Taylor E., Frye R. and Blitzer R.L., Clin. Chem.,
31, (1985) 465.
3.Morin L., Clin. Chem., 23/4, (1977), 646.
Lot Number
Expiration date
(01/2005)
FTAN-CKMB-3

COPPER
For in vitro diagnostic use only Ref : CUIV - 0050 5 x 10 mL

At pH 4,70 cupric copper is released from the ceruloplasmin Male : 70 - 140 µg/dL
complex. Ascorbic acid acts to reduce the cupric copper to 0.70 - 1.40 mg/L
cuprous state which reacts whi 3.5-DiBr-PAESA to produce a 11.0 - 22.0 µmol/L
coloured complex. Female : 80 - 155 µg/dL
552 0.80 - 1.55 mg/L
12.6 - 24.4 µmol/L
Reagent 1 : R1
Buffer, pH 5.00 an indication.
Additives
PROCEDURE
Reagent 2 : R2
Complexant 3.5-DiBr-PAESA
on most analysers.
Reagent 3 : R3 The applications are available on request.
Ascorbic acid (spoon supplied) Wavelength : 580 nm (570-590)
Standard : Std Temperature : 37°C
Cuvette : 1 cm light path.
Copper 100 µg/dL
15.73 µmol/L Read against reagent blank.
WR 2 1 mL 1 mL 1 mL
Standard - 50 µL -
PREPARATION AND STABILITY Sample - - 50 µL
OF WORKING REAGENTS
WR 1 : dissolve 3 levels measuring spoonful of the reagent 3
in the reagent 1.
WR 1 1 mL 1 mL 1 mL
Stability : 7 days at 2-8°C Distilled water 50 µL - -
Standard - 50 µL -
WR 2 : mix 10 volumes of WR 1 with 0.5 volume of the Sample - - 50 µL
reagent 2. Mix and read the optical density (OD1)
Stability : 3 to 4 hours at 20-25°C
Reagent 2 50 µL 50 µL 50 µL
Mix and read the optical density (OD2) after a 5 minute incubation.
The final colours are stable for at least 1 hour.
WR 1 : dissolve 3 levels measuring spoonful of the reagent 3
in the reagent 1. CALCULATION
• One-reagent procedure :
OD Sample µg/dL n= 100
xn
Reagent 2 : ready for use OD Standard µmol/L n = 15.73
• Two-reagent procedure :
SAMPLES OD2 - OD1 Sample µg/dL n= 100
xn
Serum and heparin plasma. OD2 - OD1 Standard µmol/L n = 15.73
Discard hemolyzed samples. n = standard concentration
.../...
(01/2005)
FTAN-CUIV-2

COPPER
QUALITY CONTROL
mended.
LINEARITY
Up to 500 µg/dL (5 mg/L) (78.65 µmol/L).
BIBLIOGRAPHY
Abe A., Yamashita S. and Al., Sensitive, Direct Colorimetric
Assay for Copper in Serum, Clin. Chem., 35, (1989),
Lot Number
Expiration date
(01/2005)
FTAN-CUIV-2

CREATININE J A F F E
Ref : CRCO - 0600 2 x 125 mL

For in vitro diagnostic use only Ref : CRCO - 0700 4 x 250 mL
CLINICAL SIGNIFICANCE (1,2)

Creatinine is the waste spontaneous product of creatine meta- )SAMPLES (5)
bolism. It is an excellent marker of the renal function. The - Specimen
serum creatinine rate tends to remain constant. A high serum Serum.
creatinine rate (associated to a high urea rate) corresponds to Fluoride or heparinized plasma.
a decrease in renal glomerular filtration (FGR). The serum 24h-Urine to be diluted 1/20 with distilled water before analy-
creatinine test is more reliable than the urea test. Indeed, the sis (when there is no predilution by the analyser).
urea serum rate is affected by factors such as diet, dehydrata-
tion degree and protein metabolism (the serum creatinine rate - Storage
is not influenced by these factors). The test of creatinine clea- Serum are stable for 24 hours at 2-8°C.
rance can also be used to measure the FGR. In the case of Urines are stable for 4 days at 2-8°C.
renal transplantation, any increase in serum creatinine, as lit- For longer storage, samples must be frozen after collection.
tle as it may be, can reflect the rejection of the transplant. An
increase of creatinine serum and urine can be the sign of mus- REFERENCE VALUES (5)
cular necrosis.
Men Women
Serum: 0.8 - 1.3 0.6 - 1.2 mg/dL
)METHOD 8 - 13 6 - 12 mg/L
Colorimetric, Jaffe 71 - 115 53 - 106 µmol/L
Kinetic
Urine: 0.8 - 2.0 0.6 - 1.8 g/24h
PRINCIPLE (3-4) 7.1 -17.7 5.3 - 15.9 mmol/24h
The rate of formation of a coloured complex between creatinine Note : It is recommended for each laboratory to establish and
and alkaline picrate is measured. The effect of interfering maintain its own reference values. The given data here are only
substances are reduced using the kinetic procedure. an indication.
REAGENTS COMPOSITION PROCEDURE

These reagents can be used manually (see method below)
Reagent 1 : R1 and on most analysers. The applications are available on
Picric acid 8.73 mmol/L request.
Reagent 2 : R2 Wavelength : 492 nm (480-520)
Sodium hydroxide 312.5 mmol/L Temperature : 37°C
Disodium phosphate 12.5 mmol/L Cuvette : 1 cm light path

Standard : Std
Creatinine 2 mg/dL Working reagent : 1 mL
20 mg/L
176.8 µmol/L Standard or Sample : 100 µL
Mix and read the optical density (OD1) 10 seconds after the
)PRECAUTIONS sample or standard addition. Exactly 2 minutes after the first
- The reagent R2 contains sodium hydroxide. It is irritant (Xi).
reading, take second reading (OD2).
R36/38: Irritating to eyes and skin.
S26 : In case of contact with eyes, rinse immediately with
plenty of water and seek medical advice. CALCULATION
S37/39: Wear suitable gloves and eye/face protection. ∆OD Sample mg/dL n= 2
xn
∆OD Standard mg/L n= 20
minations.
µmol/L n = 176.8
Take dilution factor into account for calculation of concentration
in urine.
PREPARATION AND STABILITY CALIBRATION

OF WORKING REAGENT Creatinine standard is traceable to the Standard Reference
Material, SRM 914.
Mix 1 volume of the reagent 1 with 1 volume of the reagent 2.
.../...
Stability : 1 month at 20-25°C
(04/2004)
FTAN-CRCO-6

CREATININE JAFFE
QUALITY CONTROL - Interferences (6)

To ensure adequate quality, control sera such as ELITROL I According to SFBC recommendations, some studies have been
(normal control) and ELITROL II (abnormal control) are recom- performed to determine the level of interference from different
mended. components:
PERFORMANCE DATA 550 mg/dL (5.5 g/L, 29.7 mmol/L).
The following data were obtained using the COBAS MIRA Bilirubin : Negative bias from 3 mg/dL (30 mg/L,
analyser (37°C) 51 µmol/L) for level serum at 2.15 mg/dL
Negative bias from 25 mg/dL
- Analytical range (250 mg/L, 428 µmol/L) for level serum at
The reagent is linear from 0.3 to 15 mg/dL ( 3 to 150 mg/L, 30 7.8 mg/dL.
to 1300 µmol/L).
Haemoglobin : Negative bias from 200 mg/dL (2 g/L)
Determined according to SFBC protocol, the detection limit is Turbidity : No significant interference up to 500 mg/dL
equal to 0.17 mg/dL (1.7 mg/L; 15 µmol/L). Triglycerides equivalent (5 g/L, 5.75 mmol/L).
Ascorbic acid : None at physiological concentrations

- Sensitivity Positive bias from 20 mg/dL (200 mg/L, 1.13
The average variation of the analytical signal is 25.6 × 10-3 ∆A
mmol/L)
per mg/dL of creatinine (2.56 × 10-3 ∆A per mg/L, 0.29 ∆A per
)BIBLIOGRAPHY
- Precision 1.Allston, C.A., Non protein nitrogenous compounds and renal
function. Clinical Chemistry: Concepts and Application,
Within-run Anderson, S.C., Cockayne, S. (W.B. Saunders eds. Philadel-
Low level : phia USA), (1993), 369.
n = 20 m = 0.68 mg/dL CV = 5.7 % 2.Newman, D.J., Price C.P., Non protein nitrogen metabolite.
Medium level : Tietz Fundamentals of Clinical Chemistry, 5th Ed., Burtis,
n = 20 m = 1.84 mg/dL CV = 1.9 % C.A. & Ashwood, E.R. (W.B. Saunders eds. Philadelphia USA),
High level : (2001), 414.
n = 20 m = 7.04 mg/dL CV = 1.1% 3.Butler, A.R., The Jaffe reaction. Identification of the coloured
species. Clin. Chim. Acta., (1975), 59, 227.
4.Vasiliades, J., Reaction of alkaline picrate with creatinine. 1.
Between-run Kinetics and mechanism of formation of the mono-creatinine
Low level : picric acid complex. Clin. Chem., (1976), 22, 1664.
n = 10 m = 1.6 mg/dL CV = 2.5 % 5.Tietz, N.W. Clinical guide to laboratory tests, 3th Ed, (W.B.
Medium level :
n = 10 m = 2.9 mg/dL CV = 2.0 % 6.Vassault A., et al., Protocole de validation de techniques,
(Document B, stade 3). Ann. Biol. Clin., (1986), 44, 686.
High level :
n = 10 m = 6.3 mg/dL CV = 1.9 %
)SYMBOLS USED ON LABELS:
- Correlation Lot Number
method and another commercial reagent on 38 human serum Consult instruction for use
samples. The sample concentrations were between 0.19 and
6.35 mg/dL.
The parameters of linear regression are as follows : Manufacturer’s address
Linear regression : y = 0.935 x + 0.008 mg/dL
Expiration date
(04/2004)
FTAN-CRCO-6

CREATININE PAP SL
For in vitro diagnostic use only Ref.: CRSL - 0630 2 x 133 mL
CLINICAL SIGNIFICANCE (1-2) SAMPLES (4)

Creatinine is the waste spontaneous product of creatine metabo- - Specimen
lism. It is an excellent marker of the renal function. The serum Non hemolyzed serum.
creatinine rate tends to remain constant. A high serum creatinine 24h-Urine to be diluted 1/20 with distilled water before analysis
rate (associated to a high urea rate) corresponds to a decrease in (when there is no predilution by the analyser).
renal glomerular filtration (FGR). The serum creatinine test is more - Storage
reliable than the urea test. Indeed, the urea serum rate is affected Serum are stable for 24 hours at 2-8°C.
by factors such as diet, dehydratation degree and protein metabo- Urines are stable for 4 days at 2-8°C.
lism (the serum creatinine rate is not influenced by these factors). For longer storage, samples must be frozen after collection.
The test of creatinine clearance can also be used to measure the
FGR. In the case of renal transplantation, any increase in serum REFERENCE VALUE (4)
creatinine, as little as it may be, can reflect the rejection of the Men Women
transplant. An increase of creatinine serum and urine can be the Serum: 0.8 - 1.3 0.6 - 1.2 mg/dL
sign of muscular necrosis. 8 - 13 6 - 12 mg/L
71 - 115 53 - 106 µmol/L
METHOD (3)
Enzymatic - Colorimetric Urine: 0.8 - 2.0 0.6 - 1.8 g/24h
Kinetic 7.1 - 17.7 5.3 - 15.9 mmol/24h
PRINCIPLE (3) Note : It is recommended for each laboratory to establish and main-
Enzymatic colorimetric determination of creatinine: tain its own reference values. The data given here are only an indi-
cation.
Creatininase
Creatinine + H2O Creatine )PROCEDURE
This reagent can be used on most analysers. The applications are
Creatinase available on request.
Creatine + H2O Sarcosine + Urea
Wavelength: 550 nm
Sarcosine oxidase Temperature: 37°C
Sarcosine + O2 Glycine + HCHO + H2O2 Read against reagent blank
Peroxidase BLANK STANDARD SAMPLE

H2O2 + EHSPT + 4-AAP Quinoneimine
Reagent R1 220 µL 220 µL 220 µL
4-AAP : Amino-4-Antipyrine Distilled water 5 µL - -
EHSPT : N-Ethyl-N-(2(-Hydroxy-3-Sulfopropyl)-m-Toluidine
Standard - 5 µL -
REAGENT COMPOSITION Sample - - 5 µL
Reagent R1
EHSPT 0.4 mmol/L
Mix, and wait for 200 seconds at 37°C, then add:
Creatinase ≥ 10 000 U/L
Sarcosine Oxidase ≥ 3 500 U/L Reagent R2 70 µL 70 µL 70 µL
Ascorbate Oxidase ≥ 1 000 U/L
Mix and read the variation of absorbance (∆A) between 100 and
Reagent R2 225 seconds.
Amino-4-Antipyrine 2.95 mmol/L
Creatininase ≥ 150 000 U/L
CALCULATION
Peroxidase ≥ 4 000 U/L
∆Asample
PRECAUTIONS x n n = standard concentration.
- Use clean or single use laboratory equipment only to avoid ∆Astandard
contaminations.
- The reagent R2 contains less than 0.1 % sodium azide. Sodium Take dilution factor into account for calculation of creatinine
azide can react with copper and lead plumbing to form explosive
metal azides. CALIBRATION
Regulations currently in use regarding dangerous waste elimina- On Cobas Mira, calibration must be performed at least every week,
tion must be respected. If discharge in the canalisations, rinse after each change of batch and according to quality control results
with plenty of water.
QUALITY CONTROL
STABILITY OF REAGENTS To ensure adequate quality, control sera such as ELITROL I (nor-
When stored at 2-8° C and protected from light, the reagents are mal control) and ELITROL II (abnormal control) are recommended.
.../...
WORKING REAGENT
The reagents R1 and R2 are ready for use. (01/2005)
FTAN-CRSL-4

CREATININE PAP SL
PERFORMANCES DATA Turbidity: No significant interference up to 600 mg/dL

The following data were obtained using the COBAS MIRA ana- Triglycerides eq. (6 g/L; 6.9 µmol/L).
lyser (37°C). Ascorbic acid: No significant interference up to 15 mg/dL (150
- Analytical range mg/L; 0.83 mmol/L).
The reagents are linear with serum from 0.3 to 30 mg/dL (3-300 Haemoglobin: Positive bias from 75 mg/dL (0.75 g/L) on normal
mg/L, 26-2650 µmol/L), and from 10 to 300 mg/dL (100-3000 serum. No significant interference up to 500 mg/dL (5 g/L) on
mg/L, 0.885-26.5 mmol/L) for urine. pathological serum.
Calcium dobesilate: Negative bias on normal serum from 2 mg/dL
(20 mg/L) and from 5 mg/dL (50 mg/L) on pathological serum.
Determined according to SFBC protocol, the detection limit for
Methyldopa: Negative bias on normal serum from 0.5 mg/dL (5
serum program is equal to 0.25 mg/dL (2.5 mg/L), (22 µmol/L).
mg/L). No significant interference up to 1 mg/dL (10 mg/L) on
For urine program, the detection limit is equal to 3.8 mg/dL (38
pathological serum.
mg/L) (335 µmol/L).
- Sensitivity Urine:
The average variation of the analytical signal is 4.25 ×10-3 ∆A for Conjugated bilirubin: No significant interference up to 25 mg/dL
1 mg/dL of creatinine (0.425×10-3 ∆A per mg/L, 48 ×10-3 ∆A per (250 mg/L; 427 µmol/L).
mmol/L) for a light path of 1 cm. Glucose: No significant interference up to 1000 mg/dL (10 g/L, 54
mmol/L).
- Precision
Ascorbic acid: No significant interference up to 0.2 g/dL (2 g/L; 11
Serum:
mmol/L).
Within-run Between-run Haemoglobin: No significant interference up to 500 mg/dL (5 g/L)
Mean Mean Calcium dobesilate: Negative bias from 30 mg/dL (300 mg/L)
n CV% n CV% Methyldopa: Negative bias on pathological urines from 5 mg/dL
(mg/L) (mg/L)
SH1 20 6.3 3.2 87 6.3 5.9 (50 mg/L), and from 40 mg/dL (400 mg/L) on normal urines.
SH2 20 16.4 1.9 88 16.2 3.2
SH3 20 65.3 1.0 88 64.9 3.3 BIBLIOGRAPHY
1.Allston, C.A., Non protein nitrogenous compounds and renal func-
Urine: tion. Clinical Chemistry: Concepts and Application, Anderson,
Within-run Between-run S.C., Cockayne, S. (W.B. Saunders eds. Philadelphia USA), (1993),
369.
Mean Mean
n CV% n CV% 2.Newman, D.J., Price C.P., Non protein nitrogen metabolite. Tietz
(mg/L) (mg/L)
Fundamentals of Clinical Chemistry, 5th Ed., Burtis, C.A. &
U1 20 110 4.0 80 108.2 4.7 Ashwood, E.R. (W.B. Saunders eds. Philadelphia USA), (2001),
U2 20 880 0.9 80 862 5.3 414.
U3 20 2239 1.1 86 2249 4.9 3.Fossati, P., Prencipe, L., Berti, G., Enzymatic Creatinine assay: a
colorimetric method based on hydrogen peroxide measurement.
- Correlation Clin. Chem., (1983), 29, 1494.
Serum:
A comparative study has been performed between Elitech method 4.Tietz, N.W., Clinical guide to laboratory tests, 3rd Ed, (W.B.
and an other commercial test on 82 human serum samples. The Saunders eds. Philadelphia USA), (1995), 186.
sample concentrations were between 0.3 and 36 mg/dL. The para- 5.Vassault A., et al., Protocole de validation de techniques,
meters of linear regression are as follows: (Document B, stade 3). Ann. Biol. Clin., (1986), 44, 686.
Correlation coefficient: (r) = 0.9995
6.Vassault, A., et al., Analyses de biologie médicale: spécifications
Linear regression: y = 0.930 x + 0.0792 mg/dL
et normes d'acceptabilité à l'usage de la validation des techniques.
Urine : Ann. Biol. Clin. (1999), 57, 685
and an other commercial test on 53 human urine samples. The
sample concentrations were between 1.5 and 345 mg/dL. The
parameters of linear regression are as follows:
Correlation coefficient: (r) = 0.998 Lot Number
Linear regression: y = 1.004 x + 0.0993 mg/dL.
- Interferences (5-6) Consult instruction for use
According to SFBC recommendations, some studies have been per-
formed to determine the level of interference different components. In vitro diagnostic medical device
The results are as follows:
Serum: Manufacturer’s address
Unconjugated bilirubin: No significant interference up to 36
mg/dL (360 mg/L; 616 µmol/L). Temperature limitation
Conjugated bilirubin: No significant interference up to 25 mg/dL
(250 mg/L; 427 µmol/L). Expiration date
Glucose: No significant interference up to 500 mg/dL (5 g/L;
27 mmol/L).
(01/2005)
FTAN-CRSL-4

GAMMA GT SL
Ref : GASL - 0400 2 x 62.5 mL

Ref : GASL - 0420 4 x 62.5 mL
For in vitro diagnostic use only Ref : GASL - 0500 5 x 125 mL

Optimized kinetic determination of g-glutamyl transferase ( γ-GT) :
an indication.
γ-GT
GLUPA-C + glycylglycine L- g-Glutamyl- glycylglycine + PROCEDURE
5-Amino-2-nitrobenzoic acid
on most analysers.
GLUPA-C : L- γ-Glutamyl-3-carboxy-p-nitroanilide The applications are available on request.
The increase of the absorption at 405 nm, due to the formation
of the 5-Amino-2-nitrobenzoic acid, is proportional to the γ-GT Wavelength : 405 nm
activity. Temperature : 30°C, 37°C
REAGENT COMPOSITION
Reagent 1 : R1 • One-reagent procedure
Glycylglycine 138 mmol/L Working reagent : 1 mL
Sample : 100 µL
Reagent 2 : R2
Glupa-C 23 mmol/L
PRECAUTIONS optical density per minute (∆OD/min.) during 3 minutes.
These reagents contain less than 0.1 % sodium azide. • Two-reagent procedure

(pipette, plastic vial for analysers,...). Reagent 1 : 1 mL
Sample : 100 µL
When stored at 2-8 °c and protected from light, the reagents
are stable until the expiry date stated on the label. Mix and wait 1 minute
PREPARATION AND STABILITY Reagent 2 : 250 µL

• One-reagent procedure Mix and after a 1 minute incubation, measure the change of
Mix 4 volumes of reagent 1 with 1 volume of reagent 2. optical density per minute (∆OD/min.) during 3 minutes.
Stability : 5 days at 20-25 °C

CALCULATION
3 weeks at 2-8 °C
SAMPLE Activity (U/L) = ∆OD/min. x 1421
REFERENCE VALUES QUALITY CONTROL

30°C 37°C (normal control) and ELITROL II (abnormal control) are recom-
Female : 4 - 25 U/L 5 - 32 U/L mended.
Male : 7 - 34 U/L 10 - 45 U/L
.../...
(01/2005)
FTAN-GASL-3

GAMMA GT SL
LINEARITY
result by 10.
BIBLIOGRAPHY
1.Szasz, G. Clin., Chem., 22, (1976), 2051.
2.SFBC, Commission d’enzymologie. Détermination d’une
méthode recommandée pour la détermination dans le sérum
humain de la concentration catalytique de la gamma-glutamyl
transférase à 30 °C. I.S.B, 12/5 (1986) 373
Lot Number
Expiration date
(01/2005)
FTAN-GASL-3

GAMMA G T
Ref : GAGT - 0030 20 x 3 mL

For in vitro diagnostic use only Ref : GAGT - 0200 12 x 20 mL
PRINCIPLE PROCEDURE
Optimized kinetic determination of g-glutamyl transferase (γ-GT) : This reagent can be used manually (see method below) and
γ-GT on most analysers.
GPNA + glycylglycine L-gGlutamyl- glycylglycine + p-Nitroanilide The applications are available on request.
Wavelength : 405 nm
GNPA : L-γ Glutamyl-p-nitroalinide.
The increase of the absorption at 405 nm, due to the formation of Cuvette : 1 cm light path
the p-nitroanilide, is proportional to the γ-GT activity.
REAGENTS COMPOSITION Working reagent : 1 mL

Reagent 1 : R1
Sample : 100 µL
Surfactant 0.2 % Mix and after a 1 minute incubation, measure the change of
Reagent 2 : R2
Glycylglycine 94 mmol/L CALCULATION
L-g-glutamyl-p-nitroanilide 3.2 mmol/L
Activity (U/L) = ∆OD/min. x 1 111
PRECAUTION QUALITY CONTROL

The reagent 1 contains less than 0.1 % sodium azide. (normal control) and ELITROL II (abnormal control) are recom-
mended.
When stored at 2-8° C and protected from light, the reagents LINEARITY
result by 10.
OF WORKING REAGENT
BIBLIOGRAPHY
Mix strongly and wait for 15 minutes before using.
Szasz G., Clin. Chem., 22, (1976), 2 051.
Note : The stirring is very important to avoid a cloudy reagent
and to prevent erroneous results.
Stability : 5 days at 20-25°C Lot Number
3 weeks at 2-8°C
or until the reconstitued reagent reaches an Consult instruction for use
optical density of 0.800 at 405 nm against distilled
water. In vitro diagnostic medical device
SAMPLE Manufacturer’s address
Serum free of hemolysis. Temperature limitation
REFERENCE VALUES Expiration date
30°C 37°C
Female : 4 - 25 U/L 5 - 32 U/L
Male : 7 - 34 U/L 10 - 45 U/L

an indication.
(01/2005)
FTAN-GAGT-2

GLUCOSE HK SL

Ref : GHSL - 0600 5 x 125 mL

Enzymatic determination of glucose according to the following reactions : Serum, plasma : 74 - 106 mg/dL
HK 0.74 - 1.06 g/L
Glucose + ATP G-6-P + ADP 4.50 - 5.90 mmol/L
G-6-PDH
G-6-P + NAD Gluconate-6-phosphate + NADH + H+ Cerebral Spinal fluid : 40 - 70 mg/dL
0.40 - 0.70 g/L
2.20 - 3.90 mmol/L
HK = Hexokinase
G-6-P = Glucose-6-phosphate Note : It is recommended for each laboratory to establish and
G-6-PDH = Glucose-6-phosphate dehydrogenase maintain its own reference values. The given data here are only
an indication.
PROCEDURE
Reagent 1 : R1 This reagent can be used manually (see method below) and
Pipes buffer, pH 7.60 80 mmol/L on most analysers.
NAD 3 mmol/L The applications are available on request.
ATP 1.7 mmol/L
Reagent 2 : R2 Temperature : 37° C
Magnesium salt 4 mmol/L Cuvette : 1 cm light path
Hexokinase ≥ 1 700 U/L Read against reagent blank.
G-6-PDH ≥ 1 700 U/L
Concentrations are given in working reagent.
PRECAUTIONS
Working Reagent 1 mL 1 mL 1 mL
Avoid contamination by using clean laboratory material Standard - 10 µL -
(pipettes, plastic vials for analysers, ...). Sample - - 10 µL
• Two-reagent-procedure
are stable until the expiry date stated on the label. BLANK STANDARD SAMPLE
PREPARATION AND STABILITY R1 1 mL 1 mL 1 mL

OF WORKING REAGENTS Distilled water 10 µL - -
Standard - 10 µL -
• One-reagent procedure :
Sample - - 10 µL
Mix 4 volumes of the reagent 1 with 1 volume of the reagent 2.
Stability : 2 weeks at 20-25° C Mix, wait 1 minute and add
2 months at 2-8° C
R2 250 µL 250 µL 250 µL
• Two-reagent procedure :
The reagents are ready for use. Mix and read the optical density (OD) after a 5 minute incubation.
CALCULATION
SAMPLES
Serum free of hemolysis. xn g/L n= 1
Heparin fluoride plasma. OD Standard mmol/L n= 5.56
Cerebral spinal fluid (CSF). n = standard concentration
.../...
(01/2005)
FTAN-GHSL-3

GLUCOSE HK SL
QUALITY CONTROL
mended.
LINEARITY
Up to 600 mg/dL (6 g/L) (33.3 mmol/L).
Note : Samples up to 9 g/L can be determined on analyzers

using cuvette of less than 1 cm light path or using a 5 µL sam-
ple with manual procedure.
BIBLIOGRAPHY
1.Peterson, J.L., Young, D.S., Anal Biochem., 23, (1968), 301.
2.Bondar, R.J.L., Mead, D.C., Clin. Chem., 20, (1974), 586.
3.Young, D.S., Pestaner, L.C., Gibberman, V., Clin. Chem., 5,
(1975), 1D.
4.Tietz.Fundamentals of Clinical Chemistry.Chap.23, 447
(2001)
Lot Number
Expiration date
(01/2005)
FTAN-GHSL-3

GLUCOSE PAP SL
Ref.: GPSL - 0490 1 x 100 mL

Ref.: GPSL - 0500 6 x 100 mL
For in vitro diagnostic use only Ref.: GPSL - 0700 4 x 250 mL
)CLINICAL SIGNIFICANCE (1-3) STABILITY OF REAGENTS

Glucose is the main source of energy for the human body. When stored at 2-8° C and protected from light, the reagent is
Glucose is converted either into glycogen to be stocked in the stable until the expiry date stated on the label.
liver or into triglycerides to be stocked in fatty tissues. Glucose
concentration in blood is regulated by several hormones, PREPARATION AND STABILITY
including two antagonists: insulin and glucagon. OF WORKING REAGENT
Quantification of glucose in blood is used to diagnose metabo- The reagent is ready for use.
lic carbohydrates disorders such as diabetes, neonatal glycae-
mia, idiopathic hypoglycemia and pancreatic disease. )SAMPLES (2,3)
The main physiological troubles are linked to hyperglycaemia - Specimen
(type I Diabetes mellitus and type II Diabetes mellitus). Type I Serum free of hemolysis.
diabetes mellitus is insulin-dependent, and appears mainly Plasma collected on fluorure or heparin/iodoacetate or any
before 30 years old. Type II diabetes mellitus is non-insulin- inhibitors of glycolysis.
dependent, and usually appears after 40 years old, but can
occur earlier for obese people. Other diabetes have secondary - Storage
origin, and appear after endocrinal or hepatic diseases. Serum is stable 8 hours at 25°C and up to 3 days at 2-8°C.
Plasma preserve with sodium fluoride and iodoacetate is sta-
ble for 24 hours at room temperature.
METHOD
Enzymatic colorimetric.
Trinder. End point.

PRINCIPLE (4,5) 0.74 - 1.06 g/L
4.1 - 5.9 mmol/L
Enzymatic determination of glucose according to the following
reactions :
Glucose oxidase
Glucose + O2 Gluconic acid + H2O2 an indication.
Peroxidase
2H2O2 + Phenol + 4-Aminoantipyrine Quinoneimine + 4H20 PROCEDURE
REAGENTS COMPOSITION Temperature : 37° C
Reagent : R
Phosphate buffer, pH 7.4 13.8 mmol/L BLANK STANDARD SAMPLE
Phenol 10 mmol/L Working Reagent 1 mL 1 mL 1 mL
4-Aminoantipyrine 0.3 mmol/L Distilled water 10 µL - -
Glucose oxidase ≥ 10 000 U/L Standard - 10 µL -
Peroxidase ≥ 700 U/L Sample - - 10 µL
PRECAUTIONS Mix and measure the optical density (OD) after a 10 minute
incubation.
- The reagent contains less than 0.1 % sodium azide. Sodium The measure can be done during 30 minutes.
sive metal azides.
Regulations currently in use regarding dangerous waste elimi- CALCULATION
nation must be respected. If discharge in the canalisations, mg/dL n= 100
OD Sample
rinse with plenty of water. xn g/L n= 1
- Use clean or single use glass material only to avoid conta- OD Standard mmol/L n= 5.56
minations.
.../...
(02/2004)
FTAN-GPSL-4

GLUCOSE PAP SL
QUALITY CONTROL - Interferences (6)
To ensure adequate quality, control sera such as ELITROL I According to SFBC recommendations, studies have been per-
(normal control) and ELITROL II (abnormal control) are recom- formed to determine the level of interference from different
mended. compounds:
PERFORMANCE DATA
Bilirubin: Negative bias from 8 mg/dL (80 mg/L,
137 µmol/L).
analyser (37°C)
Haemoglobin: No significant interference up to 0.5 g/dL
- Analytical range (5 g/L).
The reagent is linear from 20 to 400 mg/dL (0.2 to 4 g/L; 1.11
Ascorbic acid: No significant interference at physiological
to 22.2 mmol/L).
concentrations (negative bias from 7 mg/dL;
70 mg/L; 0.39 mmol/L).
Determined according to SFBC protocol, the detection limit is Turbidity: No significant interference up to 600 mg/dL
equal to 2 mg/dL (0.02 g/L; 0.111 mmol/L). Triglyceride equivalent (6 g/L, 6.9 mmol/L).
Uric acid: No significant interference up to 20 mg/dL
)- Sensitivity (200 mg/L; 1190 µmol/L).
The average variation of the analytical signal is 2.7 × 10-3 ∆A
per mg/dL of glucose (0.27 ∆A per g/L, 48.5 × 10-3 ∆A per
)BIBLIOGRAPHY
1.Sacks, D.B., Carbohydrates. Tietz Fundamentals of Clinical
- Precision Chemistry, 5th Ed., Burtis, C.A. & Ashwood, E.R. (W.B.
Within-run reproducibility on serum Saunders eds. Philadelphia USA), (2001), 427.
Low level : 2.Dods, R.F., Diabetes Mellitus. Clinical Chemistry: Theory,
n = 20 m= 42 mg/dL CV = 1.5 % Analysis, Correlation, 4th Ed., Kaplan, L.A, Pesce, A.J.,
Medium level : Kazmierczak, S.C., (Mosby Inc. eds St Louis USA), (2003), 580.
n = 20 m = 109 mg/dL CV = 1.9 % 3.Tietz, N.W., Clinical guide to laboratory tests, 3th Ed., (W.B.
High level :
4.Trinder, P., Determination of glucose in blood using glucose
n = 20 m = 296 mg/dL CV = 1.3 % oxidase with an alternative oxygen acceptor. Ann. Clin.
Biochem., (1969), 6, 24.
Between-run reproducibility on serum 5.Burrin, JM., Price, C.P., Measurement of blood glucose. Ann.
Low level : Clin. Biochem., (1985), 22, 327.
n = 17 m = 41 mg/dL CV = 3.6 % 6.Vassault, A., et al., Protocole de validation de techniques,
Medium level : (Document B, stade 3). Ann. Biol. Clin., (1986), 44, 686.
n = 19 m = 107 mg/dL CV = 3.1 %
High level :
n = 18 m = 298 mg/dL CV = 1.6 % )SYMBOLS USED ON LABELS :
- Correlation
Lot Number
samples.The parameters of linear regression are as follows :
Linear regression : y = 1.001 x - 3.1 mg/dL Manufacturer’s address
Expiration date
(02/2004)
FTAN-GPSL-4

GLUCOSE PAP
Ref : GLUP - 0700 4 x 250 mL

Ref : GLUP - 0800 5 x 500 mL

Enzymatic colorimetric determination of glucose according to maintain its own reference values. The data given here are only
the following reactions : an indication.
Glucose oxidase PROCEDURE

Glucose + O2 Gluconic acid + H2O2
Peroxidase on most analysers.
2H2O2 + Phenol + 4-Aminoantipyrine Red quinone + 4H20 The applications are available on request.
REAGENTS COMPOSITION Temperature : 37° C
Reagent 1 : R1
Phosphate buffer, pH 7.40 100 mmol/L Read against reagent blank.
Phenol 10 mmol/L
Reagent 2 : R2
Glucose oxidase ≥ 10 000 U/L Working Reagent 1 mL 1 mL 1 mL
Peroxidase ≥ 600 U/L Distilled water 10 µL - -
4-Aminoantipyrine 270 µmol/L
Standard - 10 µL -
Standard : Std
Sample - - 10 µL
Glucose 100 mg/dL
1 g/L
5.56 mmol/L Mix and read the optical density (OD) after a 10 minute incubation.
PRECAUTIONS
CALCULATION
xn g/L n= 1
STABILITY OF REAGENTS OD Standard mmol/L n= 5.56
are stable until the expiry date stated on the label n = standard concentration
PREPARATION AND STABILITY QUALITY CONTROL

OF WORKING REAGENT To ensure adequate quality, control sera such as ELITROL I
Dissolve the reagent 2 in the suitable volume of reagent 1. mended.
Stability : 1 month at 20-25° C
LINEARITY
3 months at 2-8° C
SAMPLES
BIBLIOGRAPHY
Trinder P., Ann. Clin., Biochem, 6, (1969), 24.
Heparin, fluoride plasma free of hemolysis.
Cerebral spinal fluid. SYMBOLS USED ON LABELS:
REFERENCE VALUES Lot Number

0.70 - 1.05 g/L Consult instruction for use
3.89 - 5.84 mmol/L
Cerebral Spinal fluid : 50 - 70 mg/dL
0.50 - 0.70 g/L Manufacturer’s address
2.78 - 3.89 mmol/L
(01/2005)
Expiration date FTAN-GLUP-3

HBDH SL
For in vitro diagnostic use only Ref : HBSL - 0400 2 x 55 mL
PRINCIPLE Read against distilled water.

Kinetic determination of the a-hydroxybutyrate dehydrogenase • One-reagent procedure
(α-HBDH) based upon DGKC recommendations :
α-HBDH
α-Ketobutyrate + NADH + H+ α-Hydroxybutyrate + NAD+ Sample : 30 µL
Reagent 1 : R1
α-Ketobutyrate 6.2 mmol/L R1 : 1 mL
Reagent 2 : R2
Sample : 30 µL
NADH 240 µmol/L
Mix and wait 1 minute
Concentrations are given in working reagent.
PRECAUTIONS R2 : 100 µL
Avoid contamination by using clean disposable devices Mix and after a 1 minute incubation, measure the change of
(pipettes, plastic vials for analysers, ...). optical density per minute (∆OD/min.) during 3 minutes.
CALCULATION
STABILITY OF REAGENTS One reagent Two reagents
When stored at 2-8° C and protected from light, the reagents 340 nm : Activity (U/L) =∆OD/min. x 5 450 5 979
are stable until the expiry date stated on the label. 334 nm : Activity (U/L) = ∆OD/min. x 5 556 6 095
365 nm : Activity (U/L) = ∆OD/min. x 10 098 11 078
OF WORKING REAGENTS QUALITY CONTROL
• One-reagent procedure : To ensure adequate quality, control sera such as ELITROL I
mended.
Stability : 8 hours at 20-25° C
5 days at 2-8° C LINEARITY
• Two-reagent procedure : If ∆OD/min. exceeds 0.100 at 340 nm repeat test using serum
The reagents are ready for use. diluted 1/10 with sodium chloride solution (9 g/L).
Multiply result by 10.
SAMPLE
BIBLIOGRAPHY
Deutsche Gesellschaft für Klinische Chemie, Z. Klin. Chem. U.
REFERENCE VALUES
Klin. Biochem., 10, (1972), 182.
30° C 37° C
70 - 190 U/L 80 - 220 U/L SYMBOLS USED ON LABELS:
Note : It is recommended for each laboratory to establish and Lot Number

an indication. Consult instruction for use
PROCEDURE In vitro diagnostic medical device

This reagent can be used manually (see method below) and Manufacturer’s address
on most analysers.
The applications are available on request. Temperature limitation
Expiration date
Temperature : 30° C, 37° C (01/2005)
Cuvette : 1 cm light path FTAN-HBSL-3

HEMOGLOBIN
For in vitro diagnostic use only Ref : HEMO - 0400 1 x 50 mL
PRINCIPLE PROCEDURE
Hemoglobin (oxyhemoglobin, methemoglobin, carboxy-hemo- This method below is a manual method for spectrophotometer.
globin) is converted to cyanomethemoglobin according to the Wavelength : 540 nm (546)
following reactions : Temperature : 25° C, 30° C, 37° C
Potassium ferricyanide
Hemoglobin Methemoglobin Read against reagent blank.
Potassium cyanide
Methemoglobin Cyanomethemoglobin
REAGENTS COMPOSITION Sample : 20 µL

Drabkin reagent (50 times concentrated) :
Mix and read the optical density (OD) within 1 hour.
Potassium ferricyanide 30 mmol/L
Potassium cyanide 38 mmol/L
Monopotassium phosphate 50 mmol/L CALCULATION
Hemoglobin concentration : (g/dL) = OD x 36.8
PRECAUTIONS (g/L) = OD x 368
Warning : The reagent is TOXIC (mmol/L) = OD x 22.8
STABILITY OF REAGENTS LINEARITY

When stored at 2-25° C and protected from light, the reagent Up to 21 g/dL (210 g/L) (13 mmol/L).
is stable until the expiry date stated on the label.
Note : If the light path of the reading cuvette is not 1 cm and if
PREPARATION AND STABILITY the wavelength differs from 540 nm, prepare a calibration curve
OF WORKING REAGENT with cyanomethemoglobin standards.
Dilute Drabkin reagent 1/50 with distilled water.
Stability : 1 month at 20-25° C BIBLIOGRAPHY
1.Drabkin D.L., Etal J. Biol. Chem., 98, (1932), 719.
SAMPLE
2.Zijlstra N.C., Clin. Chim. Acta, 5, (1960), 719.
Fresh whole blood.
REFERENCE VALUES
Lot Number
New-born : 14 - 24 g/dL
140 - 240 g/L Consult instruction for use
9 - 15 mmol/L
Infants (up to 1 year) : 11.2 g/dL In vitro diagnostic medical device
112 g/L
6.95 mmol/L
Children (1-10 years) : 12.9 g/dL Temperature limitation
129 g/L
8 mmol/L Expiration date
Adult males : 14 - 18 g/dL

140 - 180 g/L
9 - 11 mmol/L
Adult females : 12 - 16 g/dL
120 - 160 g/L
7 - 10 mmol/L

an indication. (03/2005)
FTAN-HEMO-2

IRON CHROMAZUROL
For in vitro diagnostic use only Ref : FECA - 0600 2 x 125 mL
PRINCIPLE The applications are available on request.

Serum iron reacts with chromazurol B and cetyltrimethyl Wavelength : 637 nm
ammonium bromide to form a coloured complex. Temperature : 37° C
The intensity of the colour is proportional to the iron concen- Cuvette : 1 cm light path
tration.
Reagent : R
Chromazurol B 0.2 mmol/L
Cetyltrimethyl ammonium bromide 2 mmol/L Distilled water 50 µL - -
Guanidine hydrochloride 3 mol/L Standard - 50 µL -
Acetate buffer, pH 5.0 45 mmol/L Sample - - 50 µL
Standard : Std
Mix well, and read the optical density (OD) after a 15 minute
Iron III 100 µg/dL
incubation.
1 mg/L
17.9 µmol/L The final colour is stable for at least 1 hour.
HARMFUL ! Reagent contains guanidin. Risk if swallowed and µg/dL n= 100
irritating for eyes and skin. Wear suitable protective clothing OD Sample
xn mg/L n= 1
and eye/face protection. Avoid contact with eyes. In case of OD Standard µmol/L n= 17.9
contact with eyes , rinse immediately with plenty of water and
seek medical device. n = standard concentration
QUALITY CONTROL
When stored at 2-8° C and protected from light, the reagents (normal control) and ELITROL II (abnormal control) are recom-
are stable until the expiry date stated on the label. mended.
PREPARATION AND STABILITY LINEARITY

OF WORKING REAGENT Up to 500 µg/dL (5 mg/L) (89.5 µmol/L).
Note :
SAMPLES
• The glassware and deionized or distilled water must be
Serum. iron free.
Heparin plasma free of hemolysis. • Keep the vial tightly sealed.
REFERENCE VALUES BIBLIOGRAPHY

50 - 168 µg/dL
1.Garcia A., Clin. Chim. Acta, 94, (1979), 115.
0.5 - 1.68 mg/L
8.95 - 30 µmol/L 2.Callahan J.H. and Cook, K.O., Anal. Chem., 54, (1982), 59.
A number of well known factors influence the normal range of

total serum iron in clinically healthy individuals such as diet,
sex, age, physical activity, menstrual cycle, pregnancy, envi- Lot Number
ronmental conditions and diurnal fluctuations.
Note : It is recommended for each laboratory to establish and In vitro diagnostic medical device
an indication. Manufacturer’s address
PROCEDURE Temperature limitation

This reagent can be used manually (see method below) and Expiration date (01/2005)
on most analysers. FTAN-FECA-3

IRON FERROZINE ®
For in vitro diagnostic use only Ref : FEFR - 0600 2 x 125 mL
PRINCIPLE
A number of well known factors influence the normal range of
At pH 4.80 ferric iron is released from the transferrin complex. total serum iron in clinically healthy individuals such as diet,
Ascorbic acid acts to reduce the ferric iron to ferrous state sex, age, physical activity, menstrual cycle, pregnancy, envi-
which reacts with Ferrozine® to produce a colored complex. ronmental conditions and diurnal fluctuations.
Interference from cuprous ions is prevented by thiourea.
an indication.
Reagent 1 : R1
Acetate buffer, pH 4.80 100 mmol/L
PROCEDURE
Guanidine 4 mol/L This reagent can be used manually (see method below) and
Thiourea 52.5 mmol/L on most analysers.
Reagent 2 : R2
Ascorbic acid (spoon supplied) Wavelength : 560 nm (550-570)
Temperature : 37°C
Reagent 3 : R3
Ferrozine® 40 mmol/L
Standard : Std
Iron 100 µg/dL BLANK STANDARD SAMPLE
1 mg/L
17.9 µmol/L
PRECAUTIONS Standard - 200 µL -
Because the reagent 1 contains guanidine, it is harmful by Sample - - 200 µL
inhalation, if swallowed and irritating to eyes and skin. Wear
suitable protection ; if split, wash thoroughly with water. Mix and read the optical density (OD).
- OD1 OD2
When stored at 2-8° C and protected from light, the reagents Then add :
iare stable until the expiry date stated on the label.
R3 50 µL 50 µL 50 µL
Mix and read the optical density (OD) within one hour.
OF WORKING REAGENTS
Dissolve one level measuring spoonful (~ 150 mg) of reducing - OD3 OD4
agent (R2) in 50 mL of guanidine reagent 1.
Stability : 3 days at 20-25°C CALCULATION
2 weeks at 2-8°C OD4 - OD2 µg/dL n= 100
xn mg/L n= 1
The reagent 3 is ready for use. OD3 - OD1 µmol/L n= 17.9
SAMPLES n = standard concentration

Serum.
Discard hemolyzed samples. QUALITY CONTROL
REFERENCE VALUES (normal control) and ELITROL II (abnormal control) are recom-
mended.
50 - 168 µg/dL
0.5 - 1.68 mg/L
8.95 - 30 µmol/L
(01/2005)
FTAN-FEFR-3

IRON FERROZINE ®
LINEARITY
Up to 500 µg/dL (5 mg/L) (89.5 µmol/L).
BIBLIOGRAPHY
1.Williams and al., Clin. Chem., 23, (1977), 237.
2.Stoockey L., Anal. Chem., 42, (1970), 779.
3.Persijn and al., Clin. Chem. Acta, 35, (1971), 91.
Lot Number
Expiration date
(01/2005)
FTAN-FEFR-3

IRON T I B C
For in vitro diagnostic use only Ref : FECA - 0050 50 Tests
PRINCIPLE PROCEDURE
Total Iron-Binding Capacity (TIBC) is evaluated after satura- In a centrifugation tube, introduce :
tion of the transferrin by an iron solution and adsorption of
excess iron on magnesium hydroxide carbonate. After centri- Reagent 1 : 1 mL
fugation iron is measured in the supernatant.
Sample : 0.5 mL
Reagent 1 : R1
Mix and incubate for 5 minutes then add :
Iron saturating solution 500 µg/dL
5 mg/L
Reagent 2 : 1 level measuring spoonful
89.5 µmol/L (~ 100 mg) of magnesium
Reagent 2 : R2 hydroxide carbonate.
Magnesium hydroxide carbonate
One measuring spoon (~ 100 mg)
Incubate for 20 minutes, shaking several times during this
Additional reagent :
period. Centrifugate at 3000 r.p.m. during 10 minutes.
Kit for iron determination
(iron CAB or iron Ferrozine®) TIBC determination :
Iron content of the supernatant is measured colorimetrically
STABILITY OF REAGENTS with the iron CAB or iron Ferrozine® method. Take into
When stored at 2-8° C and protected from light, the reagents account the dilution 1 : 3 by the reagent 1 and multiply by 3
are stable until the expiry date stated on the label. each measurement value.
QUALITY CONTROL
OF WORKING REAGENT (normal control) and ELITROL II (abnormal control) are recom-
The reagents are ready for use. mended.
SAMPLES
BIBLIOGRAPHY
Ramsay W.N.M., Clin. Chim. Acta, 2, (1957), 221.
Heparin plasma.
REFERENCE VALUES SYMBOLS USED ON LABELS:

Male : 260 - 390 µg/dL
2.6 - 3.9 mg/L Lot Number
46.5 - 69.8 µmol/L
Female : 210 - 340 µg/dL
2.1 - 3.4 mg/L In vitro diagnostic medical device
37.6 - 60.9 µmol/L
an indication. Expiration date
(01/2005)
FTAN-TIBC-3

LACTATE
For in vitro diagnostic use only Ref : LACT - 0100 10 x 10 mL

Lactate is largely linked to the carbohydrate metabolism and Plasma : < 20 mg/dL
the control of blood pH value. Breakage of lactate to pyruvate < 0.200 g/L
and H2O2 is realized by lactate oxidase. The hydrogen < 2.19 mmol/L
peroxide produced reacts with 4-aminoantipyrine and ADPS in Cerebral Spinal Fluid : 10 - 26 mg/dL
the presence of peroxidase. The increase of color is proportio- 0.100 - 0.260 g/L
nal to the lactate concentration. 1.10 - 2.80 mmol/L
Lactate oxidase
Lactate + O2 Pyruvate + H2O2 Note : It is recommended for each laboratory to establish and
Peroxidase an indication.
2H2O2 + 4-Aminoantipyrine + ADPS Quinonimine + 4H2O
PROCEDURE
ADPS = N-Ethyl-N-sulfopropyl-m-anisidine. on most analysers.
REAGENTS COMPOSITION Temperature : 37°C
Reagent 1 : R1
ADPS 1 mmol/L BLANK STANDARD SAMPLE
Reagent 2 : R2
Working reagent 1 mL 1 mL 1 mL
Lactate oxidase ≥ 450 U/L
Peroxidase ≥ 2 000 U/L Distilled water 10 µL - -
4-Aminoantipyrine 0.40 mmol/L Standard - 10 µL -
Standard : Std Sample - - 10 µL
Lactic acid 40 mg/dL Mix and measure the optical density (OD) after a 5 minute incubation.
0.40 g/L
4.44 mmol/L CALCULATION
PRECAUTIONS xn g/L n= 0.40
The reagent 1 contains less than 0.1 % sodium azide. OD Standard mmol/L n= 4.44
QUALITY CONTROL
OF WORKING REAGENTS
Stability : 8 hours at 20-25°C
7 days at 2-8°C
.../...
SAMPLES
Heparin or EDTA plasma.
Serum.
Collect capillary or venous blood specimen from patients in a
relaxed position.
Cerebral spinal fluid (CSF).
(01/2005)
FTAN-LACT-2

LACTATE
LINEARITY
Up to 120 mg/dL (1.2 g/L) (13.2 mmol/L).
BIBLIOGRAPHY
1.Kuhnle, H.F. and al., J. Clin. Chem., 16, (1977), 171.
2.Kuhnle, H.F. and al., Clin. Biochem., 35, (1989), 1992.
Lot Number
Expiration date
(01/2005)
FTAN-LACT-2

LDH-P 4+1 SL
Ref.: LDSL - 0410 2 x 62.5 mL

Ref.: LDSL - 0430 4 x 62.5 mL
CLINICAL SIGNIFICANCE (1,2)

Two-reagent procedure
Lactate dehydrogenase can be found in nearly all cells of the The reagents are ready for use.
body with highest activities in myocardium, liver, kidney and
skeletal muscle. Consequently, elevations of LDH in the serum SAMPLES (1,2,4)
have been considered nonspecific for any disease or disorder. - Specimen
LDH increases in case of acute myocardial infarction, hepatic Serum free from hemolysis.
disorders (viral hepatitis, cirrhosis), muscular dystrophy, can-
cer, metastasis, anemia (hemolytic, megaloblastic), nephrotic - Storage
disorders and in numerous other diseases involving tissue Store sera at room temperature. Remove from clot and analyse
damage. promptly. Do not refrigerate or freeze the sera.
METHOD (3) REFERENCE VALUES (3,5)
Based on SFBC recommandations.

Serum (37°C): 235-470 U/L
Kinetic. UV.
Reference values for infants are higher than for adults.
Substrate: Pyruvate
(Values at 37°C are obtained from those at 30°C using a conversion fac-
PRINCIPLE (3) tor of 1.68).
Kinetic determination of lactate dehydrogenase (LDH) activity: Note : It is recommended for each laboratory to establish and
LDH an indication.
Pyruvate + NADH + H+ L-Lactate + NAD+
PROCEDURE
REAGENTS COMPOSITION These reagents can be used on most analysers. The applica-
Reagent 1: R1 tions are available on request.
Tris buffer, pH 7.20 (30°C) 100 mmol/L Wavelength : 340 nm
Sodium chloride 255 mmol/L Temperature : 37°C
Pyruvate 2 mmol/L Read against distilled water.
Reagent 2: R2 One-reagent procedure
NADH 1.3 mmol/L
Working reagent : 250 µL
PRECAUTIONS Sample : 3.5 µL
- The reagents contain less than 0.1% sodium azide. Sodium
Mix and after a 25 second incubation, measure the change of
sive metal azides.
Regulations currently in use regarding dangerous waste elimi- • Two-reagent procedure
nation must be respected. If discharge in the canalisations,
rinse with plenty of water. R1 : 200 µL
- Use clean or single use laboratory material only to avoid R2 : 50 µL
contaminations.
- High LDH values may induce falsely low results due to the Mix, wait 25 seconds and add:
depletion of the substrate (total consumption of NADH before
reading of the result). If an analyser is used, verify the pre- Sample : 3.5 µL
sence of a depletion factor on the application. Mix and after a 25 second incubation, measure the change of
When stored at 2-8°C and protected from light, the reagents
CALCULATION
At 340 nm, with the one-reagent procedure and the two-rea-
PREPARATION AND STABILITY OF WORKING REAGENT gent procedure for a 1 cm light path cuvette:
One-reagent procedure Activity (U/L) = ∆A/min. x 11496
Mix 4 volumes of the reagent R1 with 1 volume of the reagent R2.
1 week at 2-8°C .../...
(01/2005)
FTAN-LDSL4/1-3

LDH-P 4+1 SL
QUALITY CONTROL - Interferences (6,7)

formed to determine the level of interference from different
mended. compounds:
PERFORMANCE DATA Conjugated bilirubin: Negative bias from 8.5 mg/dL on normal
serum (85 mg/L, 150 µmol/L). Negative bias from 17.5 mg/dL on
pathological serum (175 mg/L, 300 µmol/L) .
analyser with the one and the two-reagent procedure
(37°C) Unconjugated bilirubin: Negative bias from 17,5 mg/dL on nor-
mal serum (175 mg/L, 300 µmol/L). Negative bias from 23 mg/dL
- Analytical range on pathological serum (230 mg/L, 400 µmol/L).
The reagent is linear from 50 to 1 500 U/L.
Turbidity: No significant interference up to 600 mg/dL
Triglycerides equivalent (6 g/L, 6.9 µmol/L).
equal to 20 U/L for the one-reagent procedure and to 26 U/L Note: Hemolysed sera should not be used since significant
hemolysis may increase LDH concentration because of high
for the two-reagent procedure.
levels of LDH in erythrocytes.
- Sensitivity
The average variation of the analytical signal is 0.087 m∆A/min. BIBLIOGRAPHY
per U/L of LDH for a light path of 1 cm.
1.Henderson, A.R., Moss, D.W., Enzymes. Tietz Fundamen-
- Precision tals of Clinical Chemistry, 5th Ed., Burtis, C.A. & Ashwood,
Within-run reproducibility: E.R. (W.B. Saunders eds. Philadelphia USA), (2001), 352.
2.Ward, M.K., Cockayne, S., Enzymology. Clinical Chemistry:
One-reagent procedure Two-reagent procedure Concepts and Application, Anderson, S.C., Cockayne, S. (W.B.
Mean Mean Saunders eds. Philadelphia USA), (1993), 238.
n CV (%) n CV (%)
(U/L) (U/L) 3.Vassault, A. et al., Recommandations pour la mesure de la
SH 1 20 175 3.6 20 168 3.1 concentration catalytique de la lactate déshydrogénase dans le
SH 2 20 351 2.4 20 338 2.1 serum humain à +30°C. Ann. Biol. Clin., (1982), 40, 87.
SH 3 19 961 2.3 20 926 1.2 4.Tietz, N.W., Clinical guide to laboratory tests, 3rd Ed., (W.B.
Between-run reproducibility: 5.Sanhai, W.R., Christensen, R.H., Cardiac and muscle
disease. Clinical Chemistry: Theory, Analysis, Correlation, 4th
One-reagent procedure Two-reagent procedure Ed., Kaplan, L.A, Pesce, A.J., Kazmierczak, S.C., (Mosby Inc.
Mean Mean eds St Louis USA), (2003), 566 and appendixe.
n CV (%) n CV (%)
(U/L) (U/L) 6.Vassault A., et al., Protocole de validation de techniques,
SH 1 88 173 5.8 86 167 6.5 (Document B, stade 3). Ann. Biol. Clin., (1986), 44, 686.
SH 2 88 345 4.8 88 333 3.9 7.Vassault A., et al., Analyses de biologie médicale: spécifica-
SH 3 85 947 2.8 88 929 3.1 tions et normes d’acceptabilité à l’usage de la validation des
techniques. Ann. Biol. Clin., (1999), 57, 685.

method and another commercial reagent on 79 human sera.
The sample concentrations ranged from 43 to 1452 U/L. Lot Number
The parameters of linear regressions are as follows :

One-reagent Two-reagent In vitro diagnostic medical device
procedure procedure
Correlation Manufacturer’s address
0.998 0.998
coefficient (r)
Linear regression y = 1.05 x -15.0 y = 1.05 x - 16.7
Expiration date
(01/2005)
FTAN-LDSL4/1-3

LDH - P
Ref : LDHP - 0030 20 x 3 mL

For in vitro diagnostic use only Ref : LDHP - 0200 12 x 20 mL
PRINCIPLE PROCEDURE
Kinetic determination of the lactate dehydrogenase based This reagent can be used manually (see method below) and
upon IFCC and SFBC recommendations : on most analysers.
LDH
Pyruvate + NADH + H+ L-Lactate + NAD+ Wavelength : 340 nm (334-365)
LDH = Lactate dehydrogenase Cuvette : 1 cm light path

Reagent 1 : R1 Working reagent : 1 mL
Tris buffer, pH 7.20 80 mmol/L Sample : 20 µL

Pyruvate 1.6 mmol/L Mix and after a 1 minute incubation, measure the change of
NADH 240 µmol/L
CALCULATION
PRECAUTIONS 340 nm : Activity (U/L) = ∆OD/min. x 8 095
When stored at 2-8° C and protected from light, the reagents QUALITY CONTROL
are stable until the expiry date stated on the label. To ensure adequate quality, control sera such as ELITROL I
OF WORKING REAGENT
Dissolve the reagent 2 in the suitable volume of reagent 1. LINEARITY
diluted 1/5 or 1/10 with sodium chloride solution (9 g/L).
4 weeks at 2-8°C
Multiply result by 5 or 10.
3 mL reagent stability : 4 days at 20-25°C
2 weeks at 2-8°C BIBLIOGRAPHY
Ann. Biol. Clin., 40, (1982), 123.
SAMPLE
REFERENCE VALUES
30°C 37°C Lot Number
140 - 280 U/L 200 - 400 U/L
maintain its own reference values. The data given here are only In vitro diagnostic medical device
an indication.
Expiration date
(01/2005)
FTAN-LDHP-3

MAGNESIUM
CALMAGITE
For in vitro diagnostic use only Ref : MAGN - 0600 2 x 125 mL
PRINCIPLE PROCEDURE
Magnesium forms a coloured complex with calmagite in alka- This reagent can be used manually (see method below) and
line solution. EGTA eliminates the calcium interference. on most analysers.
REAGENTS COMPOSITION Wavelength : 520 nm (500-550)
2-Methyl-2-Amino-1-Propanol 1 mol/L
EGTA 210 µmol/L Read against reagent blank.

Calmagite 0.30 mmol/L
Standard : Std
Magnesium 2 mg/dL
Standard - 10 µL -
20 mg/L
824 µmol/L Sample - - 10 µL
STABILITY OF REAGENTS Mix and after a 5 minute incubation read the optical density (OD).
When stored at 2-8° C and protected from light, the reagents The final colour is stable for at least 1 hour.
CALCULATION
PREPARATION AND STABILITY mg/dL n= 2
OF WORKING REAGENTS OD Sample
xn mg/L n= 20
Use only disposable devices OD Standard µmol/L n= 824
Mix 1 volume of reagent 1 with 1 volume of reagent 2. n = standard concentration.
Stability : 24 hours at 20-25°C Take dilution factor into account for the calculation of magne-
4 days at 2-8°C sium concentration in urine.
SAMPLES QUALITY CONTROL

Serum. To ensure adequate quality, control sera such as ELITROL I
Heparin plasma.
mended.
Urine diluted 1/10 with distilled water ; adjust to pH 3-4 with
diluted HCl.
Erythrocytes. LINEARITY
Cerebral spinal fluid (CSF). Up to 5 mg/dL (50 mg/L) (2.03 mmol/L).
REFERENCE VALUES Note : Procedure sheet for erythrocytes is available on request.

Serum, plasma : 1.6 - 2.5 mg/dL
16 - 25 mg/L BIBLIOGRAPHY
0.65 - 1.03 mmol/L
Gindler E. and al., Clin. Chem., 17, (1971), 662.
Cerebral spinal fluid : 2.80 - 3.50 mg/dL
28.00 - 35.00 mg/L SYMBOLS USED ON LABELS:
1.14 - 1.42 mmol/L
Lot Number
Erythrocytes : 5.00 - 6.50 mg/dL
50.00 - 65.00 mg/L Consult instruction for use
2.03 - 2.64 mmol/L
Urine : 50 - 150 mg/24h In vitro diagnostic medical device
2.0 - 6.2 mmol/24h Manufacturer’s address
Note : It is recommended for each laboratory to establish and Temperature limitation
an indication. Expiration date (01/2005)
FTAN-MAGN-3

MAGNESIUM RBCs
(Red Blood Cells)
For in vitro diagnostic use only Ref : MGER - 0400 2 x 50 mL
PRINCIPLE PROCEDURE
Precipitation - Sodium tungstate. Samples must be treated according to the following way :
REAGENTS COMPOSITION 1- Centrifuge blood and eliminate plasma

2- Then , introduce in tubes :
Reagent 1 : R1
Sodium Tungstate 300 mmol/L
Sample standard blank
Reagent 2 : R2
Sulfuric acid 350 mmol/L Distilled water 1.5 mL 1.5 mL 1.6 mL
Standard : Std Treated standard - 100 µL -

Magnesium 50 mg/L
5 mg/dL Pellet 100 µL - -
Mix and let stand tubes for 5 minutes to lyse completely the
2.038 mmol/L
red cells.
Additional Reagent :
3- Add reagent 1, and mix carefully
Kit for Magnesium Calmagite ref. MAGN-0600.
Réactif 1 200 µL 200 µL 200 µL
PRECAUTIONS
4- Add reagent 2, mix, wait for 5 minutes and centrifuge 10
- IRRITANT ! the reagent 2 contains sulfuric acid
minutes at 3000 rpm.
(1.87%).Risk for eyes and skin. Avoid contact with eyes and
skin. In case of contact rinse immediately with plenty of Reagent 2 200 µL 200 µL 200 µL
water and seek a medical device.
5- Measure supernatant with additional reagent
STABILITY OF REAGENTS Supernatant 200 µL 200 µL 200 µL
When stored at 2-8°C and protected from light, the reagent is
stable until the expiry date stated on the label. Additional reagent 2 mL 2 mL 2 mL
SAMPLES Mix and after 5 minuter of incubation read the Optical

Blood collected in heparin. Density (OD) at 540 nm .
REFERENCE VALUES CALCULATION

Erythrocytes : 45.00 - 60.00 mg/L
OD sample x n mg/L n= 50
1.85 - 2.46 mmol/L
OD standard mg/dL n= 5
mol/L n= 2. 038
an indication.
Lot Number
Expiration date
(01/2005)
FTAN-MGER-2

MICROPROTEIN
For in vitro diagnostic use only Ref : PRTP - 0600 2 x 125 mL
METHOD
PROCEDURE
Pyrogallol Red
This reagent can be used manually (see method below) and on
most analysers. The applications are available on request.
PRINCIPLE
Proteins in urine and in cerebral spinal fluid bind pyrogallol Wavelength : 598 nm
red in presence of molybdate and forms a coloured complex. Temperature : 37°C
Reagent : R
Pyrogallol red 60 µmol/L
Sodium molybdate 40 µmol/L Working Reagent 1 mL 1 mL 1 mL
Sodium oxalate 1.04 mmol/L
Sodium benzoate 3.47 mmol/L
Methanol 1 mol/L Standard - 20 µL -
Succinic acid 50 mmol/L Sample - - 20 µL
Standard : Std
Albumin/globulin 100 mg/dL Mix and read the optical density (OD) after a 5 minute incubation.
1 g/L The final colour is stable for at least 1 hour.
PRECAUTIONS
- HARMFUL. The reagent contains methanol (4 %) . Harmful CALCULATION
by inhalation, in contact with skin and if swallowed. OD Sample mg/dL n= 100
- The standard contains less than 0.1 % sodium azide.Sodium xn
OD Standard g/L n= 1
sive metal azides. Regulations currently in use regarding dan- n = standard concentration
gerous waste elimination must be respected. If discharge in
the canalisations, rinse with plenty of water. QUALITY CONTROL
- Use clean or single use glass material only to avoid contami- To ensure adequate quality, urine controls with a normal level
nations. and a pathological level are recommended.
)PERFORMANCES DATA
When stored at 2-8° C and protected from light, the reagent analyser (37°C).
label. • Linearity
The reagent is linear up to 200 mg/dL (2 g/L).
• Detection limit
According to the SFBC, the detection limit is equal to 4
SAMPLES mg/dL (0.04 g/L).
Urine. • Precision : Between-run
Cerebral Spinal Fluid (CSF).
CSF
n = 8 CV = 4 %
REFERENCE VALUES
Normal urine
Urine : 10 - 140 mg/24 h
n = 8 CV = 6.4 %
Cerebral Spinal Fluid : 80 - 320 mg/L
Pathological urine
)Note : It is recommended for each laboratory to establish n = 8 CV = 5.4 % .../...
and maintain its own reference values. The given data here
are only an indication.
(11/2004)
FTAN-PRTP-4

MICROPROTEIN
)INTERFERENCES
According to SFBC recommendations, some studies have
been performed to determine the level of interference from
different components:
On urine:
Urea: No significant interference up to 20 g/L
Glucose: No significant interference up to 5 g/L
NaCl: No significant interference up to 350 mEq/L
Creatinine: No significant interference up to 2.5 g/L
On CSF:
Haemoglobin: Important interference
Note: Avoid to hemolysed Cerebral Spinal fluid (CSF)

sample
BIBLIOGRAPHY
1.Watanabe Nobuko, Kamei S., Ohkubo A. and Al. - Urinary
Protein as Measured with a Pyrogallol Red-Molybdate
Complex, Manually and a Hitachi 726 Automated Analyser.
Clin. Chem., 32, (1986), 1551.
2.Vassault, A., et al., Protocole de validation de techniques,
SYMBOLS USED ON LABELS
Lot number
Expiration date
(11/2004)
FTAN-PRTP-4

PAL (DEA) SL
Ref : PASL - 0400 2 x 62.5 mL

Ref : PASL - 0420 4 x 62.5 mL
For in vitro diagnostic use only Ref : PASL - 0500 5 x 125 mL

Kinetic determination of the Alkaline phosphatase based upon Serum : 25°C 30°C 37°C
DGKC and SCE recommendations : Children U/L : 110 - 720 145 - 950 180 - 1200
Adults U/L : 60 - 170 80 - 220 100 - 290
ALP
p-Nitrophenylphosphate + H2O p-Nitrophenol + Note : It is recommended for each laboratory to establish and
Inorganic phosphate maintain its own reference values. The given data here are only
an indication.
ALP = Alkaline phosphatase
REAGENTS COMPOSITION PROCEDURE

Reagent 1 : R1 on most analysers.
Diethanolamine buffer, pH 10.2 1.25 mol/L The applications are available on request.
Magnesium Chloride 0.625 mmol/L
Wavelength : 405 nm (410)
Reagent 2 : R2 Temperature : 37°C, 30°C, 25°C
p-Nitrophenylphosphate 50 mmol/L Cuvette : 1 cm light path
PRECAUTIONS • One-reagent procedure
HARMFUL ! Reagent 1 contains diethanolamine. Danger of
serious damage to health by prolonged exposure if swallowed. Working reagent : 1 mL
Risk of serious damage of eyes. Wear suitable protective clo- Sample : 20 µL
thing and eye/face protection. Avoid contact with eyes. In case
of contact with eyes , rinse immediately with plenty of water Mix and after a 1 minute incubation, measure the change of
and seek medical device. optical density per minute (∆OD/min.) during 3 minutes.
Avoid direct exposure to light. • Two-reagent procedure
(pipette, plastic vial for analysers...). Reagent 1 : 1 mL
Discard cloudy reagent. Sample : 20 µL
STABILITY OF REAGENT Mix and wait 1 minute

When stored at 2-8° C and protected from light, the reagents Reagent 2 : 250 µL
PREPARATION AND STABILITY optical density per minute (∆OD/min.) during 3 minutes.
CALCULATION
Mix 4 volumes of reagent 1 with 1 volume of reagent 2. • One-reagent procedure
Stability : 5 days at 20-25 °C 405 nm : Activity (U/L) = ∆OD/min. x 2 750
4 weeks at 2-8 °C 410 nm : Activity (U/L) = ∆OD/min. x 2 910
• Two-reagent procedure • Two-reagent procedure
The reagents are ready for use. 405 nm : Activity (U/L) = ∆OD/min. x 3424
410 nm : Activity (U/L) = ∆OD/min. x 3623
SAMPLES
Heparin plasma QUALITY CONTROL
mended.
.../...
(01/2005)
FTAN-PASL-3

PAL (DEA) SL
LINEARITY
If ∆OD/min. exceeds 0.250 at 405 nm, repeat the test using
serum diluted 1/10 with sodium chloride solution (9 g/L).
BIBLIOGRAPHY
1.Scandinavian Society for Clinical Chemistry, Committee on
Enzymes, Recommended methods for the determination of
four enzymes in blood. Scand. J. Clin. Lab. Invest. 33, 291
(1974).
2.German Society for Clinical Chemistry, Standard method for
determination of alkaline phosphatase (AP) activity. J. Clin.
Chem. Clin. Biochem. 10, 290 (1972).
Lot number
Expiration date
(01/2005)
FTAN-PASL-3

ALKALINE
P HPAL
O S P (DEA)
H ATA S E
Ref : PALC - 0030 20 x 3 mL

For in vitro diagnostic use only Ref : PALC - 0200 12 x 20 mL
PRINCIPLE PROCEDURE
Kinetic determination of the alkaline phosphatase based upon This reagent can be used manually (see method below) and
DGKC and SCE recommendations : on most analysers.
ALP The applications are available on request.
p-Nitrophenylphosphate + H2O p-Nitrophenol Wavelength : 405 nm (410)
+Inorganic phosphate Temperature : 25°C, 30°C, 37°C
ALP = Alkaline phosphatase Read against distilled water.
Reagent 1 : R1 Sample : 20 µL
Diethanolamine buffer, pH 10.2 1 mol/L
Magnesium Chloride 0.5 mmol/L
p-Nitrophenylphosphate 10 mmol/L
CALCULATION
pH of the working reagent 9.80 405 nm : Activity (U/L) = ∆OD/min. x 2 750
PRECAUTIONS
HARMFUL ! Reagent 1 contains diethanolamine. Danger of QUALITY CONTROL
serious damage to health by prolonged exposure if swallowed. To ensure adequate quality, control sera such as ELITROL I
Risk of serious damage of eyes. Wear suitable protective clo- (normal control) and ELITROL II (abnormal control) are recom-
thing and eye/face protection. Avoid contact with eyes. In case mended.
of contact with eyes , rinse immediately with plenty of water
and seek medical device. LINEARITY
The reagent 1 contains less than 0.1 % sodium azide. If ∆OD/min. exceeds 0.250 at 405 nm, repeat the test using
Avoid direct exposure to light. serum diluted 1/10 with sodium chloride solution (9 g/L).
When stored at 2-8° C and protected from light, the reagents BIBLIOGRAPHY
are stable until the expiry date stated on the label. Z. Klin. Chem. U. Klin. Biochem, 8, (1970), 658, 10, (1972),
182.
OF WORKING REAGENT SYMBOLS USED ON LABELS :
Stability : 24 hours at 20-25°C Lot number
7 days at 2-8°C
SAMPLES In vitro diagnostic medical device
Heparin plasma. Manufacturer’ s address
REFERENCE VALUES
Expiration date
25°C 30°C 37°C
Children 110 - 720 U/L 145 - 950 U/L 180 - 1200 U/L
Adults 60 - 170 U/L 80 - 220 U/L 100 - 290 U/L

an indication.
(01/2005)
FTAN-PALC-3

PHOSPHORUS
For in vitro diagnostic use only Ref : PHOS - 0600 2 x 125 mL
CLINICAL SIGNIFICANCE (1) - Storage

The main part of phosphorus of the human body (80 to 85 %) Acidified urines are stable for 6 months.
is located in bones. The remaining phosphorus is mainly Plasma and serum are stable at 4°C for 1 week, frozen for seve-
inorganic phosphate. Usually, there is a relationship between ral months.
calcium and phosphate in human serum. An increase of one
of these components usually leads to a decrease of the other REFERENCE VALUES (1)
component. An elevation of serum phosphate can occur in Serum: 2.7 - 4.5 mg/dL
vitamin D intoxication, hypoparathyroïdism and renal failure. 27 - 45 mg/L
A decrease of serum phosphate is bound to vitamin D defi-
0.87 - 1.45 mmol/L
ciency and hyperparathyroidism.
Urine : 400 -1300 mg/24h
METHOD 12.9 - 42.0 mmol/24h
Phosphomolybdate.
U.V. End point. Note : It is recommended for each laboratory to establish and
PRINCIPLE (2)
an indication.
Determination of inorganic phosphorus is made according to
the following reaction : PROCEDURE
Phosphorus
Ammonium molybdate + Sulfuric acid Phosphomolyb-
on most analysers. The applications are available on request.
date complex
REAGENT COMPOSITION Wavelength : 340 nm

Reagent : R
Temperature : 37°C
Sulfuric acid 210 mmol/L Cuvette : 1 cm light path
Ammonium molybdate 650 µmol/L
Standard : Std BLANK STANDARD SAMPLE
Phosphorus 5 mg/dL
50 mg/L
1.62 mmol/L
)PRECAUTIONS Standard - 10 µL -
- The reagent contains sulfuric acid. It is irritant (Xi). Sample - - 10 µL
R36/38: Irritating to eyes and skin.
S26 : In case of contact with eyes, rinse immediately Mix and read the optical density (OD) after a 5 minute incubation.
with plenty of water and seek
medical advice.
S37/39: Wear suitable gloves and eye/face protection.
- Use clean or single use glass material only to avoid conta- CALCULATION
minations. OD Sample mg/dL n= 5
xn mg/L n= 50
STABILITY OF REAGENTS OD Standard mmol/L n= 1.62
When stored at 2-8° C and protected from light, the reagent is
Take dilution factor into account for the calculation of phos-
PREPARATION AND STABILITY phorus concentration in urine.
OF WORKING REAGENT
The reagent is ready for use. )CALIBRATION
Phosphorus standard is traceable to the Standard Reference
)SAMPLES (3,4) Material SRM 186Ig.
- Specimen On Cobas Mira, calibration must be performed at least every
Serum free of hemolysis from fasting patient. 5 days, after each change of batch and according to quality control
results.
Heparinized plasma.
.../...
Urine to acidify (pH<3) after collection and to dilute at 1/10
with distilled water before analysis (when there is no predilu- (04/2004)
tion by the analyser). FTAN-PHOS-6

PHOSPHORUS
QUALITY CONTROL Ascorbic Acid : No significant interference up to 20 mg/dL

(200 mg/L, 1.1 mmol/L)
(normal control) and ELITROL II (abnormal control) are recom- Haemoglobin : Positive bias from 150 mg/dL (1.5 g/L).
mended.
Glucose : No significant interference up to 550 mg/dL (5.5
g/L, 29.7 mmol/L).
PERFORMANCE DATA
The following data were obtained using the COBAS MIRA Turbitidy : Positive bias from 250 mg/dL Triglycerides equiva-
analyser (37°C) lent (2.5 g/L, 2.87 mmol/L).
Calcium : No significant interference up to 100 mg/dL (1 g/L,
- Analytical range 25 mmol/L).
The reagent is linear from 2 to 20 mg/dL (20 to 200 mg/L), Magnesium : No significant interference up to 10 mg/dL
(0.65 to 6.5 mmol/L). (100 mg/L, 4.12 mmol/L).
Iron : No significant interference up to 1 mg/dL (10 mg/L, 0.18
mmol/L).
equal to 0.84 mg/dL (8.4 mg/L), (0.27 mmol/L).
)BIBLIOGRAPHY
1.Endres, D.B., Rude, R.K., Mineral and bone metabolism.
- Sensitivity
Tietz Fundamentals of Clinical Chemistry, Burtis, C.A. et
The average variation of the analytical signal is 49 × 10-3 ∆A
per mg/dL of phosphorus (or 4.9 × 10-3 ∆A per mg/L, Ashwood, E.R. (W.B. Saunders eds. Philadelphia USA), (2001),
0.152 ∆A per mmol/L) for a light path of 1 cm. 795.
2.Daly J.A., Ertingshausen G., Direct method for determining
- Precision inorganic phosphorus in serum with the Centrifichem. Clin.
Within-run Chem., (1972), 18, 263.
Normal serum : Abnormal serum : 3.Tietz, N.W. Clinical guide to laboratory tests, 3th Ed, (W.B.
n = 10 n = 10 Saunders eds. Philadelphia USA), (1995), 486.
m = 4.12 mg/dL m = 7.99 mg/dL
4.Itani, O., Tsang, R.C., Bone disease. Clinical Chemistry:
CV = 1.59 % CV = 2.23 %
Theory, Analysis, Correlation, 4th Ed., Kaplan, L.A, Pesce,
Between-run A.J., Kazmierczak, S.C., (Mosby Inc. eds St Louis USA), (2003),
Normal serum : Abnormal serum : 507.
n = 19 n = 20
m = 4.46 mg/dL m = 8.71 mg/dL
CV = 2.8 % CV = 2.3 %
- Correlation
method and another commercial reagent on 36 human serum
Lot Number
samples. Sample concentrations were between 1.85 and 26.1
mg/dL. The parameters of linear regression are as follows Consult instruction for use
Linear regression : y = 1.0540 x - 0.327 mg/dL
- Interferences (5)
According to SFBC recommendations, some studies have been
performed to determine the level of interference from different Expiration date
compounds:
Unconjugated Bilirubin : Positive bias from 12 mg/dL of biliru
bin (120 mg/L, 205 µmol/L).
Conjugated bilirubin : No significant interference up to 21
(04/2004)
FTAN-PHOS-6

TOTAL PROTEIN
Ref : PRTB - 0600 2 x 125 mL

For in vitro diagnostic use only Ref : PRTB - 0700 4 x 250 mL
CLINICAL SIGNIFICANCE (1-3)

In human plasma, albumin accounts for 50 to 60% of total OF WORKING REAGENT
proteins; the remainder fraction mainly contains globulins (α1,
The reagent is ready for use
α2, ß et γ). Most plasmatic proteins are synthesized by the
liver, except immunoglobulins. SAMPLES (2-3)
Increase of the plasmatic volume (salt retention syndrome,
intoxication with water…) or its reduction (dehydration related - Specimen
to vomiting, diarrhoea…) induce respectively relative hypopro- Serum free from haemolysis and lipemia
teinemia and relative hyperproteinemia.
Abnormal total protein rates only occur in the event of disor- - Storage
der affecting the concentration of albumin and immunoglobu- Serum are stable for 72 hours at 4°C and at least 2 months at
lins. Thus, severe proteinic insufficiency (malabsorption, mal- -20°C. For longer storage, freeze samples at -70°C.
diges-tion, dietary insufficiency), renal and hepatic diseases
result in hypoproteinemia. If total protein concentration is REFERENCES VALUES (3)
lower than 40 g/L oedemas can be observed. Ambulatory patients Patients at rest
Hyperproteinemia can be seen, for example, in case of hyper- 6.4 - 8.3 g/dL 6.0 - 7.8 g/dL
immunoglobulinemia (multiple myeloma, infection).
64 - 83 g/L 60 - 78 g/L
METHOD (4-5)
Biuret reaction Note : It is recommended for each laboratory to establish and

End point maintain its own reference values. The given data here are only
an indication.
PRINCIPLE (4-5)
PROCEDURE
Serum proteins form a coloured complex in the presence of
copper salt in alkaline solution.
most analysers. The applications are available on request.
Proteins + Cu 2+ Colored complex

Wavelength : 550 nm
Temperature : 37°C
REAGENTS COMPOSITION Cuvette : 1 cm light path
Reagent : R Read against reagent blank.
Potassium iodide 6 mmol/L
Potassium sodium tartrate 21 mmol/L BLANK STANDARD SAMPLE
Copper sulfate 6 mmol/L
Sodium hydroxide 58 mmol/L
Standard : Std Standard - 10 µL -
Albumin 6 g/dL Sample - - 10 µL
60 g/L
Mix and read the optical density (OD) after a 10 minutes
PRECAUTIONS incubation.
- The standard contain less than 0.1 % sodium.azide. Sodium
azide can react with copper and lead plumbing to form explo- CALCULATION
sive metal azides.
OD Sample g/dL n= 6
Regulations currently in use regarding dangerous waste elimi- xn
nation must be respected. If discharge in the canalisations, OD Standard g/L n= 60
rinse with plenty of water.
minations.
CALIBRATION
Protein standard is traceable to the Standard Reference
Material, NIST SRM 927c.
When stored at 2-8° C and protected from light, the reagent
.../...
label. (08/2004)
FTAN-PRTB-3

TOTAL PROTEIN
QUALITY CONTROL - Interférences (6)

To ensure adequate quality, control sera such as ELITROL I According to SFBC recommendations, some studies have been
(normal control) and ELITROL II (abnormal control) are recom- performed to determine the level of interference from different
mended. compounds:
Bilirubin : No significant interference up to
PERFORMANCE DATA 30 mg/dL , (300 mg/L, 510 µmol/L).
Haemoglobin : Positive bias from 300 mg/dL
analyser (37°C)
(3 g/L).
- Analytical range
500 mg/dL (5 g/L, 27 mmol/L).
The reagent is linear from 0.2 to 10 g/dL ( 2 to 100 g/L).
Turbidity : Positive bias from 250 mg/dL
- Detection limit (6) Triglycerides equivalent ( 2.5 g/L,
Determined according to SFBC protocol, the detection limit is 2.87 mmol/L) .
equal to 0.07 g/dL (0.7 g/L).
BIBLIOGRAPHY
- Sensibility 1.Christensen, S.E., Proteins. Clinical Chemistry: Concepts
and Application, Anderson, S.C., Cockayne, S. (W.bSaunders
The average variation of the analytical signal is 31 x 10 -3 ∆A
eds. Philadelphia USA), (1983), 188.
per g/dL of total protein (3.1 x 10 -3 ∆A per g/L) for a light
path of 1 cm. Analysis, Correlation, 4th Ed., Kaplan, L.A, Pesce, A.J.,
Kazmierczak, S.C., (Mosby Inc. eds St Louis USA), (2003),
- Precision 492.
Within-run reproducibility 3.Tiez, N.W., Clinical guide to laboratory tests. 3th Ed, (W.B.
Low level : Saunders eds. Philadelphia USA), (1995), 518.
n = 10 m = 3.69 g/dL CV = 1.53 % 4.Gornall A. et al., Determination of serum proteins by means
of the biuret reaction, J. Biol. Chem., (1949), 177, 751.
Medium level :
n = 10 m = 6.76 g/dL CV = 1.24 % 5.Doumas, B.T., et al., A candidate reference method for
determination of total protein in serum. I. Development and
validation II. Test for transferability. Clin. Chem., (1981), 27,
Between-run reproducibility 1642.
Low level : 6.Vassault, A., et al., Protocole de validation de techniques,
n = 10 m = 3.81 g/dL CV = 4.65 % (Document B, stade 3). Ann. Biol. Clin., (1986), 44, 686.
Medium level :
n = 10 m = 6.99 g/dL CV = 1.92 %
- Correlation
A comparative study has been performed between Elitech Lot Number
samples. The sample concentrations were between 1.38 and Consult instruction for use
14.29 g/dL.
The parameters of linear regression are as follows : In vitro diagnostic medical device
Linear regression : y = 0.96 x + 0.18 g/dL
Expiration date
(08/2004)
FTAN-PRTB-3

TRIGLYCERIDES
MONO SL NEW
Ref. TGML - 0425 6 x 50 mL

Ref. TGML - 0515 6 x 100 mL
For in vitro diagnostic use only Ref. TGML - 0700 4 x 250 mL
CLINICAL SIGNIFICANCE (1-2) STABILITY OF REAGENT

Triglycerides constitute 95% of tissue storage fat and their When stored at 2-8° C and protected from light, the reagent is
main role is to provide energy for the cell. They are synthesi- stable until the expiry date stated on the label.
zed both in the intestine from dietary fats and in liver from die-
tary carbohydrates, and are then transported in blood by chy- WORKING REAGENT
lomicrons and VLDL. The reagent is ready for use.
High serum triglyceride levels are associated with important
risks of atherosclerosis. They can be due to diseases like diffe- SAMPLES (4)
rent lipid metabolism disorders (hyperlipoproteinemia, lipase
activity deficiency, apolipoprotein C-II deficiency), but also to - Specimen
diabetes, renal or endocrine disorders. Serum and heparin or EDTA plasma from fasting patients.
Collect the samples in tubes and stoppers free of glycerol.
METHOD (3)
- Storage
Enzymatic-colorimetric.
Samples are stable 5 to 7 days if stored at 2-8°C, 3 months at
End point. -15 to -20°C and several years at -70°C.
PRINCIPLE (3) REFERENCE VALUES (2)

Enzymatic determination of triglycerides according to the fol-
has established the following classification for serum triglyce-
lowing reactions :
LPL ride levels according to the risk of developing coronary heart
Triglycerides + H20 Glycerol + Fatty acids diseases:
Glycerol kinase Normal < 150 mg/dL
Glycerol + ATP Glycerol-3-Phosphate + ADP Borderline high 150-200 mg/dL
GPO High 200-500 mg/dL
Glycerol-3-Phosphate + 02 Dihydroxyacetone-P + H202 Very high ≥ 500 mg/dL
Peroxidase Note : It is recommended for each laboratory to establish and
H202 + 4-AAP + p-Chlorophenol Quinoneimine maintain its own reference values. The data given here are only
an indication.
4-AAP = Amino-4-antipyrine
LPL = Lipoprotein Lipase )PROCEDURE
GPO = Glycerol-3-phosphate oxidase
This reagent can be used on most analysers. The applications
REAGENT COMPOSITION
Reagent : R Wavelength : 500 nm
Temperature : 37°C
Mg2+ 14.8 mmol/L Read against reagent blank.
p-Chlorophenol 2.7 mmol/L
ATP 3.15 mmol/L
Potassium ferrocyanide 10 µmol/L
Distilled water 3 µL
Amino-4-antipyrine 0.31 mmol/L
Standard 3 µL
Lipoprotein lipase ≥ 2 000 U/L
Sample 3 µL
Glycerol kinase ≥ 500 U/L
Glycerol-3-phosphate oxidase ≥ 4 000 U/L Mix and read the absorbances (A) after a 425 seconds incuba-
tion.
Peroxidase ≥ 500 U/L
CALCULATION
PRECAUTIONS Asample
- This reagent contains less than 0.1 % sodium azide. Sodium xn n = standard concentration
azide can react with copper and lead plumbing to form explo- Astandard
sive metal azides. Regulations currently in use regarding dan-
the canalisations, rinse with plenty of water. .../...
contaminations.
(01/2005)
FTAN-TGMLN-8

TRIGLYCERIDES
MONO SL NEW
CALIBRATION - Interferences (5)
On Cobas Mira, calibration must be performed at least every According to SFBC recommendations, studies have been per-
2 weeks, and after each change of batch, or quality control formed to determine the level of interference from different
compounds:
results.
Total Bilirubin : Negative bias from 25 mg/dL (250 mg/L, 430
µmol/L).
QUALITY CONTROL
To ensure adequate quality, control sera such as ELITROL I Conjugated Bilirubin : Negative bias from 15 mg/dL (150
(normal control) and ELITROL II (abnormal control) are recom- mg/L, 250 µmol/L).
mended. Ascorbic acid : No significant interference up to 2 mg/dL (20
mg/L, 0.11 mmol/L).
PERFORMANCE DATA Haemoglobin : Positive bias from 0.25 g/dL (2.5 g/L).
The following data were obtained using the COBAS MIRA Glucose : No significant interference up to 500 mg/dL (5.0
analyser (37°C). g/L, 28 mmol/L).
Uric acid : No significant interference up to 22 mg/dL (220
- Analytical range mg/L, 1.3 mmol/L).
The reagent is linear from 25 to 1000 mg/dL (0.25 to 10 g/L),
(0.3 to 11.5 mmol/L).
BIBLIOGRAPHY
- Detection limit (5) 1. Naito, H.K., Coronary Artery Disease and Disorders of Lipid
Determined according to SFBC protocol, the detection limit is Metabolism. Clinical Chemistry: Theory, Analysis, Correlation,
equal to 5 mg/dL (0.05 g/L, 0.06 mmol/L). 4th Ed., Kaplan, L.A., Pesce, A.J., Kazmierczak, S.C. (Mosby,
Inc. eds. St Louis USA), (2003), 603.
- Sensitivity 2.Expert Panel on Detection, Evaluation, and Treatment of
The average variation of the analytical signal is 1.0 × 10-3 ∆A High Blood Cholesterol in Adults (Adult Treatment Panel III),
per mg/dL of Triglycerides (or 100 × 10-3 ∆A per g/L, 88 m∆A Executive Summary of the Third Report of the National
per mmol/L) for a light path of 1 cm. Cholesterol Education Program (NCEP). JAMA, (2001), 285,
2486.
- Precision 3.Fossati, P., Prencipe, L., Serum triglycerides determined colo-
rimetrically with an enzyme that produces hydrogen peroxide.
Clin. Chem., (1982), 28, 2077.
Medium level : n = 20 m = 114 mg/dL CV = 1.3 % 4.Tietz, N.W., Clinical guide to laboratory tests, 3rd Ed. (W.B.
High level : n = 20 m = 278 mg/dL CV = 1.4 % Saunders eds. Philadelphia USA), (1995), 610.
Between-run reproducibility (Document B, stade 3) Ann. Biol. Clin., (1986), 44, 686.
- Correlation
Lot number
samples. The sample concentrations were between 20 and
1050 mg/dL. The parameters of linear regression are as fol- In vitro diagnostic medical device
lows :
Linear regression : y = 0.943 x + 9 mg/dL Expiration date
(01/2005)
FTAN-TGMLN-8

TRIGLYCERIDES
Ref : TRIG - 0200 12 x 20 mL

Ref : TRIG - 0400 9 x 50 mL
For in vitro diagnostic use only Ref : TRIG - 0500 6 x 100 mL

Enzymatic determination of triglycerides according the follo- Male : 60 - 165 mg/dL
wing reactions : 0.60 - 1.65 g/L
Lipoprotein lipase 0.68 - 1.88 mmol/L
Triglycerides + H20 Glycerol + Fatty acid
Female : 40 - 140 mg/dL
Glycerol kinase
Glycerol + ATP Glycerol-3-Phosphate + ADP 0.40 - 1.40 g/L
0.46 - 1.60 mmol/L
Mg++
GPO Note : It is recommended for each laboratory to establish and
Glycerol-3-Phosphate + 02 Dihydroxyacetone phosphate +H202
Peroxidase an indication.
2H202 + 4-Aminoantipyrine + ADPS Red quinone + 4H20
GPO = Glycerol-3-phosphate Oxidase.

PROCEDURE
ADPS = N-Ethyl-N-sulfopropyl-n-methoxyaniline. on most analysers.
Pipes buffer, pH 7.50 50 mmol/L Cuvette : 1 cm light path
ADPS 1 mmol/L Read against reagent blank.
Magnesium salt 15 mmol/L
Lipoprotein lipase ≥ 1 100 U/L Working Reagent 1 mL 1 mL 1 mL

Glycerol kinase ≥ 800 U/L
Glycerol-3-Phosphate oxidase ≥ 5 000 U/L Distilled water 10 µL - -
Peroxidase ≥ 350 U/L Standard - 10 µL -
Sample - - 10 µL
ATP 0.3 mmol/L
Standard : Std Mix and read the optical density (OD) after a 5 minute incubation.
Glycerol (Triglycerides equivalent) 200 mg/dL The final colour is stable for at least 30 minutes.
2 g/L
2.28 mmol/L
CALCULATION
PRECAUTIONS
The reagent 1 and the standard contain less than 0.1 % xn g/L n= 2
sodium azide. OD Standard mmol/L n= 2.28
STABILITY OF REAGENTS n = standard concentration
are stable until the expiry date stated on the label. QUALITY CONTROL
PREPARATION AND STABILITY (normal control) and ELITROL II (abnormal control) are recom-
mended.
OF WORKING REAGENT
6 weeks at 2-8°C
SAMPLES
Serum.
Heparin plasma.
(01/2005)
FTAN-TRIG-2

TRIGLYCERIDES
LINEARITY
Up to 1 000 mg/dL (10 g/L) (11.4 mmol/L).
BIBLIOGRAPHY
1.Buccolo G., David M., Clin. Chem., 19, (1973), 476.
2.Werner M., Gabrielson D.G., Eastman G., Clin Chem., 21,
(1981), 268.
3.Annoni G., Bottasso B.M., Ciaci D., Donato M.F., Tripoli A.,
lab. J.J. Res. Lab. Med., 9, (1982), 115.
Lot number
Expiration date
(01/2005)
FTAN-TRIG-2

UREA C O L O R
For in vitro diagnostic use only Ref : URCO - 0605 3 x 125 mL
PRINCIPLE SAMPLES
Enzymatic determination of urea according the following reaction : Serum.
Urease Heparin plasma.
Urea + H2O 2NH3 + CO2 Urine diluted 1/100 in distilled water.
(Do not use anticoagulants containing fluoride or ammonium ions).
In an alkaline medium, in the presence of salicylate and sodium
hypochlorite, ammonium ions react to produce a green compound.
REFERENCE VALUES
REAGENTS Serum, plasma : 15 - 50 mg/dL
0.15 - 0.50 g/L
Reagent 1 : R1 2.50 - 8.33 mmol/L
Urease ≥ 30 000 U/L Urine : 20 - 35 g/24 h
Phosphate buffer, pH 6.70 120 mmol/L 333 - 583 mmol/24 h
Sodium Salicylate 60 mmol/L
Sodium nitroprussiate 3.5 mmol/L Note : It is recommended for each laboratory to establish and
EDTA 1.34 mmol/L
an indication.
Reagent 2 : R2
Sodium hypochlorite 45 mmol/L PROCEDURE
Sodium hydroxyde 1 mol/L This reagent can be used manually (see method below) and
Standard : Std on most analysers.
Urea 50 mg/dL
0.5 g/L Wavelength : 578 nm
8.325 mmol/L Temperature : 37°C
PRECAUTIONS Read against reagent blank.

The reagent 1 contains less than 0.1 % sodium azide. BLANK STANDARD SAMPLE
The reagent 2 contains sodium hydroxide, known as highly
caustic. Avoid contact with skin and mucous membranes. If WR 1 1 mL 1 mL 1 mL
spilt, wash thoroughly with water. Distilled water 10 µL - -
Standard - 10 µL -
When stored at 2-8° C and protected from light, the reagents Sample - - 10 µL
are stable until the expiry date stated on the label. Mix and incubate for 3 minutes, then add :
PREPARATION AND STABILITY WR 2 1 mL 1 mL 1 mL

OF WORKING REAGENTS Mix and read optical density (OD) after a 5 minute incubation.
WR 1 : Dissolve the reagent 1 in the suitable volume of distilled The final colour is stable for at least 30 minutes.
water.
Stability : 4 days at 20-25°C CALCULATION
3 weeks at 2-8°C OD Sample mg/dL n= 50
xn g/L n= 0.5
WR 2 : Dilute the reagent 2 with 100 mL of distilled water OD Standard mmol/L n = 8.325
(1 volume + 4 volumes).
Stability : 3 months at 2-8°C n = standard concentration.
Take the dilution factor into account for the calculation of urea
(01/2005)
FTAN-URCO-2

UREA C O L O R
QUALITY CONTROL
mended.
LINEARITY
BIBLIOGRAPHY
1.Chaney, A.L., Clinical Chem. and al., 8, (1962), 130.
2.Reiss. D. and al., Bull. Soc. Pharm. Bordeaux, 104, (1965),
Lot number
Expiration date
(01/2005)
FTAN-URCO-2

UREA UV SL
Ref.: URSL - 0400 2 x 62.5 mL

Ref.: URSL - 0420 4 x 62.5 mL
For in vitro diagnostic use only Ref.: URSL - 0500 5 x 125 mL

Urea is the major metabolite product of protein catabolism. • One-reagent procedure
The biosynthesis of urea from ammonia is exclusively carried
Mix 4 volumes of reagent R1 with 1 volume of reagent R2.
out by hepatic enzymes. More than 90% of urea is excreted
through the kidneys, with the remainder excreted through the Stability : 5 days at 20-25°C
gastrointestinal tract or skin. 4 weeks at 2-8°C
Blood urea concentrations can be increased by numerous fac- • Two-reagent procedure
tors linked to prerenal causes (increased protein catabolism,
as in haemorrhage into gastrointestinal tract, shock, some
chronic liver diseases) or renal/postrenal causes (acute or SAMPLES (2,3)
chronic renal diseases, postrenal obstruction to urine flow). - Specimen
Uremia is also increased by high-protein diet, state of dehy- -Serum or heparinized plasma (except ammonium heparin).
dratation, muscle wasting (as in starvation). The determina- Do not use fluoride as inhibitor of glycolysis since it inhibits
tion of urea rate is used together with the determination of urease.
creatinin rate to discriminate between prerenal (normal creati- -Urines should be diluted at 1/20 to 1/50 with distilled water
nin) and renal/postrenal (increased creatinin) disorders. before analysis (when there is no predilution by the analyser).
METHOD (3-5) - Storage

Enzymatic - UV Serum and plasma are stable up to 24 hours at room tempe-
Kinetic rature, for one week at 4°C. Frozen between -15 and -20°C,
these samples are stable for at least 2-3 months.
PRINCIPLE (3-5) Urine samples are stable up to 4 days if stored at 4-8°C.
Enzymatic determination according to the following reactions: Urines can be preserved with thymol to avoid bacterial action
Urease or by maintaining the pH below 4.
Urea + 2H20 2NH4+ + CO32-
REFERENCE VALUES (1,2)
GlDH
NH4++ α-Ketoglutarate + NADH L-Glu +NAD+ + H20 Urea BUN
Serum, plasma: 13 - 43 6 - 20 mg/dL
L-Glu = L-Glutamate 0.13 - 0.43 0.06 - 0.2 g/L
GlDH = Glutamate dehydrogenase 2.1 - 7.1 2.1 - 7.1 mmol/L
REAGENTS COMPOSITION Urine: 26 - 43 12 - 20 g/24 h

430 - 710 430 - 710 mmol/24 h
Reagent 1 : R1
Tris buffer, pH 7.60 (37°C) 125 mmol/L Note : It is recommended for each laboratory to establish and
ADP 1 mmol/L maintain its own reference values. The given data here are only
α-Ketoglutarate 9 mmol/L an indication.
Urease ≥ 8 100 U/L
GlDH ≥ 1 350 U/L )PROCEDURE
Reagent 2 : R2 This reagent can be used on most analysers. The applications
NADH 1.5 mmol/L
Wavelength : 340 nm
Temperature : 37°C
PRECAUTIONS Read against reagent blank.
- The reagents contain less than 0.1% of sodium azide. Sodium
sive metal azides.
rinse with plenty of water. Standard 3 µL
- Use clean or single use laboratory equipment only to avoid Sample 3 µL
contaminations. Mix and read the variation of absorbance (∆A) between 25
seconds and 75 seconds.
STABILITY OF REAGENTS .../...
are stable until the expiry date stated on the label. (01/2005)
FTAN-URSL-5

UREA UV SL
• Two-reagent procedure The parameters of linear regression are as follows :

BLANK STANDARD SAMPLE Correlation coefficient (r) : 0.999
Reagent R1 200 µL 200 µL 200 µL Linear regression : y = 1.02 x - 0.9 mg/dL
- Interferences (6,7)
Mix and wait 25 seconds: According to SFBC recommendations, some studies have been
performed to determine the level of interference from different
Distilled water 2,5 µL compounds:
Standard 2,5 µL
Sample 2,5 µL Bilirubin: No significant interference up to 60 mg/dL (600
mg/L, 1027 µmol/L).
Mix and read the variation of absorbance (∆A) between 25 Haemoglobin: No significant interference up to 500 mg/dL
seconds and 75 seconds. (5 g/L).
Ascorbic acid: No significant interference up to 23 mg/dL
CALCULATION (230 mg/L, 1.3 mmol/L).
∆Asample Turbidity: No significant interference up to 600 mg/dL
xn n = standard concentration Triglycerides equivalent (6 g/L, 6.9 mmol/L) .
∆Astandard
Glucose: No significant interference up to 500 mg/dL (5 g/L, 28
Take the dilution factor into account for the calculation of urea mmol/L).
concentration in urine. Methyldopa: No significant interference up to 5 mg/dL (50
mg/L)
QUALITY CONTROL
BIBLIOGRAPHY
(normal control) and ELITROL II (abnormal control) are recom- 1.Newman, D.J., Price C.P., Non protein Nitrogen Metabolite. Tietz
mended. Fundamentals of Clinical Chemistry, 5th Ed., Burtis, C.A. &
Ashwood, E.R. (W.B. Saunders eds. Philadelphia USA), (2001), 414.
PERFORMANCE DATA 2.Tietz, N.W., Clinical guide to laboratory tests, 3rd Ed., (W.B.
The following data were obtained using the COBAS MIRA Saunders eds. Philadelphia USA), (1995), 622.
analyser (37°C) 3.First, M.R, Renal function. Clinical Chemistry: Theory, Analysis,
Correlation, 4th Ed., Kaplan, L.A, Pesce, A.J., Kazmierczak, S.C.,
- Analytical range (Mosby Inc. eds St Louis USA), (2003), 477 and appendix.
The reagent is linear from 10 to 300 mg/dL ( 0.1 to 3 g/L, 4.Bretaudière, J.P., et al., Direct Enzymatic Determination of Urea in
1.67 to 50 mmol/L). Plasma and Urine with a Centrifugal Analyzer. Clin. Chem., (1976),
22, 1614.
5.Fawcett, J.K., Scott, J.E., A Rapid and Precise Method for the
Determined according to SFBC protocol, the detection limit is Determination of Urea. J. Clin. Path., (1960), 13, 156.
equal to 5.5 mg/dL (0.055 g/L, 0.92 mmol/L).
6.Vassault, A., et al., Protocole de validation de techniques
- Sensitivity
The average variation of the analytical signal is 1.33 ∆A/min. 7.Vassault, A., et al., Analyses de biologie médicale: spécifications
per mg/dL of urea (0.133 ∆A/min. per g/L, 8 m∆A/min. per et normes d'acceptabilité à l'usage de la validation des techniques.
mmol/L) for a light path of 1 cm. Ann. Biol. Clin. (1999), 57, 685
- Precision
Within-run reproducibility SYMBOLS USED ON LABELS:
Lot Number
Low level : n = 20 m = 29 mg/dL CV = 3.2 % In vitro diagnostic medical device
High level : n = 20 m = 158 mg/dL CV = 4.4 % Manufacturer’s address
- Correlation Temperature limitation

Expiration date
samples. The sample concentrations ranged from 9 to 310 mg/dL. (01/2005)
FTAN-URSL-5

UREA UV
Ref : URUV - 0400 9 x 50 mL

For in vitro diagnostic use only Ref : URUV - 0500 6 x 100 mL
PRINCIPLE PROCEDURE
Enzymatic determination according to the following reactions : This reagent can be used manually (see method below) and
on most analysers.
Urease
Urea + H20 2NH3 + CO2 The applications are available on request.
GlDH
Wavelength : 340 nm
2NH4+ + 2α-Ketoglutarate + 2NADH 2L-Glutamate + Temperature : 37°C, 30° C
2NAD+ + 2H20
GlDH = Glutamate dehydrogenase


Working Reagent 1mL 1 mL 1 mL
Reagent 1 : R1
ADP 0.66 mmol/L
Standard - 10 µL -
GlDH ≥ 1 000 U/L
Urease ≥ 30 000 U/L Sample - - 10 µL
NADH 0.32 mmol/L
Mix and read the variation of optical density (∆OD) between 30
α-Ketoglutarate 9 mmol/L seconds and 90 seconds.
Reagent 2 : R2
Tris buffer, pH 7.55 75 mmol/L CALCULATION
∆OD Sample mg/dL n= 50
Standard : Std
xn g/L n = 0.50
Urea 50 mg/dL ∆OD Standard mmol/L n = 8.325
0.5 g/L
8.325 mmol/L
Take the dilution factor into account for the calculation of urea
PRECAUTIONS concentration in urine.
The reagent 2 and the standard contain less than 0.1 %
sodium azide. QUALITY CONTROL
STABILITY OF REAGENTS (normal control) and ELITROL II (abnormal control) are recom-
mended.
LINEARITY
PREPARATION AND STABILITY Up to 300 mg/dL (3 g/L) (50 mmol/L).
OF WORKING REAGENT
Dissolve the reagent 1 in the suitable volume of reagent 2. BIBLIOGRAPHY
Stability : 5 days at 20-25°C Talke H.Schubert G.E., Klin., 43, (1965), 174.
1 month at 2-8°C
SAMPLES
Serum. Lot number
Heparin plasma.
Urine diluted 1/100 in distilled water.
(Do not use anticoagulants containing fluoride or ammonium ions). In vitro diagnostic medical device
REFERENCES VALUES
0.15 - 0.50 g/L Expiration date
2.50 - 8.33 mmol/L
Urine : 20 - 35 g/24 h Temperature limitation (01/2005)
333 - 583 mmol/24 h FTAN-URUV-2

URIC ACID MONO SL
Ref.: AUML - 0420 6 x 50 mL

Ref.: AUML - 0500 6 x 100 mL
Ref.: AUML - 0700 4 x 250 mL

Uric acid is the major product of the catabolism of endogenous When stored at 2-8°C and protected from light, the reagent is
and exogenous (dietary) purine nucleosides (adenosine and stable until the expiry date stated on the label.
guanosine). This transformation mainly occurs in the liver.
Approximatively 75% of uric acid is eliminated by kidneys; the WORKING REAGENT
remainder is secreted into the gastrointestinal tract, where it The reagent is ready for use.
is degraded by bacterial enzymes. Uric acid is not very soluble
in water; urate crystals can occur in urines when the concen- SAMPLES (1,3,5)
tration is abnormally high. It can also happen in plasma, crys- • Specimen
tals then deposite essentially in joints, which induce intense Serum.
inflammatory responses (gout). Some causes for increasing Heparinized plasma.
uric acid rate in serum are: increasing of purines synthesis, Urine diluted 1/10 in distilled water. If unpreserved urine is
metabolic disorders (Lesch-Nyhan syndrome for example), received, add 0.1 mL of 12.5M NaOH to 10 mL of well-mixed
urine; mix well. Warming at 60°C to dissolve precipitate may
nutritional troubles, increasing of nucleic acid turn-over in
be needed.
case of proliferation of tumor cells, leukaemia, psoriasis, cyto-
toxic drugs, renal failures… • Storage
Decreasing of uric acid rate in serum is more uncommon. It Serum and heparinized plasma samples are stable 3 to 5 days
if stored at 4°C, 6 months at -20°C.
can occur in different cases: failure in renal elimination of uric
Urines are stable 3 days at room temperature. Do not refrige-
acid (Fanconi syndrome), Hodgkin's disease for example. rate urine samples.
METHOD (4)
Enzymatic - colorimetric.
Trinder. End point. Serum, plasma: Woman Man

2.6 - 6 3.5 - 7.2 mg/dL
26 - 60 35 - 72 mg/L
PRINCIPLE (4)
155 - 357 208 - 428 µmol/L
Enzymatic determination of uric acid according to the follo-
wing reactions: Urine: 250 - 750 mg/24 h
1500 - 4500 µmol/24 h
Uricase
Uric acid + 2H2O + O2 Allantoine + CO2 + H2O2 Note: It is recommended for each laboratory to establish and
Peroxidase maintain its own reference values. The data given here are only
2H2O2 + 4-AAP + EHSPT Quinoneimine + 4H2O an indication.
EHSPT = N-Ethyl-N-(2-Hydroxy-3-Sulfopropyl) m-Toluidine )PROCEDURE

4-AAP = Amino-4-antipyrine This reagent can be used on most analysers. The applica-
tions are available on request.
Wavelength : 550 nm
Reagent: R Temperature : 37°C
Phosphate buffer, pH 7.0 100 mmol/L Read against reagent blank.
EHSPT 0.72 mmol/L
Ferrocyanide 0.03 mmol/L BLANK STANDARD SAMPLE
Amino-4-antipyrine 0.37 mmol/L Working reagent 200 µL 200 µL 200 µL
Uricase ≥ 150 U/L Distilled water 5 µL
Peroxidase ≥ 12 000 U/L Standard 5 µL
Sample 5 µL
PRECAUTIONS
- Reagent contains less than 0.1 % sodium azide. Sodium Mix and measure the absorbances (A) after 325 second incu-
azide can react with copper and lead plumbing to form explo- bation
sive metal azides. Regulations currently in use regarding dan-
gerous waste elimination must be respected. If discharge in .../...
the canalisations, rinse with plenty of water.
contaminations.
(01/2005)
FTAN-AUML-4

URIC ACID MONO SL
- Interferences (6)
CALCULATION
Asample formed to determine the level of interference from different
xn n = standard concentration compounds:
Astandard
Bilirubin: No significant interference up to 30 mg/dL (300
Take the dilution factor into account for the calculation of uric mg/L, 510 µmol/L)
acid concentration in urine. Haemoglobin: Positive bias from 0.05 g/dL (0.5 g/L).
Glucose: No significant interference up to 0.5 g/dL (5 g/L, 28
QUALITY CONTROL mmol/L).
(normal control) and ELITROL II (abnormal control) are recom- Ascorbic acid: Negative bias from less than 1 mg/dL (10
mended. mg/dL, 0.056 mmol/L).
Turbidity: Positive bias from 370 mg/dL Triglyceride equiva-
PERFORMANCE DATA lent (3.7 g/L, 4.25 mmol/L).
analyser (37°C)
BIBLIOGRAPHY
- Analytical range 1.First, M.R., Renal Function. Clinical Chemistry: Theory,
The reagent is linear from 0.5 to 25 mg/dL (5 to 250 mg/L, 30 Analysis, Correlation, 4th Ed., Kaplan, L.A, Pesce, A.J.,
to 1500 µmol/L). Kazmierczak, S.C., (Mosby Inc. eds St Louis USA), (2003), 477-
appendix.
- Detection limit (6) 2.Newman, D. J., Price, C. P., Non protein Nitrogen Metabolite.
Determined according to SFBC protocol, the detection limit is Tietz Fundamentals of Clinical Chemistry, 5th Ed., Burtis,
equal to 0.2 mg/dL (2 mg/L, 13 µmol/L). C.A. & Ashwood, E.R. (W.B. Saunders eds. Philadelphia USA),
(2001), 414.
- Sensitivity 3.Tietz, N.W., Clinical guide to laboratory tests, 3rd Ed, (W.B.
The average variation of the analytical signal is 21 × 10-3 ∆A Saunders eds. Philadelphia USA), (1995), 624.
per mg/dL of uric acid (2.1 × 10-3 ∆A per mg/L, 350 ∆A per
µmol/L) for a light path of 1 cm. 4.Fossati, P., et al., Use of 3,5-dichloro-2-hydroxy-benzenesul-
fonic acid/4-aminophenazone chromogenic system in direct
- Precision enzymatic assay of uric acid in serum and urine. Clin. Chem.,
Within-run reproducibility (1980), 26, 227.
Medium level: n = 10 m = 4.5 mg/dL CV = 1.0 % 5.Kaplan, L.A., Pesce, A.J., Examination of Urine. Clinical
High level: n = 10 m = 11 mg/dL CV = 0.7 % Chemistry: Theory, Analysis, Correlation, 4th Ed., Kaplan, L.A,
Pesce, A.J., Kazmierczak, S.C., (Mosby Inc. eds St Louis USA),
(2003), 1092.
6.Vassault, A., et al., Protocole de validation de techniques
Medium level: n = 18 m = 4.8 mg/dL CV = 1.8 % (Document B, stade 3). Ann. Biol. Clin., (1986), 44, 686.
High level: n = 18 m = 8.9 mg/dL CV = 2.7 %

method and another commercial reagent on 42 human serum Lot Number
samples. The sample concentrations were between 1.9 and 29
mg/dL. Consult instruction for use
The parameters of linear regression are as follows :
Correlation coefficient (r): 0.9985
Linear regression: y = 1.003 x + 0.43 mg/dL Manufacturer’s address
Expiration date
(01//2005)
FTAN-AUML-4

URIC ACID SL
Ref.: AUSL - 0400 2 x 62.5 mL

Ref.: AUSL - 0420 4 x 62.5 mL
For in vitro diagnostic use only Ref.: AUSL - 0600 5 x 125 mL

Uric acid is the major product of the catabolism of endogenous When stored at 2-8°C and protected from light, reagents are
and exogenous (dietary) purine nucleosides (adenosine and stable until the expiry date stated on the label.
guanosine). This transformation mainly occurs in the liver.
Approximatively 75% of uric acid is eliminated by kidneys; the
OF WORKING REAGENT
remainder is secreted into the gastrointestinal tract, where it
is degraded by bacterial enzymes. Uric acid is not very soluble • One-reagent procedure
in water; urate crystals can occur in urines when the concen- Mix 4 volumes of reagent R1 with 1 volume of reagent R2.
tration is abnormally high. It can also happen in plasma, Stability: 2 weeks at 20-25°C
crystals then deposite essentially in joints, which induce 1 month at 2-8°C
intense inflammatory responses (gout). Some causes for • Two-reagent procedure
increasing uric acid rate in serum are: increasing of purines Reagents are ready for use.
synthesis, metabolic disorders (Lesch-Nyhan syndrome for
example), nutritional troubles, increasing of nucleic acid turn- SAMPLES (1,3,5)
over in case of proliferation of tumor cells, leukaemia, psoria- • Specimen
sis, cytotoxic drugs, renal failures… Serum.
Decreasing of uric acid rate in serum is more uncommon. It Heparinized plasma.
Urine diluted 1/10 in distilled water. If unpreserved urine is
can occur in different cases: failure in renal elimination of uric
received, add 0.1 mL of 12.5M NaOH to 10 mL of well-mixed
acid (Fanconi syndrome), Hodgkin's disease for example.
urine; mix well. Warming at 60°C to dissolve precipitate may
be needed.
METHOD (4)
Enzymatic - colorimetric. • Storage

Trinder. End point. Serum and heparinized plasma samples are stable 3 to 5 days
if stored at 4°C, 6 months at -20°C.
PRINCIPLE (4) Urines are stable 3 days at room temperature. Do not refrige-
rate urine samples.
Enzymatic determination of uric acid according to the follo-
wing reactions:
Uricase Serum, plasma: Woman Man
Uric acid + 2H2O + O2 Allantoine + CO2 + H2O2
2.6 - 6 3.5 - 7.2 mg/dL
Peroxidase 26 - 60 35 - 72 mg/L
2H2O2 + 4-AAP + EHSPT Quinoneimine + 4H2O 155 - 357 208 - 428 µmol/L
Urine: 250 - 750 mg/24 h
EHSPT = N-Ethyl-N-(2-Hydroxy-3-Sulfopropyl) m-Toluidine 1500 - 4500 µmol/24 h
4-AAP = Amino-4-antipyrine
Note: It is recommended for each laboratory to establish and
REAGENTS COMPOSITION maintain its own reference values. The data given here are only
an indication.
Reagent 1: R1
EHSPT 0.91 mmol/L )PROCEDURE
The reagent can be used on most analysers. The applications
Ascorbate oxidase ≥ 1 000 U/L
Reagent 2: R2
Phosphate buffer, pH 7.00 100 mmol/L Wavelength : 550 nm
4-Aminoantipyrine 1.85 mmol/L Temperature : 37°C
Uricase ≥ 700 U/L Read against reagent blank.
Peroxidase ≥ 7 500 U/L One-reagent procedure
Ferrocyanide 0.14 mmol/L
PRECAUTIONS Working reagent 200 µL 200 µL 200 µL
- The reagents contain less than 0.1 % sodium azide. Sodium Distilled water 5 µL
azide can react with copper and lead plumbing to form explo- Standard 5 µL
sive metal azides. Regulations currently in use regarding dan- Sample 5 µL
the canalisations, rinse with plenty of water. Mix and measure the absorbances (A) after 325 second incu-
- Use clean or single use laboratory equipment only to avoid bation .../...
contaminations.
(01/2005)
FTAN-AUSL-3

URIC ACID SL
• Two-reagent procedure - Correlation

samples. The sample concentrations were up to 25 mg/dL.
The parameters of linear regression are as follows:
Standard 5 µL
Correlation coefficient (r): 0.9992
Sample 5 µL Linear regression: y = 0.983 x + 0.39 mg/dL
Mix, after 75 second incubation read the absorbances (A1) and
add: - Interferences (6)
Reagent R2 50 µL 50 µL 50 µL formed to determine the level of interference from different
compounds:
Mix and measure the absorbances (A2) after 300 second incu-
bation. Bilirubin: No significant interference up to 30 mg/dL
(300 mg/L, 510 µmol/L)
)CALCULATION Haemoglobin: Positive bias from 100 mg/dL (1 g/L) on normal
One-reagent procedure serum and from 300 mg/dL (3 g/L) on pathological serum.
Asample Glucose: No significant interference up to 500 mg/dL (5 g/L,
xn n = standard concentration 28 mmol/L).
Astandard
Ascorbic acid: Negative bias from less than 1.5 mg/dL
• Two-reagent procedure (15 mg/L, 0.083 mmol/L). (Negative bias up to 25% for two-
(A2 - A1)sample reagent procedure or up to 50% for one-reagent procedure)
xn n = standard concentration Turbidity: Positive bias from 250 mg/dL Triglyceride equiva-
(A2 - A1)standard
lent (2.5 g/L, 2.9 mmol/L)
Take the dilution factor into account for the calculation of uric Methyldopa: Negative bias from 1 mg/dL (10 mg/L)
acid concentration in urine.
BIBLIOGRAPHY
CALIBRATION 1.First, M.R., Renal Function. Clinical Chemistry: Theory,
On Cobas Mira, calibration must be performed at least every Analysis, Correlation, 4th Ed., Kaplan, L.A, Pesce, A.J.,
15 days, after each change of batch and according to quality Kazmierczak, S.C., (Mosby Inc. eds St Louis USA), (2003), 477-
appendix.
control results.
2.Newman, D. J., Price, C. P., Non protein Nitrogen Metabolite.
QUALITY CONTROL Tietz Fundamentals of Clinical Chemistry, 5th Ed., Burtis,
To ensure adequate quality, control sera such as ELITROL I C.A. & Ashwood, E.R. (W.B. Saunders eds. Philadelphia USA),
(2001), 414.
mended. 3.Tietz, N.W., Clinical guide to laboratory tests, 3rd Ed, (W.B.
PERFORMANCE DATA 4.Fossati, P., et al., Use of 3,5-dichloro-2-hydroxy-benzenesul-
The following data were obtained using the COBAS MIRA fonic acid/4-aminophenazone chromogenic system in direct
analyser (37°C) enzymatic assay of uric acid in serum and urine. Clin. Chem.,
(1980), 26, 227.
- Analytical range 5.Kaplan, L.A., Pesce, A.J., Examination of Urine. Clinical
The reagent is linear from 1 to 25 mg/dL (10 to 250 mg/L, 60 Chemistry: Theory, Analysis, Correlation, 4th Ed., Kaplan, L.A,
to 1500 µmol/L). Pesce, A.J., Kazmierczak, S.C., (Mosby Inc. eds St Louis USA),
(2003), 1092.
- Detection limit (6) 6.Vassault, A., et al., Protocole de validation de techniques
Determined according to SFBC protocol, the detection limit is (Document B, stade 3). Ann. Biol. Clin., (1986), 44, 686.
equal to 0.5 mg/dL (5 mg/L, 33 µmol/L).
- Sensitivity
The average variation of the analytical signal is 22 × 10-3 ∆A
Lot number
per mg/dL of uric acid (2.2 × 10-3 ∆A per mg/L, 365 ∆A per
µmol/L) for a light path of 1 cm.
- Precision
Medium level: n = 20 m = 4.5 mg/dL CV = 4.7 % Manufacturer’s address
High level: n = 20 m = 11 mg/dL CV = 1.4 %
Expiration date
Medium level: n = 20 m = 4.4 mg/dL CV = 4.1 % Temperature limitation (01/2005)
High level: n = 20 m = 11 mg/dL CV = 1.5 % FTAN-AUSL-3

URIC ACID
Ref : ACUR - 0200 12 x 20 mL

Ref : ACUR - 0400 9 x 50 mL
Ref : ACUR - 0600 6 x 100 mL
For in vitro diagnostic use only Ref : ACUR - 0700 4 x 250 mL
PRINCIPLE PROCEDURE
Enzymatic determination of uric acid according to the follo- Wavelength : 510 nm (492-550)
wing reactions : Temperature : 37°C
Uricase
Uric acid + 2H2O + O2 Allantoine + CO2 + H2O2
Peroxidase
2H2O2 + 4-Aminoantipyrine + DHBS Red quinone BLANK STANDARD SAMPLE
+ H2O + HCl
DHBS = 3,5-Dichloro-2-Hydroxybenzenesulfonic acid
REAGENTS COMPOSITION Standard - 25 µL -

Sample - - 25 µL
Reagent 1 : R1
DHBS 2 mmol/L Mix and read the optical density (OD) after a 5 minute incubation.
Reagent 2 : R2 The final colour is stable for at least 15 minutes.
Peroxidase ≥ 660 U/L CALCULATION
Uricase ≥ 60 U/L mg/dL n= 6
OD Sample
Standard : Std xn mg/L n= 60
OD Standard µmol/L n= 357
Uric Acid 6 mg/dL
60 mg/L n = standard concentration.
357 µmol/L Take the dilution factor into account for the calculation of uric
acid concentration in urine.
PRECAUTIONS
QUALITY CONTROL
HARMFUL ! The standard contains 0.15 % sodium azide.
Harmful if swallowed. After contact with skin , wash immedia-
tely with plenty water. mended.
LINEARITY
are stable until the expiry date stated on the label. Up to 25 mg/dL (250 mg/L) (1487.5 µmol/L).

BIBLIOGRAPHY
OF WORKING REAGENTS
Trivedi R.C., Rebar L., Berka E., Strong L., Clin. Chem., 24,
(1978), 1908.
4 weeks at 2-8°C SYMBOLS USED ON LABELS:
SAMPLES Lot number

Serum.
Heparin plasma. Consult instruction for use
Urine diluted 1/10 in distilled water.
REFERENCE VALUES Manufacturer’s address

Serum, plasma : 3 - 5.7 mg/dL
30 - 57 mg/L Expiration date
178 - 345 µmol/L
Urine : 800 - 1 000 mg/24 h
4 760 - 5 960 µmol/24 h Avoid exposure to direct sunlight
(01/2005)
FTAN-ACUR-2

ZINC
For in vitro diagnostic use only Ref : ZINC - 0100 5 x 10 mL
PRINCIPLE
Zinc, in a pH 8.60 buffer system, forms with specific com- Note : It is recommended for each laboratory to establish and
plexant 5-Br-PAPS a stable coloured complex. The interferen- maintain its own reference values. The data given here are only
ces, due to oligoelements present in the sample, are elimina- an indication.
ted using particular reaction condition and specific masking
agents. PROCEDURE
REAGENTS COMPOSITION most analysers.
Reagent 1 : R1
Wavelength : 560 nm
Buffer, pH 8.60 200 mmol/L
Temperature : 25°C, 30°C, 37°C
Additives Cuvette : 1 cm light path.
Reagent 2 : R2
Complexant 5-Br-PAPS 0.1 mmol/L
Reagent 3 : R3
Reaction enhancer 200 mmol/L WR 2 1 mL 1 mL 1 mL
Standard : Std Distilled water 50 µL - -
Zinc 200 µg/dL Standard - 50 µL -
2 mg/L Sample - - 50 µL
30.6 µmol/L
Mix and read the optical density (∆OD).
STABILITY OF REAGENTS The final colour is stable for at least 1 hour.
are stable until the expiry date stated on the label. CALCULATION
µg/dL n= 200
PREPARATION AND STABILITY OD Sample
xn mg/L n= 2
OF WORKING REAGENTS OD Standard µmol/L n= 30.6
WR1 : Dissolve one level measuring spoonful of reagent 3 in
the reagent 1.
Stability : 30 days at 2-8°C QUALITY CONTROL
WR2 : Mix 10 volumes of WR 1 with 1 volume of the reagent 2. (normal control) and ELITROL II (abnormal control) are recom-
Stability : 10 days at 2-8°C mended.
SAMPLES LINEARITY
Up to 2 000 µg/dL (20 mg/L) (306 µmol/L).
Serum or plasma not hemolyzed ; use only heparin salts as
anticoagulants.
BIBLIOGRAPHY
Urine collected during 24 hours period.
Centrifuged seminal fluid : centrifuge the sample at 3000 1.Homsher R. and Zak, B., Clin. Chem., 31/8, (1985), 1310.
r.p.m. for 10-15 minutes. 2.Makino T. and al., Clinica Chimica Acta, 120, (1982), 127.
Dilute supernatant 1:100 with normal saline.
REFERENCE VALUES Lot Number
Serum, plasma : 68 - 107 µg/dL
0.68 - 1.07 mg/L Consult instruction for use
10.4 - 16.4 µmol/L
Urine : 150 - 1 200 µg/24 h
2.3 - 18.4 µmol/24 h Manufacturer’s address
Centrifuged seminal fluid : 2 - 10 mg/dL Temperature limitation
20 - 100 mg/L (01/2005)
0.3 - 1.5 mmol/L Expiration date FTAN-ZINC-2

<
CONTROLS AND CALIBRATORS
BILICAL
LOT : XXXX
: XXXX
For in vitro diagnostic use only Ref.: BIEN-0055 4 x 5 mL
PRINCIPLE VALUES
BILICAL is a calibrator intended to be used for the quantitative deter- Total Bilirubin: x,x mg/dL
mination of total and direct bilirubin in human serum or plasma, Direct Bilirubin: x,x mg/dL
using Elitech reagents.
DESCRIPTION SYMBOLS USED ON THE LABELS:

- Lyophilized calibrator.
- Bovine albumin matrix containing ditaurobilirubin. Lot Number
PRECAUTIONS Consult instruction for use
- Use only clean or single use glass material to avoid contaminations. In vitro diagnostic medical device
- Discard cloudy calibrator.
PREPARATION Temperature limitation
Carefully open the vial, avoiding the loss of lyophilizate, and pipette
Expiration date
in exactly 5 mL of distilled water.
Carefully close the vial and dissolve the contents completely by occa-
sional gentle swirling within 30 minutes avoiding the formation of
Cal Calibrator
foam.
If not use in a short time, this preparation could be aliquoted and sto-
red at -20°C.
Avoid direct light, which would affect stability of bilirubin.
PROCEDURE
To calibrate with BILICAL follow the procedure described in the ins-
truction for use of the corresponding Elitech reagent.
STABILITY AND STORAGE
Prior to reconstitution, when stored at 2-8° C and protected from

light, Bilical is stable until the expiry date stated on the label.
After reconstitution, the calibrator is stable

2 days at 2-8°C
30 days at -20°C if aliquoted
(11/2004)
FVBL-BIEN-3

CHOLESTEROL LDL
CALIBRATOR
Ref. : LDLD - 0010 4 x 1 mL
LOT XXXXX
For in vitro diagnostic use only XX/XX
PRINCIPLE LIMITATIONS
Cholesterol LDL Calibrator is intended for the calibration of The calibrator has been validated with ELITECH Cholesterol
LDL Cholesterol assays (manual method or automated analy- LDL Direct SL reagent. Users should verify its suitability with
sers) using ELITECH Cholesterol LDL Direct SL reagent. other reagents.
COMPOSITION VALUES
- The Cholesterol LDL calibrator is prepared from human The LDL cholesterol concentration of this lot is:
serum.
- The LDL cholesterol concentration is lot specific. * X.XX g/L
* XXX mg/dL
TRACEABILITY
Concentration value for Cholesterol LDL Calibrator is defined
according to the US CDC LDL-Cholesterol reference method (β-
Quantification method).
PRECAUTIONS
- Respect the normal precautions and good laboratory prac- Lot number
tice. All human material should be considered as potentially
infectious. Consult instruction for use
All products derived from blood are prepared exclusively from
the blood of donors tested individually and found to be nega- In vitro diagnostic medical device
tive for HbsAg and antibodies to HCV and HIV1/HIV2.
However, handle cautiously as potentially infectious. Manufacturer’ s address
- Use only clean or single use glass material to avoid contami-
nations. Expiration date
- Discard cloudy calibrator.
- When stored at 2-8°C and protected from light, the calibra-
tor is stable until the expiry date stated on the label.
- Reconstituted calibrator is stable 7 days at 2-8°C.
- After opening, the vials should be kept correctly and tightly
capped to prevent contamination and evaporation.
PREPARATION
Carefully open the vial, avoiding the loss of lyophilizate, and
pipette in exactly 1 mL of distilled/deionized water.
Carefully close the vial and dissolve the contents completely
by occasionnal gentle swirling avoiding formation of foam.
PROCEDURE
To calibrate with Cholesterol LDL Calibrator follow the proce-
dure described in the instruction for use of the ELITECH
Cholesterol LDL Direct SL reagent.
(11/2004)
FVBL-LDLD-1

CK - MB CONTROL
LOT XXXX
XXXX/XX
Ref : CKMB - 0900 4 x 3 mL

For in vitro diagnostic use only Ref : CKMB - 0003 1 x 3 mL
PRINCIPLE Let the vials remain at room temperature for an additional 20

minutes. Then invert 10 times and gently swirl.
CK-MB Control has been assayed for CK-MB and is intended
to be used as a human serum control product for CK-MB. Use immediately or refrigerate at 2-8° C for future use.
The determination of the content of the CK-MB isoenzyme is a
Reconstituted vials are stable for seven days when stored at 2-
valuable diagnostic tool in the evaluation of many pathological
8° C. If turbid or contamination appears after reconstitution,
conditions. This control is designed for use in both manual
discard immediately.
and automated systems. The use of control material is neces-
sary to systematic test precision in a test system and to detect
systematic analytical deviation that may arise from reagent, or
EXPECTED VALUES
analytical instrument deviation. This control is designed to CK-MB control has been evaluated using ELITECH reagent,
evaluate the patient CK-MB isoenzyme level in the abnormal Ref : CKMB-0030 or CMSL-0410/0430.
conditions. As this freeze-dried isoenzyme is an from human
origin, it can be run side by side with the patient sample ELITECH Reagent CKMB-0030
through all phases of the test method. These human control
eliminates possible altered values found in non-human based XXX (XXX-XXX) U/L
materials. ELITECH Reagent CMSL-0410/0430
PRODUCT DESCRIPTION XXX (XXXX-XXX) U/L
CK-MB isoenzyme control are prepared from human serum
and human derived isoenzyme. This product is freeze-dried for Note : Individual laboratories may not obtain the mean values
extended shelf life. as listed for each lot. Technique, equipment and experimental
error may produce slightly different values. However the values
should fall within the expected range. Each laboratory should
PRECAUTIONS
determine their own mean values for this product.
Check the vial label for the range of isoenzyme values spe- The data given here are only an indication.
cific for the number of control being used.
This product has been found to be non-reactive for Hepatitis B BIBLIOGRAPHY

Surface Antigen (HBsAg) and negative for antibody Human Wong, S.S. Strategic utilisation of cardiac markers for the
Immunodeficiency Virus (HIV), when tested by the FDA appro- diagnosis of acute myocardial infarction. Annals of Clinical
ved third generation methods. and Laboratory Science. 26/4, (1996), 301.
No known methods for HBsAg and HIV can offer total assu-
rance that products derived from human blood will not trans-
mit these diseases. Therefore, human serum products and SYMBOLS USED ON LABELS :
patients samples should be considered potentially hazardous
Lot Number
and handled as if capable of transmitting infectious agents.
Caution, control material contains less than 0.1 % sodium Consult instruction for use
azide. In vitro diagnostic medical device
STABILITY Manufacturer’s address

Prior to reconstitution, when stored at 2-8° C CK-MB isoen- Temperature limitation
zyme control is stable until the expiry date stated on the label.
Expiration date
PREPARATION
Remove vials from refrigerator and allow to warm to room tem-
perature for 15 to 20 minutes.
Remove the seal and rubber stopper from vials.

Volumetrically add exactly 3.0 ± 0.05 mL of distilled or deioni-
zed water using a calibrated pipet. The water used for recons-
titution should be at room temperature, 22-28° C.
Recap the vial and gently swirl 10 times.
Let the vials remain at room temperature for 20 minutes, then

(03/2005)
invert gently 10 times.
FVBL-CKMB-3

ELICAL 2
For in vitro diagnostic use only Ref. : CALI - 0550 4 x 3 mL
PRINCIPLE Stability of total and prostatic acid phosphatase:

ELICAL 2 is a multiparametric calibrator intended for the calibration Between 15- 25°C: 4 hours
of clinical chemistry reagents. Between 2-8° C: 1 day
Between -25 and -15°C: 4 weeks (When frozen once)
DESCRIPTION Note: Store calibrator tightly capped and protected from light when not
ELICAL 2 is a lyophilized calibrator prepared from human serum. The in use.
concentrations and activities of the calibrator components have been
adjusted to en-sure optimal calibration of the clinical chemistry re- PROCEDURE
agents. To calibrate with ELICAL 2 follow the procedure de-scribed in the ins-
tructions for use of the corresponding reagent.
PRECAUTIONS CALIBRATION VALUES

Respect the normal precautions and good laboratory practice. All The concentrations and activities of the components are lot-specific.
human material should be considered as potentially infectious. The exact values are given in the data sheet enclosed in the kit.
All products derived from blood are prepared exclu-sively from the
blood of donors tested individually and found to be negative for HbsAg SYMBOLS USED ON LABEL:
and antibodies to HCV and HIV1/HIV2.
However, handle cautiously as potentially infectious.
Lot Number
PREPARATION Consult instruction for use

Carefully open the vial, avoiding the loss of lyophili-zate, and pipette
in exactly 3 mL of dis-tilled/deionized water. In vitro diagnostic medical device
Carefully close the vial and dissolve the contents com-pletely by occa-
sional gentle swirling within 30 minutes avoiding the formation of Manufacturer’s address
foam.
STABILITY AND STORAGE Expiration date

Prior to reconstitution, when stored at 2-8°C, the reagent is stable
until the expiry date stated on the label.
After reconstitution
Stability of the components:
Between 15- 25°C: 8 hours
Between 2-8° C: 2 days
Exceptions:
Stability of direct bilirubin (when stored protected from light):

Between 2-8° C: 8 hours
Stability of total bilirubin (when stored protected from light):

Between 2-8° C: 1 day
(02/2004)
FTBL-CALI2-2

ELITROL I - ELITROL II
Ref. N° CONT - 0060 10 x 5 mL

For in vitro diagnostic use only Ref. N° CONT - 0160 10 x 5 mL
PRINCIPLE Note:
ELITROL I and II are multiparametric control sera in-tended A light green colour of control sera is without influence on the
for accuracy control of clinical chemistry re-agents. control values.
Store control sera tightly capped after reconstitution.
DESCRIPTION
PROCEDURE
ELITROL I and ELITROL II are lyophilised control sera prepa- Elitrol I and ELITROL II are handled as samples accord-ing to
red from human serum. The concentrations and activities the instructions use of each reagent. It is recom-mended to
have been adjusted to be in the normal range or at the normal use these sera together with samples, at least once a day and
threshold (ELITROL I) or in the patho-logical range (ELITROL after each calibration.
II).
CONTROL VALUES
PRECAUTIONS
The concentrations and activities of the components are lot-
Respect the normal precautions and good laboratory practice. specific. The exact values are given in the data sheet enclosed
All human material should be considered as potentially infec- in the kit.
tious.
All products derived from blood are prepared exclusively from Individual laboratories may not obtain the mean values as
the blood of donors tested individually and found to be nega- listed for each lot. Technique, equipment and experimen-
tive for HbsAg and antibodies to HCV and HIV1/HIV2. tal error may produce slightly diffe-rent values. However
However, handle cautiously as potentially infectious. the values should fall within the expected range. Each
laboratory should deter-mine their own mean values for
this product.
PREPARATION
Carefully open the vial, avoiding the loss of lyophilizate, and SYMBOLS USED ON LABEL:
pipette in exactly 5 mL of distilled/deionized water.
Carefully close the vial and dissolve the contents com-pletely
Lot Number
by occasional gentle swirling within 30 minutes avoiding the
formation of foam. Consult instruction for use
Important : With the exception of alkaline phosphatase, all
enzymes can be measured immediately. To activate the alka- In vitro diagnostic medical device
line phosphatase, incubate the reconstituted control serum for
one hour at 25° C.
Prior to reconstitution, when stored at 2-8°C, the reagent is Expiration date
- Stability of the components:
Between 2-8°C: 5 days
Between -25 and -15°C: 1 month (when frozen once)
Exceptions:
- Stability of total bilirubin (when stored protected from light):
Between 2-8°C: 24 hours
- Stability of direct bilirubin (when stored protected from

light):
Between 2-8°C: 8 hours
Between -25 and -15°C:2 weeks (When frozen once)
(04/2004)
FTAN-CONT-3

CHOLESTEROL
HDL CALIBRATOR
LOT : XXXX
: XXXX
Ref : HDLD - 0025 1 x 3 mL

For in vitro diagnostic use only Ref : HDLD - 0030 4 x 3 mL
PRINCIPLE PREPARATION
The CHOLESTEROL HDL calibrator is designed to be used Bring the calibrator to room temperature before reconstitu-
with HDL Cholesterol Direct test for the quantitative determi- tion.
nation of high density lipoprotein cholesterol (HDL Vial should be opened carefully to avoid loss of freeze-dried
Cholesterol) in serum. powder.
Add exactly 3 mL of distilled water.
PRODUCT DESCRIPTION Mix by gently rotating and allow to stand until dissolution is
complete (20 minutes) . Then mix the content by gently swir-
The CHOLESTEROL HDL calibrator is prepared from human
ling the bottle. Do not shake, to avoid foam formation.
serum.
The control is freeze-dried for extended shelf-life.
Prior to reconstitution, when stored at 2-8 °C and protected
PRECAUTION from light, the HDL Cholesterol is stable until the expiry date
Not to be used internally in humans or animals. stated on the label.
Do not use reagents past the expiration date stated on each
vial label.
The reconstituted calibrator is stable for 7 days at 2-8 °C.
Do not use the reagents for any other purpose than described
herein.
Human serum material was used in the manufacture of this VALUES
product. The raw human serum used was tested and found - The values are based on the US CDC HDL-cholesterol refe-
negative for HBsAg, anti-HIV antibodies and anti HCV antibody. rence method.
Because no test can offer complete assurance that products
derived from human blood will not transmit infectious agents, * XXX mg/dL
it’s recommended that this product should be handled with * XX.X g/L
the same biohazard precautions used for patient specimens.
SYMBOLS USED ON LABEL:
Lot Number
Expiration date
(03/2005)
FVBL-HDLD-4

CHOLESTEROL
S t a n d a r d 200 mg/dL

Réf. : CHOL-0055 4 × 5 mL
PRINCIPLE SYMBOLS USED ON LABEL:

Cholesterol Standard 200 mg/dL is intended for the calibra-
tion of cholesterol assays (manual method or automated ana- Lot N°
lysers) using ELITECH reagents.
COMPOSITION
Standard: Std For in vitro diagnostic
2 g/L
5.17 mmol/L Manufacturer address
Note: The Standard is prepared from bovine cholesterol. Temperature limitation

Therefore, it has a normal yellow colour which has no impact
on the product performances. Expiration date
TRACEABILITY
Concentration value for Cholesterol Standard 200 mg/dL is
traceable to the Standard Reference Material SRM 1951a (of
the National Institute of Standards and Technology).
PRECAUTIONS
nations.
- Discard cloudy reagent.

- When stored at 2-8°C and protected from light, the standard
PREPARATION
The standard is ready for use.
PROCEDURE
To calibrate with Cholesterol Standard 200 mg/dL follow the
procedure described in the instruction for use of the corres-
ponding ELITECH reagent.
LIMITATIONS
The standard has been validated with ELITECH Cholesterol
reagents. Users should verify its suitability with other rea-
gents.
(01/2004)
FTSB-CHOL200-3

CREATININE

Ref. : CREN-0055 4 × 5 mL

Creatinine Standard 2 mg/dL is intended for the calibration of
creatinine (Jaffe and PAP) assays using ELITECH reagents . Lot N°
COMPOSITION Consult instruction for use

Standard : Std
Creatinine 2 mg/dL
20 mg/L For in vitro diagnostic
177 µmol/L
Manufacturer address
TRACEABILITY
Concentration value for Creatinine Standard 2 mg/dL is tra- Temperature limitation
ceable to the Standard Reference Material SRM 914 (of the
National Institute of Standards and Technology). Expiration date
PRECAUTIONS
nations.

PREPARATION
PROCEDURE
To calibrate with Creatinine Standard 2 mg/dL follow the pro-
cedure described in the instruction for use of the correspon-
ding ELITECH reagent.
LIMITATIONS
The standard has been validated with ELITECH Creatinine
gents.
(01/2005)
FTSB-CREN2-2

GLUCOSE

Ref. : GLUP-0055 4 × 5 mL

Glucose Standard 100 mg/dL is intended for the calibration of
glucose assays (manual method or automated analysers) using Lot N°
ELITECH reagents.
COMPOSITION
Standard: Std For in vitro diagnostic
D-Glucose 100 mg/dL
1 g/L
5.56 mmol/L Manufacturer address
TRACEABILITY Temperature limitation

Concentration value of Glucose Standard 100 mg/dL is tra-
ceable to the Standard Reference Material SRM 917 (of the Expiration date
National Institute of Standards and Technology).
PRECAUTIONS
nations.

PREPARATION
PROCEDURE
To calibrate with Glucose Standard 100 mg/dL follow the pro-
cedure described in the instruction for use of the correspon-
ding ELITECH reagent.
LIMITATIONS
The standard has been validated with ELITECH Glucose rea-
gents. Users should verify its suitability with others glucose
methods.
(01/2004)
FTSB-GLUP100-1

MICROPROTEIN

Réf. : PRTP-0020 4 × 2 mL
PRINCIPE SYMBOLS USED ON LABEL:

Microprotein Standard 20 mg/dL est un standard destiné à la
calibration du dosage des microprotéines effectué à l'aide des Lot N°
réactifs ELITECH (méthodes d'analyses manuelles ou automa-
tisées). Consult instruction for use
COMPOSITION For in vitro diagnostic

Standard : Std
Albumine/globuline 200 mg/L
20 mg/dL Manufacturer address
TRAÇABILITE Temperature limitation

La valeur du Standard Microprotein 20 mg/dL est définie par
rapport au matériau de référence SRM 927 (du National Expiration date
Institute of Standards and Technology).
PRECAUTIONS
- Utiliser une verrerie propre ou à usage unique afin d'éviter
toute contamination.
- Rejeter tout standard présentant un trouble.
STABILITE ET CONSERVATION
- Le standard conservé à 2-8°C et à l'abri de la lumière est sta-
ble jusqu'à la date de péremption figurant sur l'étiquette.
- Après utilisation, le flacon doit immédiatement et correcte-
ment être refermé afin d'éviter toute contamination ou évapo-
ration.
PREPARATION
Le standard est prêt à l'emploi.
MODE OPERATOIRE
Pour calibrer avec le Standard Microprotein 20 mg/dL suivre
les instructions de la fiche technique du réactif ELITECH ser-
vant au dosage.
LIMITATIONS
Ce standard a été validé avec les réactifs Microprotein ELI-
TECH. Les utilisateurs doivent s'assurer qu'il peut être utilisé
avec les autres méthodes de quantification des microprotéines.
(07/2004)
FTSB-PRTP20-1

MICROPROTEIN

Ref. : PRTP-0022 4 × 2 mL

Microprotein Standard 100 mg/dL is intended for the calibra-
tion of microprotein assays using ELITECH reagents (manual Lot N°
method or automated analysers).
COMPOSITION
Standard : Std
Albumin/globulin 1000 mg/L For in vitro diagnostic
100 mg/dL
TRACEABILITY
Concentration value for Microprotein Standard 100 mg/dL is Temperature limitation
traceable to the Standard Reference Material SRM 927 (of the
National Institute of Standards and Technology). Expiration date
PRECAUTIONS
nations.

PREPARATION
PROCEDURE
To calibrate with Microprotein Standard 100 mg/dL follow the
LIMITATIONS
The standard has been validated with ELITECH Microprotein
gents.
(07/2004)
FTSB-PRTP100-1

TRIGLYCERIDES

Ref. : TRIG-0055 4 × 5 mL

Triglycerides Standard is intended for the calibration of trigly-
cerides assays (manual method or automated analysers) using Lot N°
ELITECH reagents.
COMPOSITION
Standard: Std
For in vitro diagnostic
Glycerol 200 mg/dL
(triglycerides equivalent)
2 g/L Manufacturer address
2.28 mmol/L
TRACEABILITY
Concentration value for Triglycerides Standard 200 mg/dL is Expiration date
traceable to the Standard Reference Material SRM 1951a (of
the National Institute of Standards and Technology).
PRECAUTIONS
- Triglycerides Standard contains less than 0.1% of sodium
azide. Sodium azide may react with lead and copper plumbing
to form explosive metal azides. Regulations currently in use
regarding the dangerous waste elimination must be respected.
If discharge in the canalisations, rinse with plenty of water.
nations.

PREPARATION
PROCEDURE
To calibrate with Triglycerides Standard 200 mg/dL follow the
LIMITATIONS
The standard has been validated with ELITECH Triglycerides
gents.
(01/2004)
FTSB-TRIG200-1

UREA

Ref. : URUV-0055 4 × 5 mL

Urea Standard 50 mg/dL is intended for the calibration of
urea assays (manual method or automated analysers) using Lot N°
ELITECH reagents.
COMPOSITION
Standard: Std
For in vitro diagnostic
Urea 50 mg/dL
0.5 g/L
8.32 mmol/L
TRACEABILITY Temperature limitation

Concentration value for Urea Standard 50 mg/dL is traceable
to the Standard Reference Material SRM 909b (of the National Expiration date
Institute of Standards and Technology).
PRECAUTIONS
nations.

PREPARATION
PROCEDURE
To calibrate with Urea Standard 50 mg/dL follow the proce-
dure described in the instruction for use of the corresponding
ELITECH reagent.
LIMITATIONS
The standard has been validated with ELITECH Urea reagents.
Users should verify its suitability with others urea methods.
(01/2004)
FTSB-URUV50-1

URIC ACID

Ref : ACUR-0055 4 × 5 mL

Uric Acid Standard 6 mg/dL is intended for the calibra-tion of
uric acid assays (manual method or automated analysers) Lot N°
using ELITECH reagents.
COMPOSITION
Standard: Std
Uric Acid 6 mg/dL For in vitro diagnostic
60 mg/L
357 µmol/L Manufacturer address
Note: Uric Acid Standard contains bovine albumin. Temperature limitation
TRACEABILITY Expiration date

Concentration value of Uric Acid Standard 6 mg/dL is tracea-
ble to a reference method, the ID-MS (Isotope dilution-Mass Avoid exposure to direct sunlight
Spectrometry).
PRECAUTIONS
-HARMFUL !
Uric Acid Standard contains 0.15% of sodium azide. Sodium
azide may react with lead and copper plumbing to form explo-
sive metal azides. Regulations current in use regarding the
dangerous waste elimination must be respected. If discharge
in the canalisations, rinse with plenty of water.
R21: Harmful in contact with skin.
R22: Harmful if swallowed.
S26: In case of contact with eyes, rinse immediately with
plenty of water and seek medical advice.
S28: In case of contact with skin, rinse immediately with
plenty of water.
S45: In case of accident, or if you feel unwell, seek im-media-
tely medical advice (show the label where possi-ble).
nations.

capped to prevent contamination and evapora-tion.
PREPARATION
(01/2004)
FTSB-ACUR6-1

IMMUNOLOGY
AGGLUTINATION REAGENTS
ASO LATEX
For in vitro diagnostic use only Réf. : LXAS - 0115 100 Tests
)CLINICAL SIGNIFICANCE SAMPLES

-Specimen:
Streptolysin O is a toxic immunogenic exoenzyme produced by
Fresh serum
β-haemolitic Streptococci of groups A, C and G. Measuring the
Do not use highly hemolysed or lipemic samples.
ASO antibodies are useful for the diagnostic of rheumatoid
Samples with presence of fibrin should be centrifuged before
fever, acute glomerulonephritis and streptococcal infections.
testing.
Rheumatic fever is an inflammatory disease affecting connec-
-Storage
tive tissue from several parts of human body as skin, heart,
Stable 7 days at 2-8°C or 3 months at - 20°C.
joints, etc… and acute glomerulonephritis is a renal infection
that affects mainly to renal glommerulus. QUALITATIVE TEST
METHOD Procedure
Qualitative or semi-quantitative 1.Allow the reagents and samples to reach room temperature.
Direct agglutination on latex particles. The sensitivity of the test may be reduced at low temperature.
2.Place 50 µL of the sample and one drop (50 µL) of each posi-
PRINCIPLE tive and negative controls into separate circles on the slide
test.
The ASO Latex is a slide agglutination test for the qualitative
3.Swirl the ASO latex reagent gently before using and add one
and semi-quantitative detection of anti-streptolysin O (ASO) in
drop ( 50 µL) next to the samples to be tested.
human serum.
4.Mix the drops with stirrer, spreading them over the entire
Latex particles coated with streptolysin O are agglutinated
surface on the circle.
when mixed with samples containing ASO.
5.Rotate the slide manually or a mechanical rotator for 2
minutes.
REAGENTS COMPOSITION AND MATERIEL PROVIDED 6.Examine macroscopically the presence or absence of visible
Réactif R 2 x 2.5 ml agglutination immediately after removing the slide from the
Latex particles coated with streptolysin O rotator.
Contrôle positif C + 1 x 1 ml Reading and interpretation

Human serum with ASO concentration > 200 IU/mL Positive: the presence of agglutinations indicates content of
ASO in the sample equal or greater than 200 IU/mL.
Contrôle négatif C - 1 x 1 ml Negative: The lack of agglutination indicates an ASO level
Animal serum lower than 200 IU/mL in the sample, within the normal range.
Plastic stirrers 100
Note : Delay on reading the results may result in over-suresti-
Glass slide 1
mation of the ASO level.
)PRECAUTIONS
-The reagent and controls contain 0.095 % sodium azide. SEMI-QUANTITATIVE TEST
Sodium azide can react with copper and lead plumbing to form Procedure :
explosive metal azides.
Regulations currently in use regarding dangerous waste elimi- 1.Make serial two fold dilutions of the sample ( found pre-
nation must be respected. If discharge in the canalisations, viously positive) in the saline solution (NaCl 0.9 %).
rinse with plenty water. 2.Proceed for each dilution as in qualitative method.
-Components from human origin have been tested and found
to be negative for the presence of HBsAg, HCV, and antibody Reading and interpretation
to HIV(1/2). However handle cautiously as potentially infec- The titer is defined as the highest dilution showing the posi-
tious. tive result.
-Use clean or single use laboratory equipment only to avoid The approximate ASO concentration in the patient sample is
contaminations. calculated as follow :
200 x ASO Titer = IU/mL
.../...
When stored at 2-8°C and protected from light , the reagent
and controls are stable until the expiry date stated on the
label.
Do not freeze. (03/2005)
FTAN-LXAS-4

ASO LATEX
The ASO detection limit is calibrated to the International stan- 1. Haffejee . Quarterly Journal of Medicine 1992. New series
dard WHO. 84; 305: 641
2. Ahmed Samir et al. Pediatric Annals 1992; 21: 835
)QUALITY CONTROL 3. J Spaun et al. Bull Wld Hlth Org 1961; 24: 271.
Positive and negative controls are recommended to monitor 4. The association of Clinical Pathologists 1961. Broadsheet
the performance of the procedure, as well as a comparative 34
pattern for a better result interpretation 5. B Picard et al. La Presse Medicale 1983; 23: 2
)REFERENCE VALUES 6. Luis Borque et al. Journal of Clinical Immunoassay. 1992;
15(3): 182.
Adults : <_ 200 IU/mL 7. Young DS. Effects of Drugs on clinical laboratory test, 4th
Children ( < 5 years old ) : <_ 100 IU/mL ed; AACC Press, 1995.
Note : It is recommended for each laboratory to establish and SYMBOLS USED ON THE LABELS:
maintain its own reference values. The data given here only an
indication. Lot number
)PERFORMANCE DATA Consult instruction for use
-Detection limit: In vitro diagnostic medical device

The detection limit is 200 (+/− 50) IU/mL .
-Hook effect :
No prozone effect was detected up to 1500 IU/mL Temperature limitation
-Clinical study : Expiration date
From 120 patients tested (50 positive and 70 negative sera),

the results are :
- Sensitivity : 98 %
- Specificity : 97 %
-Interferences
Some studies have been performed to determine the level of
inter-ference from different compounds :
Bilirubin : No significant interference up to 20 mg/dL (200

mg/L).
Haemoglobin : No significant interference up to 100 mg/dL (10
g/L)
Lipids : No significant interference up to 100 mg/dL (10 mg/L).
Rhumatoid factors : No significant interference up to 300
IU/mL .
Others compounds may interfere.7
LIMITATION
1.False positive results may be obtained in conditions such as,
rheumatoide arthritis, scarlet fever, tonsilitis, several strepto-
coccal infections and healthy carriers.
2. Early infections and children from 6 months to 2 years may
cause false negative results.
3.A single ASO determination does not produce much
informa-tion about the actual state of the disease. Titrations at
biweekly intervals during 4 or 6 weeks are advisable to follow
the disease evolution.
4.Clinical diagnosis should not be made on findings of a sin-
gle test result, but should integrate both clinical and labora- (03/2005)
tory data. FTAN-LXAS-4

CRP LATEX
For in vitro diagnostic use only Réf. : LXCR - 0115 100 Tests
CLINICAL SIGNIFICANCE SAMPLES

- Specimen:
CRP is an acute-phase protein present in normal serum,
Fresh serum
which increases significantly after most forms of tissue inju-
Do not use highly hemolysed or lipemic samples.
ries, bacterial and virus infections, inflammation and mali-
Samples with presence of fibrin should be centrifuged before
gnant neoplasia.
testing.
During tissue necrosis and inflammation resulting from micro-
- Storage
bial infections, the CRP concentration can rise by more than
300 mg/L in 12-24 hours.
QUALITATIVE TEST
METHOD
Procedure
Qualitative or semi-quantitative
1.Allow the reagents and samples to reach room temperature.
Direct agglutination on latex particles.
The sensitivity of the test may be reduced at low temperature.
PRINCIPLE 2.Place 50 µL of the sample and one drop (50 µL) of each posi-
tive and negative controls into separate circles on the slide test.
The CRP Latex is a slide agglutination test for the qualitative 3.Swirl the CRP latex reagent gently before using and add one
and semi-quantitative detection of C-Reactive Protein (CRP) in drop ( 50 µL) next to the samples to be tested.
human serum. 4.Mix the drops with stirrer, spreading them over the entire
Latex particles coated with goat IgG anti-human CRP are surface on the circle.
agglutinated when mixed with samples containing CRP. 5.Rotate the slide manually or a mechanical rotator for 2 minu-
tes.
)REAGENTS COMPOSITION AND MATERIEL PROVIDED 6.Examine macroscopically the presence or absence of visible
agglutination immediately after removing the slide from the
Reagent R 2 x 2.5 mL rotator.
Latex particles coated with goat IgG anti-human CRP
Reading and interpretation
Positive control C + 1x 1 ml
Positive: the presence of agglutinations indicates content of
Human serum with CRP concentration > 20 mg/L
CRP in the sample equal or greater than 6 mg/L.
Negative control C - 1x 1 ml Negative: The lack of agglutination indicates a CRP level lower
Animal serum than 6 mg/L in the sample, within the normal range.
Plastic stirrers 100 Note : Delay on reading the results may result in over-surestima-
Glass slide 1 tion of the CRP level.
PRECAUTIONS SEMI-QUANTITATIVE TEST
-The reagent and controls contain 0.095 % sodium azide. Procedure :
Sodium azide can react with copper and lead plumbing to form
explosive metal azides. 1.Make serial two fold dilutions of the sample ( found pre-
Regulations currently in use regarding dangerous waste elimi- viously positive) in the saline solution (NaCl 0.9 %)
nation must be respected. If discharge in the canalisations, 2.Proceed for each dilution as in qualitative method.
rinse with plenty water.
The titer, is defined as the highest dilution showing the positive
to be negative for the presence of HBsAg, HCV, and antibody
result.
to HIV(1/2). However handle cautiously as potentially infec-
The approximate CRP concentration in the patient sample is
tious.
calculated as follow :
-Use clean or single use laboratory equipment only to avoid
6 x CRP Titer = mg/L
contaminations.
STABILITY OF REAGENTS …/…
When stored at 2-8°C and protected from light , the reagent

label.
Do not freeze.
(03/2005)
FTAN-LXCR-4

CRP LATEX
The CRP detection limit is calibrated to the Reference Material
CRM 470/RPPHS. 1. Lars-Olof Hanson et al. Current Opinion in Infectious disea-
ses 1997; 10: 196
2. M.M. Pepys. The Lancet 1981; March 21: 653
)QUALITY CONTROL
3. Chetana Vaishnavi. Immunology and Infectious Diseases
Positive and negative controls are recommended to monitor
1996; 6: 139
the performance of the procedure, as well as a comparative
4. Yoshitsugy Hokama et al. Journal of Clinical Laboratory
pattern for a better result interpretation
Status 1987; 1: 15
5. S. Yamamoto et al. Veterinary Immunology and
)REFERENCE VALUES Immunopathology 1993; 36: 257
Serum : <_ 6 mg/L 6. Charles Wadsworth et al. Clinica Chimica Acta; 1984: 138:
309.
Note : It is recommended for each laboratory to establish and 7. Young DS. Effects of Drugs on clinical laboratory test, 4th
maintain its own reference values. The data given here only an ed; AACC Press, 1995.
indication.
SYMBOLS USED ON THE LABELS:
PERFORMANCE DATA
Lot number
-Detection limit
The detection limit is 6 (5-10) mg/L Consult instruction for use
-Hook effect In vitro diagnostic medical device

No prozone effect was detected up to 1600 mg/L
-Clinical study :
From 125 patients tested (47 positive and 78 negative sera),
the results are : Expiration date
- Sensitivity : 95.6 %
- Specificity : 96.2 %
- Interferences
interference from different compounds :

mg/L).
g/L)
Rhumatoid factors : An interference from to 100 IU/mL .
LIMITATION
1. High CRP concentration samples may give negative results
(Prozone effect). In this case, re-test the sample again using a
drop of 20 µL of sample.
2. The strength of agglutination is not indicative of the CRP
concentration in the samples tested.
3. Clinical diagnosis should not be made on findings of a sin-
gle test result, but should integrate both clinical and labora-
tory data.
(03/2005)
FTAN-LXCR-4

FR LATEX
For in vitro diagnostic use only Réf. : LXRF- 0115 100 Tests
CLINICAL SIGNIFICANCE )SAMPLES

Rheumatoid factors (RF) are a group of antibodies directed to - Specimen:
determinants in the Fc portion of the immunoglobulin G mole- Fresh serum
cule primarily found in the serums of patients reached of Do not use highly hemolysed or lipemic samples.
rheumatoid polyarthrite. The specificity of these factors is very Samples with presence of fibrin should be centrifuged before
variable. They can react with animal immnunoglobins (like testing.
this one of rabbit in Waaler rose reaction) and human homo- - Storage
log immunoglobins (like latex test). Stable 7 days at 2-8°C or 3 months at - 20°C.
However, the presence of these factors is not specific of this
pathology, they are found in healthy subjects, in syndromes QUALITATIVE TEST
such systemic lupus erythematosus (SLE) and Sjögren's syn-
Procedure
drome and of many bacteria and viral affections (tuberculosis,
1.Allow the reagents and samples to reach room temperature.
leprosy, syphilis, hepatitis, etc…)
The sensitivity of the test may be reduced at low temperature.
METHOD 2.Place 50 µL of the sample and one drop (50 µL) of each posi-
Qualitative or semi-quantitative tive and negative controls into separate circles on the slide test.
Direct agglutination on latex particles. 3.Swirl the Waaler rose reagent gently before using and add one
drop ( 50 µL) next to the samples to be tested.
PRINCIPLE 4.Mix the drops with stirrer, spreading them over the entire
The FR Latex is a slide agglutination test for the qualitative 5.Rotate the slide manually or a mechanical rotator for 2 minu-
and semi-quantitative detection of RF in human serum. tes.
Latex particles coated with human IgG are agglutinated when 6.Examine macroscopically the presence or absence of visible
mixed with samples containing RF. agglutination immediately after removing the slide from the
rotator.
)REAGENTS COMPOSITION AND MATERIEL PROVIDED
Reagent R 2 x 2.5 mL
Positive: the presence of agglutinations indicates content of RF
Latex particles coated with human IgG
in the sample equal or greater than 8 IU/mL.
Positive control C + 1x 1 ml Negative: The lack of agglutination indicates a RF level lower
Human serum with RF concentration > 30 IU/mL than 8 IU/mL in the sample, within the normal range.
Negative control C - 1x 1 ml
Note : Delay on reading the results may result in over-surestima-
Animal serum
tion of the RF level.
Glass slide 1 SEMI-QUANTITATIVE TEST
Procedure :
PRECAUTIONS
1.Make serial two fold dilutions of the sample ( found pre-
-The reagent and controls contain 0.095 % sodium azide.
viously positive) in the saline solution (NaCl 0.9 %).
2.Proceed for each dilution as in qualitative method.
Regulations currently in use regarding dangerous waste elimi- Reading and interpretation
nation must be respected. If discharge in the canalisations, The titer, is defined as the highest dilution showing the positive
rinse with plenty water. result.
-Components from human origin have been tested and found The approximate RF concentration in the patient sample is cal-
to be negative for the presence of HBsAg, HCV, and antibody culated as follow :
to HIV(1/2). However handle cautiously as potentially infec- 8 x RF Titer = IU/mL
tious.
-Use clean or single use laboratory equipment only to avoid …/…
contaminations.
When stored at 2-8°C and protected from light, the reagent
(03/2005)
label.
FTAN-LXRF-4
Do not freeze.

FR LATEX
)CALIBRATION BIBLIOGRAPHY
The FR latex detection limit is calibrated to the International
1. Robert W Dorner et al. Clinica Chimica Acta 1987; 167: 1.
RF reference WHO 64/2 Rheumatoid Arthritis Serum.
2. Frederick Wolfe et al. Arthritis and Rheumatism 1991; 34:
951.
)QUALITY CONTROL 3. Robert H Shmerling et al. The American Journal of Medicine
1991; 91: 528.
4. Adalbert F. Schubart et al. The New England Journal of
Medicine 1959; 261: 363.
REFERENCE VALUES 5. Charles M. Plotz 1956; American Journal of Medicine;
21:893.
Serum : <_ 8 IU/mL 6. Young DS. Effects of drugs on clinical laboratory test, 4th
ed. AACC Press, 1995.
indication. SYMBOLS USED ON THE LABELS :
)PERFORMANCE DATA Lot number

-Detection limit Consult instruction for use
The detection limit is 8 (6-16) IU/mL
-Threshold of positivity
The threshold is 20 IU/mL Manufacturer’ s address
-Hook effect Temperature limitation
No prozone effect was detected up to 800 IU/mL
Expiration date
-Clinical study :
From118 patients tested (50 positive and 68 negative sera), the
results are :
- Interferences

mg/L).
g/L)
LIMITATION
1-The incidence of false positive results is about 3-5 %.
Individuals suffering from infectious mononucleosis, hepatitis,
syphilis as well as elderly people may give positive results.
2-Diagnosis should not be solely based on the results of
Waaler Rose method but also should be complemented with a
RF-Latex test along with the clinical examination.
3-Results obtained with a Waaler Rose method do not compare
with those obtained with RF- Latex method. Differences in the
results between methods do not reflect
(03/2005)
FTAN-LXRF-4

RPR CARBON
For in vitro diagnostic use only Réf. : LXRP-0155 150 Tests
)CLINICAL SIGNIFICANCE )SAMPLES

Reagins are a group of antibodies against some components of - Specimen:
the damage tissues from patients infected by Treponema pal- Fresh serum
lidum, the agent which causes the syphilis .This microorga- Do not use highly hemolysed or lipemic samples.
nism produces some damage to the liver and heart, releasing Samples with presence of fibrin should be centrifuged before
some tissue fragments. Immunological patient system reacts testing.
producing reagins, antibodies against these fragments. - Storage
METHOD
Qualitative or semi-quantitative
Agglutination reaction QUALITATIVE TEST
Procedure :
PRINCIPE
The RPR-carbon is a non-treponemal slide agglutination test 1.Allow the reagents and samples to reach room temperature.
for the qualitative and semi-quantitative detection of plasma The sensitivity of the test may be reduced at low temperature.
reagins in human serum. Carbon particles coated with a lipid 2.Place 50 µL of the sample and one drop (50 µL) of each posi-
complex are agglutinated when mixed with samples containing tive and negative controls into separate circles on the slide test.
reagins. 3.Swirl the reagent gently before using and add one drop
(20 µL) with dispensing bottle and the needle or a pipet next to
)REAGENTS COMPOSITION AND MATERIEL PROVIDED the samples to be tested.
4.Mix the drops with stirrer, spreading them over the entire sur-
Reagent R 1 x 3 ml
face on the circle.
Carbon particles coated with a lipid complex, cardiolipin, leci-
5.Rotate the slide manually or a mechanical rotator for 8 minu-
thin and cholesterol in phosphate buffer 20 mmol/L.
tes.
Positive control C + 1x 1 ml
6.Examine macroscopically the presence or absence of visible
Human serum
Negative control C - 1 x 1 ml
rotator.
Animal serum
Glass slide 18 Positive result : Marked aggregation in the center or around
Dispensing bottle and needle the edge of the deposit.
Uncertain result : Small aggregates around the edges of the
PRECAUTIONS deposit.
-The reagent and controls contain 0.095 % sodium azide. Negative result : Homogeneous mixture with no visible aggre-
Sodium azide can react with copper and lead plumbing to form gates.
Regulations currently in use regarding dangerous waste elimi- Note : Delay on reading the results may result in over-surestima-
nation must be respected. If discharge in the canalisations, tion of the antibodies level.
-Components from human origin have been tested and found SEMI-QUANTITATIVE TEST
Procedure :
Positive sera may be tittered in making serial dilution in phy-
tious.
siological serum ( NaCl 0.9 %) (1/2, 1/4, 1/8, 1/16, 1/32).
The test will be performed in the same way than qualitative test.
contaminations.
STABILITY OF REAGENTS The serum titre will be interpreted as the highest dilution giving
When stored at 2-8°C and protected from light , the reagent visible aggregation. If the highest dilution produces aggregation,
and controls are stable until the expiry date stated on the titration will continue on higher dilutions (1/64,1/128,1/512..)
label.
Do not freeze. …/…
(03/2005)
FTAN-LXRP-4

RPR CARBON
The reagent sensitivity is calibrated against the "Human 1. Georges P.Schmid .Current Opinion in Infectious Diseases
Reactive Serum" from CDC (Centre for Disease Center). 1994; 7:34-40.
2. Sandra A. Larsen et al. Clinical Microbiology Reviews 1995
; 8 (1)-21.
)QUALITY CONTROL
3. Sandra A. Larsen et al. A manual of Test for Syphilis
American Public Health Association 1990 : 1-192.
4. Marry W. Perryman et al. Journal of Clinical Microbiology.
1982; 16: 286-290.
5. Young DS. Effects of Drugs on clinical laboratory test, 4th
)PERFORMANCE DATA ed; AACC Press, 1995.
-Detection limit
The detection limit has been defined for the dilution at 1/16. SYMBOLS USED ON THE LABELS :
-Hook effect Lot number

No prozone effect was detected up to titers ≥ 1/128.
-Clinical study :
From 77 patients tested (28 positive and 49 negative sera), the
results are : Manufacturer’ s address
- Sensitivity : 100 % Temperature limitation

Expiration date
- Interferences

mg/L).
g/L)
Rhumatoid factors : No significant interference up to 300
IU/mL.
LIMITATION
1-As with tests based on reagins determination, the RPR
syphilis test may produce false positive results. These can be
linked to diseases such leprosy, systemic lupus erythemato-
sus (SLE) infectious mononucleosis, maleria, viral pneumonia.
Any positive result must be confirmed by another serological
assay (e.g TPHA).
Final diagnosis will only be reached after correlation of the
results with clinical signs.
2-Contaminated sera and excessive reaction times may cause
false positive results.
3-At the end of each daily use, remove the needle from the
antigen bottle, rinse it carefully with distilled water and air-
day it. The antigen suspension kept in the dispensing bottle
may lose some of its stability in the long term, therefore it is
recommended to pour it back in its original container at the
end of the procedure. Carefully rinse bottle and needle with
distilled water, then air dry them.
(03/2005)
FTAN-LXRP-4

WAALER ROSE
For in vitro diagnostic use only Ref.: LXWR - 0115 100 Tests
CLINICAL SIGNIFICANCE )SAMPLES

Rheumatoid factors are a group of antibodies directed to deter- - Specimen:
minants in the Fc portion of the immunoglobulin G molecule Fresh serum
primarily found in the serums of patients reached of rheuma- Do not use highly hemolysed or lipemic samples.
toid polyarthrite. The specificity of these factors is very varia- Samples with presence of fibrin should be centrifuged before
ble. They can react with animal immnunoglobins (like this one testing.
- Storage
of rabbit in Waaler rose reaction) and human homolog immu-
noglobins (like latex test).
However, the presence of these factors is not specific of this
QUALITATIVE TEST
pathology, they are found in healthy subjects, in syndromes
such systemic lupus erythematosus (SLE) and Sjögren's syn- Procedure
drome and of many bacteria and viral affections (tuberculosis, 1.Allow the reagents and samples to reach room temperature.
leprosy, syphilis, hepatitis, etc…) The sensitivity of the test may be reduced at low temperature.
2.Place 50 µL of the sample and one drop (50 µL) of each posi-
METHOD tive and negative controls into separate circles on the slide
Qualitative or semi-quantitative test.
Haemaagglutination reaction. 3.Swirl the Waaler rose reagent gently before using and add
one drop ( 50 µL) next to the samples to be tested.
PRINCIPLE 4.Mix the drops with stirrer, spreading them over the entire
The Waaler Rose test is a slide haemagglutination method for
the qualitative and semi-quantitative detection of RF in 5.Let the slide undisturbed on a flat surface for 2 minutes.
human serum. Stabilized sheep erythrocytes sensitized with 6.Rotate the slide manually or a mechanical rotator for 1
rabbit IgG anti-sheep erythrocyte are agglutinated when mixed minute.
with samples containing RF. 7.Examine macroscopically the presence or absence of visible
)REAGENTS COMPOSITION AND MATERIEL PROVIDED rotator.
Reagent R 2 x 2.5 ml
Stabilized sheep erythrocytes sensitized with rabbit IgG anti-
sheep erythrocyte Positive: the presence of agglutinations indicates content of
Positive control C+ 1 x 1 ml RF in the sample equal or greater than 8 IU/mL.
Human serum with RF concentration > 30 IU/mL Negative: The lack of agglutination indicates a RF level lower
Negative control C- 1 x 1 ml than 8 IU/mL in the sample, within the normal range.
Animal serum.
SEMI-QUANTITATIVE TEST
Glass slide 17 Procedure :
1.Make serial two fold dilutions of the sample (found pre-
PRECAUTIONS viously positive) in the saline solution (NaCl 0.9 %)
2.Proceed for each dilution as in qualitative method.
-The reagent and controls contain 0.095 % sodium azide.
The titer, is defined as the highest dilution showing the posi-
tive result.
The approximate RF concentration in the patient sample is
calculated as follow :
8 x RF Titer = IU/mL
tious.
contaminations.
STORAGE AND STABILITY .../...

When stored at 2-8 °C and protected from light, the reagent and
controls are stable until the expiry date stated on the label.
Do not freeze.
(03/2005)
FTAN-LXWR-4

WAALER ROSE
The Waaler rose detection limit is calibrated to the
1. Robert W Dorner et al. Clinica Chimica Acta 1987; 167: 1.
International RF reference WHO 64/2 Rheumatoid Arthritis
2. Frederick Wolfe et al. Arthritis and Rheumatism 1991; 34:
Serum.
951.
3. Robert H Shmerling et al. The American Journal of
)QUALITY CONTROL Medicine 1991; 91: 528.
Positive and negative controls are recommended to monitor 4. Koritz T N et al. Journal of Inmmunological Methods.
the performance of the procedure, as well as a comparative 1980; 32; 1.
pattern for a better result interpretation 5. Assameh S N et al. Journal of Immunological Methods
1980; 34: 205.
REFERENCE VALUES 6. Young DS. Effects of drugs on clinical laboratory test, 4th
ed. AACC Press, 1995
Serum : <_ 8 UI/mL
Note : It is recommended for each laboratory to establish and SYMBOLS USED ON LABELS :
indication. Lot number

)PERFORMANCE DATA
-Detection limit In vitro diagnostic medical device
The detection limit is 8 (6-16) IU/mL
-Hook effect
Expiration date
No prozone effect was detected up to 800 IU/mL
-Clinical study :
From 84 patients tested (40 positive and 44 negative sera), the

results are :
- Specificity : 93.6 %
- Interferences

mg/L).
g/L)
LIMITATION
1-The incidence of false positive results is about 3-5 %.
Individuals suffering from infectious mononucleosis, hepatitis,
syphilis as well as elderly people may give positive results.
2-Diagnosis should not be solely based on the results of
Waaler Rose method but also should be complemented with a
RF-Latex test along with the clinical examination.
3-Results obtained with a Waaler Rose method do not compare
with those obtained with RF- Latex method. Differences in the
results between methods do not reflect differences in the abi-
lity to detect rheumatoid factors.
(03/2005)
FTAN-LXWR-4

RAPID TESTS
PREGTEST II
Ref : RTHC - 3110 Unit test

For in vitro diagnostic use only Ref : RTHC - 0030 30 tests
CLINICAL SIGNIFICANCE SPECIMEN COLLECTION

Human chorionic gonadotropin (hCG) is a glycoprotein hor- Urine : the urine specimen must be collected in a clean and
mone produced by the developing placenta shortly after fertili- dry plastic or glass container without any preservatives. The
zation. The appearance of hCG in both the urine and serum first morning urine is preferred since it generally contains the
soon after conception, and its subsequent rapid rise in highest concentration of hCG. However, urine collected at any
concentration during early gestational growth, make it an time of day may be used. Urine samples exhibiting visible pre-
excellent marker for the early detection of pregnancy. cipitates should be centrifuged, filtered, or allowed to settle to
obtain clear supernatant for testing. Urine containing exces-
METHOD sive bacterial contamination should not be used, as may cause
Qualitative spurious results.
Immunochromatography. Serum : remove the serum from clot as soon as possible to
avoid hemolysis. Use clear non-hemolyzed specimens when
PRINCIPLE possible. Specimens containing particulate matter should be
clarified by centrifugation prior to assay.
PREGTEST II is a rapid chromatographic immunoassay for the
Specimen Storage: Urine or serum specimens may be stored
qualitative detection of human chorionic gonadotropin (hCG)
at 2-8 °C for up to 48 hours prior to assay. For prolonged sto-
in urine or serum, as an aid for the early detection of pre-
rage, specimens may be frozen and stored below -20° C up to
gnancy.
5 days.
The membrane is pre-coated with mouse anti-hCG antibodies
on the test line region (T) and goat anti-mouse antibodies on TEST PROCEDURE
the control line region (C). During testing, the urine or serum 1. Allow test devices and urine or serum samples to equilibrate
sample reacts with the dye conjugate (mouse anti-hCG anti- to room temperature (20-30°C) prior to testing.
body-colloidal gold conjugate) which has been pre-coated in 2. Remove the PREGTEST II from foil pouch. Use device as
the test device. The mixture migrates upward on the mem- soon as possible within 1 hour after removal from pouch spe-
brane chromatographically by capillary action to react with cially if the room temperature is more than 30°C or in high
anti-hCG antibodies on the membrane and generate a red line. humidity environment.
Presence of this red line indicates a positive result, while its 3.Holding the dropper vertically, dispense 5 full drops of spe-
absence indicates a negative result. Regardless of the pre- cimen (~200 µl) without air bubbles into the sample well of the
sence of hCG, as the mixture continues to migrate across the test device.
membrane to the immobilized goat anti-mouse region, a red 4. Wait for red line(s) to appear. It is significant that the back-
line at the control line region (C) will always appear. The pre- ground is clear before reading the test, specially when samples
sence of this red line serves as verification for sufficient sam- have low hCG concentration, and only a weak line appears in
ple volume and proper flow and as a control for the reagents. the test region (T).
5. Depending of the concentration of hCG, positive results may
PROVIDED MATERIAL be observed within 40 seconds. To confirm negative results on
The device consists in a reaction membrane inserted in a plas- serum and urine, it is necessary to wait for a complete migra-
tic case. It is packaged in a sealed foil pouch also containing a tion and reaction.
disposable sample dropper and a dessicant bag. The reading time is :
Result area - For serum (sensitivity at 10 mIU/mL) : 15 minutes
Control (C) and Test (T) Sample well
- For urine (sensitivity at 20 mIU/mL) : 5 minutes
INTERPRETATION OF RESULTS
1. If there is one coloured band on

both the (T) area and the (C) area,
C T C T
the test result is Positive.
(hCG has been detected).
2. If there is no distinct colour on

the (T) area other than the normal
background colour, and a coloured
C T
TEST band on the (C) area, the test result
is Negative.
STORAGE AND STABILITY
The device stored at 4-30°C in the sealed pouch is stable until .../...
the expiration date stated on the label. Do not freeze . (02/2005)
FTAN-RTHC2-3

PREGTEST II
NOTES: - Specificity :
The shade of red color in the test line region (T) will vary No cross-reaction was observed with the following hormones,
depending on the concentration of hCG present. However, at the following concentrations :
neither the quantitative value nor the rate of increase in hCG
can be determined by this qualitative test. hFSH 1 000 mU/mL (reference: 2nd IRP LH 80/552)
hLH 300 mU/mL (reference: 1st IRP FSH 92/510)
QUALITY CONTROL hTSH 1 000 µU/mL (reference: 1st IRP TSH 94/674)
Each reaction device has its own quality control indicator.
- Interferences :
After performing the test a coloured band has to appear on the
Studies have been performed to determine potential interfe-
(C) area. If not :
rences on negative and positive results.
• either the procedure has not been carefully followed None of the following substances interfere significantly up to
• or the reaction device has been deteriorated. the concentrations indicated below :
Repeat the test using a new reaction device.
Hemoglobin : 0.4 g/dL (4 g/L)
EXPECTED VALUES Bilirubin : 30 mg/dL (300 mg/L; 513 µmol/L)
hCG level concentration in urine and serum of pregnant Uric acid : 0.2 g/dL (2 g/L; 11.9 mmol/L)
Glucose : 2 g/dL (20 g/L; 110 mmol/L)
woman rises very rapidly, frequently exceeding 100 mIU/ml
Ascorbic acid : 20 mg/dL (200 mg/L)
after the first missed menstrual period and peaking in the
Acetaminophen : 20 mg/dL (200 mg/L)
30,000 - 100,000 mIU/ml range by 10-12 weeks into pre-
Salicylic acid : 20 mg/dL (200 mg/L)
gnancy.
Atropine : 20 mg/dL (200 mg/L)
LIMITATION OF THE TEST Caffeine : 20 mg/dL (200 mg/L)
1- If the test is negative or doubful whereas the pregnancy is Gentisic acid : 20 mg/dL (200 mg/L)
still suspected, repeat the test on a fresh specimen obtained
48-72 hours later and confirm by a quantitative test and/or BIBLIOGRAPHY
other clinical information.
2-Positive results can be observed in absence of pregnancy 1.Batzer FR. Fertility and Sterility 1980; 34:1.
for hCG concentrations close to 10 mIU/mL in the following 2.Catt KJ, Dufan ML, Vaitukaitis JL. J. Clin. Endocrinol.
cases : Metab. 1975; 40:537.
- Natural abortions 3.Baunstein GD, Rasor J, Adler D, Danzer H, Wade ME. Am.
- Elevated physiological hCG levels of non-pregnant women J. Obstet. Gynecol. 1976; 126:678.
- Drugs comprising hCG 4.Lenton EA, Neal LM, Sulaiman R. Fertility and Sterility
3- Patients with trophoblastic or non-trophoblastic diseases 1982; 37:773.
(breast cancer, testicular tumors, prostate cancer, lung can- 5.Engvall E. Methods in Enzymology 1980; 70:419.
cer, etc...) may have elevated hCG levels which could give 6.Uotila M, Ruoslahti E, Engvall EJ. E. J. Immunol. Methods
positive results in absence of pregnancy. 1981; 42:11.
4- False- negative can occur for very high concentrations of 7.Steier JA, Bergsjo P, Myking OL. Am. J. Obstet. Gynecol.
hCG (> 600 000 mIU/mL). 1984; 64:391.
8.Dawood MY, Saxena BB, Landesman R. Am. J. Obstet.
PERFORMANCE CHARACTERISTICS Gynecol. 1977; 50:172.
- Sensitivity : 9.Braunstein GD, Vaitukaitis JL, Carbone PP. Ann. Inter.
Urine : 20 mU/mL Med. 1973; 78:39.
Serum : 10 mU/mL
The sensitivity has been tested according to the reference SYMBOLS USED ON THE LABELS:
material WHO 4th IRP hCG (75/589).
Lot Number
- Precision :
Urine : Comparative Studies were performed on 130 positive Consult instruction for use
and 178 negative urine specimens using
PREGTEST II versus a reference hCG rapid test. In vitro diagnostic medical device
Both studies demonstrated a 100% correlation.
Serum : Comparative Studies were performed on 169 positive Manufacturer’s address
and 250 negative serum specimens using PREGTEST II ver-
sus a reference hCG rapid test. Both studies demonstrated a Temperature limitation
100 % correlation.
Expiration date
Do not reuse (02/2005)

FTAN-RTHC2-3

RAPIDROG II
Amphetamine
For in vitro diagnostic use only Ref : RTAM-0015 15 tests
CLINICAL SIGNIFICANCE STORAGE AND STABILITY

The amphetamine derivatives are powerful stimulants of the Cen-tral The device stored at 2-30°C is stable until the expiration date state on
Nervous System (CNS), whose sympathomimetic properties are used the label.
with amounts therapeutic for their appetite suppression and stimu-
lant action. With stronger amounts (therapeutic deviations, drug-
addiction), this stimulation produces effects known as "positive": SPECIMEN COLLECTION
euphoria, intellectual promptness, physical excitation, feeling of abo- Fresh urine does not require any special handling or pretreatment.
lished tiredness and self-confidence, followed by other symptoms Urine samples should be collected such that testing can be performed
(descent), anxiety, cardiac disturb, mental confusion, psychoses. as soon as possible after the specimen collection, preferably during
In addition to amphetamine and metamphetamine, compounds such the same day.
as methylene-dioxyamphetamine (MDA) and 3,4-methylene-dioxyme- Urine specimens and all materials coming in contact with them
tamphetamine (MDMA or "ECSTASY") also exist and are abused should be handled and disposed of as if capable of transmitting infec-
Generally taken by oral way, nasal catch or by intravenous, the tion.
amphetamines have a fast effect (2 to 4 hours after the catch). The Specimen storage:
amphetamine, whose it half life is 4 to 24 hours, is partially metabo- The specimen may be refrigerated at 2-8°C for 2 days, or frozen at
lized by the liver (by oxidative desamination and hydroxylation). -20°C for a longer period of time. Specimens that have been refrigera-
About 30% of amphetamine is excreted in the urine in unchanged ted must be equilibrated to room temperature prior to testing.
form. (Methamphetamine is metabolized in amphetamine, but 10 to Specimens previously frozen must be thawed, equilibrated to room
20% is also excreted in unchanged form). So metabolites (benzoic temperature, and mixed thoroughly prior to testing.
acid, hippurate…) and mother compounds are found in urines. It
should be noted that the proportion amphetamine/metabolites PROVIDED MATERIAL
depends on the urinary pH, the quantity of un-changed drug being The device consists in a reaction membrane inserted in a plastic case.
more significant with acid pH. The duration of detection in the urine It is packaged in a sealed foil pouch also containing a disposable sam-
is 48 hours; however it can reach 3 to 5 days according to urinary pH. ple dropper and a desiccant bag.
METHOD
Immuno-chromatography Result area
Qualitative Control (C) Test (T) Sample well
PRINCIPLE
The Rapidrog II-Amphetamine (AMP) is a rapid immunoassay for the
qualitative detection of d-amphetamine in human urine at a cut-off C T
concentration of 1000 ng/mL, before confirmation with a reference
method. The membrane is pre-coated with drug conjugate on the test
band (T) and a colored mouse anti-amphetamine mono-clonal anti-
body-colloidal gold conjugate pad is placed at the right end. In the
absence of drug in the urine, the conjugated anti-amphetamine
monoclonal-colloidal gold moves upward on the membrane chromato-
graphically by capillary action, to react with the immobilized drug
conjugate zone (T) and generate a red line. Presence of the colored line
indicates a negative result, while its absence indicates a positive TEST PROCEDURE
result. 1. Allow test devices and urine sample to equilibrate to room tempe-
When the drug is present in the urine, it competes with the antigen rature (20-30°C) prior to testing. Do not open pouches until ready to
on the test band (T) for limited gold conjugate. When a sufficient perform the assay.
concentration of drug is present, it will fill the limited antibody bin-
ding sites. This will prevent attachment of the colored antibody-colloi- 2. Remove the test device from foil pouch (bring the device to room
dal gold conjugate to the drug conjugate zone on the test band region. temperature before opening the pouch to avoid condensation of mois-
A control band with a different antigen/antibody reaction is also ture on the membrane).
added to the immunochromatographic membrane strip at the control
region (C) to indicate that the test has performed properly. 3. Holding the dropper vertically, dispense 3 full drops of specimen (~
120 µl) without air bubbles into the sample well of the test de-vice.
Cut-off: Use a separate pipette and device for each sample or control (to avoid
- The cut-off concentration of the test Rapidrog II-Amphetamine is cross-contamination).
1000 ng/mL.
- The method of reference for the confirmation of the presence or the 4. Read result between 3 to 8 minutes after the addition of sample.
absence of amphetamine in the urines is Gas Chromatography cou- Do not read result after 8 minutes.
pled with the Mass Spectrometry (GC/MS). This technique detects
and quantifies in a specific way amphetamine (d, l) and derivates.
NIDA (National In statue on Drug Abuse) recommends cut-off concen-
tration of 500 ng/ml for amphetamine for the GC/MS.
…/…
(01/2004)
FTAN-RTAM-2

RAPIDROG II
Amphetamine
* Specificity:
QUALITY CONTROL The specificity for the Rapidrog II - Amphetamine was tested by
The result is invalid if no line appears in the control region. Under no adding various substances in drug-free normal human urines.
circumstances should a positive sample be identified until the control The following compounds produced positive results when tested at
line forms in the viewing area. If the control line does not form, the levels equal to or greater than the concentrations listed below:
test result is inconclusive, the test should be repeated.
Good laboratories practice recommends the use of control materials d-amphetamine 1000 ng/mL
to ensure proper kit performance. l-amphetamine 20000 ng/mL
(+/-)3,4-methylene-dioxyamphetamine 1000 ng/mL
Methylene-dioxymethamphetamine 10000 ng/mL
RESULTS
1. If two colored lines appear, one in the test C T The following compounds produced negative results when tested at
region, the other in the control region, the 100 µg/mL:
result is NEGATIVE. Intensity of lines could be Acetone, Acetamidophen, Albumin, Amitriptyline, Ampicillin, As-par-
different, and even if the line in the test region tame, Aspirin, Atropine, Benzocaine, Bilirubin, Caffeine, Chloroquine,
(T) is very weak, the result must be interpreted (+/-)-Chlorpheniramine,Chlorpheniramine,Creatine,
such as negative. Dexbrompheniramine,Dextromethorphan,4-
C T Dimethylaminoantipyrine, Dopamine, Erythromycin, Ethanol,
2. If only one colored line appears in the Furosemide, Glucose, Guaiacol Glyceryl Ether, Hemoglobin,
control region (C), the result is POSITIVE. Imipramine, (+/-)-Isoproterenol, Lidocaine, (+)-Naproxen, Oxalic Acid,
The absence of a test line indicates a positive Penicillin-G, Pheniramine, Phenothiazine, Phenylethylamine,
result. Procaine, Quinidine, Ranitidine, Riboflavin, Sodium Chloride,
Sulindac, Thioridazine, Trifluoperazine, Trimethobenzamide,
LIMITATION OF THE TEST Tyramine, Vitamin C.
1.Warning : A positive result with any of the tests indicates the pre-
sence of a drug/metabolite only, and does not indicate or meas-ure BIBLIOGRAPHY
intoxication. This immunological assay is qualitative; and provides 1.Baselt, R.C., Disposition of Toxic Drugs and Chemicals in Man,
only a preliminary analytical test result. This result can-not be used Biomedical Publications, (1982).
for any legal consequence. A more specific alternative chemical 2.Urine Testing for Drugs of Abuse. National Institute on Drug Abuse
method like GC/MS (preferred confirmatory method) must be used in (NIDA), Research Monograph 73, (1986).
order to obtain a confirmed analytical result. Clinical consideration 3.Fed. Register, Department of Health and Human Services, Man-
and professional judgment should be applied to any drug. datory Guidelines for Federal Workplace Drug Testing Programs,
(1988), 53, 69, 11970.
2.If it is suspected that the samples have been tampered with, a new 4.McBay, A.J., Clin. Chem. (1987), 33, 33.
specimen should be collected and the test should be repeated. If a cli- 5.Gilman, A.G., Goodman, L.S.,The Pharmacological Basis of
nician has some indication that the urine be adulterated, there are Therapeutics, (eds. MacMillan Publishing, New York, NY), (1980).
available test devices detecting the manipulation. 6.Porter, W.H., Moyer, T.P., Clinical Toxicology. Tietz Fundamentals of
Clinical Chemistry, 5th Ed., Burtis, C.A. & Ashwood, E.R. (W.B.
3.There is a possibility that technical or procedural errors as well as Saunders eds. Philadelphia USA), (2001), 636.
other substances and factors not listed may interfere with the test 7.AGSA, Drugs of Abuse Testing Guidelines, www.consilia-sa.ch/agsa
and cause wrong results. See SPECIFICITY.

PERFORMANCES
* Accuracy:
Lot Number
1. Sensitivity:
20 urines samples detected positive with GC/MS were all deter-mined
positive with the test Rapidrog II-Amphetamine. The sensitivity of the
test Rapidrog II-Amphetamine compared to GC/MS is higher than
99%.
2. Specificity:
50 urines samples detected negative with another immunological Temperature limitation
technique of tracking (EMIT) were all determined negative with the
test Rapidrog II-Amphetamine. The specificity of the test Rapidrog II- Expiration date
Amphetamine compared to EMIT method is higher than 99%.
Do not reuse
* Reproducibility:
The reproducibility of the Rapidrog II-Amphetamine was evaluated on
3 different batches, by adding d-amphetamine in drug-free normal
urines. All controls carried out are in conformity, and identical bet- (01/2004)
ween them. FTAN-RTAM-2

RAPIDROG II
Barbiturates
For in vitro diagnostic use only Ref : RTBA-0015 15 tests

Barbiturates suppress neuronal activity of Central Nervous System The device stored at 2-30°C is stable until the expiration date state on
(CNS) and thus have sedative and hypnotic properties. Phenobarbital the label.
is a long acting barbiturate derivative that has been used as a seda-
tive and more widely as an anticonvulsant. Because of their rapid
onset and short duration of action, the short- to intermediate-acting SPECIMEN COLLECTION
barbiturates are used as sedative-hypnotic (amorbital, butarbital, Fresh urine does not require any special handling or pretreatment.
butalbital, pentarbital, secobarbital). These compounds are abused Urine samples should be collected such that testing can be performed
most commonly. The longer acting barbiturates (phenorbital), used as soon as possible after the specimen collection, preferably during
primarily for their anticonvulsive properties, are abused rarely. So, the same day.
barbiturates continue to be subject to abuse and are a source of Urine specimens and all materials coming in contact with them
intentional intoxication. The major manifestations of barbiturates should be handled and disposed of as if capable of transmitting infec-
intoxication are CNS depression, cardiovascular and respiratory tion.
depression too. Severe intoxication leads to coma, hypothermia, hypo- Specimen storage:
tension, and cardiorespiratory failure Barbiturates are swallowed, The specimen may be refrigerated at 2-8°C for 2 days, or frozen at
taken rectally, or by intravenous and intramuscular injection. -20°C for a longer period of time. Specimens that have been refrigera-
The short- to intermediate-acting barbiturate generally may be detected must be equilibrated to room temperature prior to testing.
ted for 1 to 4 days after use; long-acting barbiturates, such as Specimens previously frozen must be thawed, equilibrated to room
Phenobarbital, may be detected for several weeks after chronic use. temperature, and mixed thoroughly prior to testing.
METHOD PROVIDED MATERIAL

Immuno-chromatography The device consists in a reaction membrane inserted in a plastic
Qualitative case. It is packaged in a sealed foil pouch also containing a dispo-
sable sample dropper and a desiccant bag.
PRINCIPLE Result area
The Rapidrog II-Barbiturates (BAR) is a rapid immunoassay for the Control (C) Test (T) Sample well
qualitative detection of Barbiturates in human urine at a cut-off
band (T) and a colored mouse anti-barbiturates monoclonal antibody-
colloidal gold conjugate pad is placed at the right end. In the absence
C T
of drug in the urine, the conjugated anti-barbiturates monoclonal-col-
loidal gold moves upward on the membrane chromatographically by
capillary action, to react with the immobilized drug conjugate zone (T)
and generate a red line. Presence of the colored line indicates a nega-
tive result, while its absence indicates a positive result. When the
drug is present in the urine, it competes with the antigen on the test
band (T) for limited gold conjugate. TEST PROCEDURE
When a sufficient concentration of drug is present, it will fill the limi- 1. Allow test devices and urine sample to equilibrate to room tempe-
ted antibody binding sites. This will prevent attachment of the colored rature (20-30°C) prior to testing. Do not open pouches until ready to
antibody-colloidal gold conjugate to the drug conjugate zone on the perform the assay.
test band region.
A control band with a different antigen/antibody reaction is also 2. Remove the test device from foil pouch (bring the device to room
added to the immunochromatographic membrane strip at the control temperature before opening the pouch to avoid condensation of mois-
region (C) to indicate that the test has performed properly. ture on the membrane).
Cut-off: 3. Holding the dropper vertically, dispense 3 full drops of specimen (~

- The cut-off concentration of the test Rapidrog II-Barbiturates is 300 120 µl) without air bubbles into the sample well of the test device. Use
ng/mL. a separate pipette and device for each sample or control (to avoid
- The method of reference for the confirmation of the presence or the cross-contamination).
absence of barbiturates (and/or its metabolites) in the urines is Gas
Chromatography coupled with Mass Spectrometry (GC/MS). This 4. Read result between 3 to 8 minutes after the addition of sample.
method detects and quantifies in a specific way barbiturates. AGSA Do not read result after 8 minutes.
(Swiss Working Group for Drugs Abuse Testing Guidelines) recom-
mends cut-off concentrations of 200 ng/ml for barbiturates for the
GC/MS.
…/…
(02/2004)
FTAN-RTBA-2

RAPIDROG II
Barbiturates
QUALITY CONTROL * Specificity:

The result is invalid if no line appears in the control region. Under no The specificity for the Rapidrog II-Barbiturate was tested by adding
circumstances should a positive sample be identified until the control various substances in drug-free normal human urines.
line forms in the viewing area. If the control line does not form, the The following compounds produced positive results when tested at
test result is inconclusive and the test should be repeated. levels equal to or greater than the concentrations listed below:
Good laboratories practice recommends the use of control materials Amobarbital 300 ng/mL
to ensure proper kit performance. Aprobarbital 50 ng/mL
Butabarbital 500 ng/mL
RESULTS Butalbital 500 ng/mL
Pentobarbital 100 ng/mL
1. If two colored lines appear, one in the test C T Phenobarbital 100 ng/mL
region, the other in the control region, the
result is NEGATIVE. Intensity of lines could be The following compounds produced negative results when tested at
different, and even if the line in the test region 100 µg/mL:
(T) is very weak, the result must be interpreted Acetone, Acetamidophen, Albumin, Amitriptyline, Ampicillin,
such as negative. Aspartame, Aspirin, Atropine, Benzocaine, Bilirubin, Caffeine,
Chloroquine, (+/-)-Chlorpheniramine, Chlorpheniramine, Creatine,
2. If only one colored line appears in the C T Dexbrompheniramine, Dextromethorphan, 4-Dimethylamino-antipy-
control region (C), the result is POSITIVE. rine, Dopamine, Erythromycin, Ethanol, Furosemide, Glucose,
The absence of a test line indicates a positive Guaiacol Glyceryl Ether, Hemoglobin, Imipramine, (+/-)-
result. Isoproterenol, Lidocaine, (+)-Naproxen, Oxalic Acid, Penicillin-G,
Pheniramine, Phenothiazine, Phenylethylamine, Procaine, Quinidine,
LIMITATION OF THE TEST Ranitidine, Riboflavin, Sodium Chloride, Sulindac, Thioridazine,
1.Warning : A positive result with any of the tests indicates the pre- Trifluoperazine, Trimethobenzamide, Tyramine, Vitamin C.
sence of a drug/metabolite only, and does not indicate or measure
intoxication. This immunological assay is qualitative; and provides
BIBLIOGRAPHY
only a preliminary analytical test result. This result cannot be used
1.Baselt, R.C., Disposition of Toxic Drugs and Chemicals in Man,
for any legal consequence. A more specific alternative chemical
Biomedical Publications, (1982).
method like GC/MS (reference method) must be used in order to
2.Urine Testing for Drugs of Abuse. National Institute on Drug Abuse
obtain a confirmed analytical result. Clinical consideration and pro-
(NIDA), Research Monograph 73, (1986).
fessional judgment should be applied to any drug.
3.Fed. Register, Department of Health and Human Services,
Mandatory Guidelines for Federal Workplace Drug Testing Programs,
2.If it is suspected that the samples have been tampered with, a new
(1988), 53, 69, 11970.
specimen should be collected and the test should be repeated. If a cli-
4.Ellenhorn, M.J., Barceloux, D.G., Medical Toxicology. (New York,
nician has some indication that the urine be adulterated, there are
Elsevier Science Publishing Company Inc.), (1988), 575.
available test devices detecting the manipulation.
5.Hofmann, F.E., A Handbook on Drug and Alcohol Abuse, The
Biomedical Aspects, New York. Oxford University Press, (1983).
3.There is a possibility that technical or procedural errors as well as
6.Porter, W.H., Moyer, T.P., Clinical Toxicology. Tietz Fundamentals of
other substances and factors not listed may interfere with the test
7.AGSA, Drugs of Abuse Testing Guidelines, www.consilia-sa.ch/agsa
PERFORMANCES
* Accuracy: SYMBOLS USED ON THE LABELS:
1. Sensitivity:
20 urines samples detected positive with GC/MS were all determined
Lot Number
positive with the test Rapidrog II-Barbiturates. The sensitivity of the
test Rapidrog II-Barbiturates compared to GC/MS is higher than
99%.
2. Specificity:
8 urines samples detected negative with GC/MS were all determined
negative with the test Rapidrog II-Barbiturates. The specificity of the
test Rapidrog II-Barbiturates compared to GC/MS is higher than
99%.
Expiration date
* Reproducibility:
The reproducibility of the Rapidrog II-Barbiturates was evaluated on Do not reuse
3 different batches, by adding secobarbital in drug-free normal uri-
nes. All controls carried out are in conformity, and identical between
them.
(02/2004)
FTAN-RTBA-2

RAPIDROG II
Benzodiazepines
For in vitro diagnostic use only Ref : RTBZ-0015 15 tests
CLINICAL SIGNIFICANCE SPECIMEN COLLECTION

Benzodiazepines are a class of drugs widely used in medicine as Fresh urine does not require any special handling or pretreatment.
depressors of the Central Nervous system (SNC). Benzodiazepines Urine samples should be collected such that testing can be performed
have various properties: anxiolytic, sedative hypnotic and anticon- as soon as possible after the specimen collection, preferably during
vulsant. Benzodiazepines also act like muscular relaxant with thera- the same day.
peutic amount, and produce with higher amounts intoxication simi- Urine specimens and all materials coming in contact with them
lar to the effects of alcohol. They can be taken orally or some-times should be handled and disposed of as if capable of transmitting infec-
by injection. The majority of benzodiazepines is metabolized in the tion.
liver into active and inactive metabolites. Then they are excreted in Specimen storage:
the urines in form of oxazepam glucuroned (inactive compound). The The specimen may be refrigerated at 2-8°C for 2 days, or frozen at
others have products of biotransformation chemically close to the ini- -20°C for a longer period of time. Specimens that have been refrigera-
tial molecule. The triazolobenzodiazepines (alprazolam and triazolam) ted must be equilibrated to room temperature prior to testing.
are hydroxylated and eliminated in glucuronide form. Lorazepam is Specimens previously frozen must be thawed, equilibrated to room
excreted in unchanged form (free or glucurnide). Clonazepam and temperature, and mixed thoroughly prior to testing.
Nitrazepam are transformed into amino-7derived. Symptoms of
dependence (physical and psychic) and withdrawal symptoms will
occur with long term use (insomnia, agitation, irritability, muscle ten- PROVIDED MATERIAL
sion, psychosis). The device consists in a reaction membrane inserted in a plastic case.
Benzodiazepines are detectable from a few days to several months It is packaged in a sealed foil pouch also containing a disposable sam-
(especially after regular consumption). ple dropper and a desiccant bag.
METHOD Result area

Control (C) Test (T) Sample well
Immuno-chromatography
Qualitative
PRINCIPLE
The Rapidrog II-Benzodiazepines (BZO) is a rapid immunoassay for C T
the qualitative detection of benzodiazepines in human urine at a cut-
off of 300 ng/mL (determined for Oxazepam), before confirmation with
a reference method. The membrane is pre-coated with drug conjugate
(Oxazepam) on the test band (T) and a colored mouse anti-BZO
(Oxazepam) monoclonal antibody-colloidal gold conjugate pad is pla-
ced at the right end. In the absence of drug in the urine, the conjuga-
ted anti-benzodiazepines monoclonal-colloidal gold moves upward on
the membrane chromatographically by capillary action, to react with TEST PROCEDURE
the immobilized drug conjugate zone (T) and generate a red line. 1. Allow test devices and urine sample to equilibrate to room tem-
Presence of the colored line indi-cates a negative result, while its perature (20-30°C) prior to testing. Do not open pouches until ready
absence indicates a positive result. When the drug is present in the to perform the assay.
urine, it competes with the antigen on the test band (T) for limited
gold conjugate. 2. Remove the test device from foil pouch (bring the device to room
When a sufficient concentration of drug is present, it will fill the limi- temperature before opening the pouch to avoid condensation of mois-
ted antibody binding sites. This will prevent attachment of the colored ture on the membrane).
antibody-colloidal gold conjugate to the drug conjugate zone on the
test band region. 3. Holding the dropper vertically, dispense 3 full drops of specimen
A control band with a different antigen/antibody reaction is also (~ 120 µl) without air bubbles into the sample well of the test de-vice.
added to the immunochromatographic membrane strip at the control Use a separate pipette and device for each sample or control (to avoid
region (C) to indicate that the test has performed properly. cross-contamination).
Cut-off : 4. Read result between 3 to 8 minutes after the addition of sample.

- The cut-off concentration of the test Rapidrog II-Benzodiazepines is Do not read result after 8 minutes.
300 ng/mL (determined for Oxazepam).
- The method of reference for the confirmation of the presence or the QUALITY CONTROL
absence of benzodiazepines (and/or its metabolites) in the urines is The result is invalid if no line appears in the control region. Under no
Gas Chromatography coupled with the Mass Spectrome-try (GC/MS). circumstances should a positive sample be identified until the control
This technique detects and quantifies in a specific way benzodiazepi- line forms in the viewing area. If the control line does not form, the
nes and metabolites. No cut-off concentrations for benzodiazepines test result is inconclusive and the test should be repeated.
are set actually for GC/MS. Good laboratories practice recommends the use of control materials
to ensure proper kit performance.
STORAGE AND STABILITY
The device stored at 2-30°C is stable until the expiration date state on
the label. …/…
(02/2004)
FTAN-RTBZ-2

RAPIDROG II
Benzodiazepines
RESULTS - Diazepam 200 ng/mL

- Lormetazepam 1 000 ng/mL
1. If two colored lines appear, one in the test C T - Clonazepam 2 000 ng/mL
region, the other in the control region, the - Clorazepate 2 000 ng/mL
result is NEGATIVE. Intensity of lines could be - Flurazepam 10 000 ng/mL
different, and even if the line in the test region - Prazepam 10 000 ng/mL
(T) is very weak, the result must be interpreted - Medazepam 50 000 ng/mL
such as negative.
C T The following compounds produced negative results when tested at
2. If only one colored line appears in the
100 µg/mL:
control region (C), the result is POSITIVE.
Acetone, Acetamidophen, Albumin, Amitriptyline, Ampicillin, Aspar-
The absence of a test line indicates a positive
tame, Aspirin, Atropine, Benzocaine, Bilirubin, Caffeine, Chloro-
result.
quine, (+/-)-Chlorpheniramine, Chlorpheniramine, Creatine, Dex-
brompheniramine, Dextromethorphan, 4-Dimethylaminoantipyrine,
LIMITATION OF THE TEST Dopamine, Erythromycin, Ethanol, Furosemide, Glucose, Guaiacol
1.Warning : A positive result with any of the tests indicates the pre- Glyceryl Ether, Hemoglobin, Imipramine, (+/-)-Isoproterenol, Lido-
sence of a drug/metabolite only, and does not indicate or meas-ure caine, (+)-Naproxen, Oxalic Acid, Penicillin-G, Pheniramine, Phe-
intoxication. This immunological assay is qualitative; and provides nothiazine, Phenylethylamine, Procaine, Quinidine, Ranitidine,
only a preliminary analytical test result. This result cannot be used Riboflavin, Sodium Chloride, Sulindac, Thioridazine, Trifluoperazine,
for any legal consequence. A more specific alternative chemical Trimethobenzamide, Tyramine, Vitamin C.
method like GC/MS (reference method) must be used in order to
BIBLIOGRAPHY
2.If it is suspected that the samples have been tampered with, a new Biomedical Publications, (1982).
specimen should be collected and the test should be repeated. If a cli- 2.Urine Testing for Drugs of Abuse. National Institute on Drug Abuse
nician has some indication that the urine be adulterated, there are (NIDA), Research Monograph 73, (1986).
available test devices detecting the manipulation. 3.Fed. Register, Department of Health and Human Services, Manda-
tory Guidelines for Federal Workplace Drug Testing Programs, (1988),
53, 69, 11970.
4.McBay, A.J., Clin. Chem. (1987), 33, 33.
5.Gilman, A.G., & Goodman, L.S., The Pharmacological Basis of
Therapeutics, (MacMillan Publishing eds., New York, NY), (1980).
PERFORMANCES 6.Greenblatt, D.J., Shader, R.I., Benzodiazepines in Clinical Prac-tice.
* Accuracy: (New York, Raven Press), (1974).
1. Sensitivity: 7.Harvey, R.A., Champe, P.C., Lippincott's illustrated Reviews.
On 21 urines samples detected positive with GC/MS, 20 samples Pharmacology, (1992), 91.
were determined positive with the test Rapidrog II-Benzodiazepine. 8.Porter, W.H., Moyer, T.P., Clinical Toxicology. Tietz Fundamentals of
The sensitivity of the test Rapidrog II-Benzodiazepine compared to Clinical Chemistry, 5th Ed., Burtis, C.A. & Ashwood, E.R. (W.B.
GC/MS is higher than 95%. Saunders eds. Philadelphia USA), (2001), 636.
2. Specificity:
8 urines samples detected negative with GC/MS were all determined SYMBOLS USED ON THE LABELS:
negative with the test Rapidrog II-Benzodiazepine. The specificity of
the test Rapidrog II- Benzodiazepine compared to GC/MS is higher
than 99%. Lot Number
* Reproducibility: Consult instruction for use

The reproducibility of the Rapidrog II-Methadone was evaluated on 3
different batches, by adding oxazepam in drug-free normal urines. All
controls carried out are in conformity, and identical between them.
* Specificity:
The specificity for the Rapidrog II-Benzodiazepine was tested by
adding various substances in drug-free normal human urines.
Expiration date
The following compounds produced positive results when tested at
levels equal to or greater than the concentrations listed below:
Do not reuse
- Oxazepam 300 ng/mL - Estazolam 500 ng/mL
- Alprazolam 500 ng/mL - Flunitrazepam 200 ng/mL
- Bromazepam 800 ng/mL - Lorazepam 500 ng/mL
- Chlordiazepoxide 100 ng/mL - Nitrazepam 200 ng/mL
- Clobazam 100 ng/mL - Temazepam 500 ng/mL (02/2004)
- Delorazepam 100 ng/mL - Triazolam 500 ng/mL FTAN-RTBZ-2

RAPIDROG II
Cocaine
For in vitro diagnostic use only Ref : RTCO-0015 15 tests
CLINICAL SIGNIFICANCE This method detects and quantifies in a specific way benzoylecgonine
Cocaine or methylbenzoylecgonine is a natural alkaloid extracted but also ester methyl-ecgonine, ecgonine. NIDA (National Institue on
from the sheets of the Coka. It is a powerful stimulating Central Drug Abuse) recommends cut-off concentration of 150 ng/mL for
Nervous System (CNS), its sympathico-mimetic properties similar to benzoylecgonine for GC/MS.
the action of the amphetamines make of it a dangerous drug. Its the-
rapeutic applications like local anaesthetic are renounced because of STORAGE AND STABILITY
these addictive effects. This stimulation leads to a state of euphoria, The device stored at 2-30°C is stable until the expiration date state on
of physical and intellectual excitation, by a feeling of abolished tired- the label.
ness, self-confidence (effects known as "positive") and is accompanied
by physical demonstrations such as dilation by the pupils, tremors, SPECIMEN COLLECTION
fever and sweats. Its strong toxicity associated with the psychological Fresh urine does not require any special handling or pretreatment.
effects involves the appearance of the following symptoms: anxiety, Urine samples should be collected such that testing can be performed
mental confusion, psychosis, convulsions and disorders cardiac. As as soon as possible after the specimen collection, preferably during
for any addictive substance the tolerance with cocaine is significant the same day.
and induces the need for increasing the amounts to obtain the initial Urine specimens and all materials coming in contact with them
effect. The dependence which it involves is more psychic than physi- should be handled and disposed of as if capable of transmitting infec-
cal. Cocaine can either be smoked (cocaine bases or ace) or "sniff" (cut tion.
hydrochlorate of cocaine) or injected by venous way (only or mixed Specimen storage:
with heroin), more rarely swallowed. The effects are intense but short. The specimen may be refrigerated at 2-8°C for 2 days, or frozen at
The cocaine, whose half-life is half hour at one hour and half, is -20°C for a longer period of time. Specimens that have been refrigera-
quickly metabolized by the liver mainly in benzoylecgonine, methyl ted must be equilibrated to room temperature prior to testing.
ecgonine ester and ecgonine. The norcocaine obtained by demethyla- Specimens previously frozen must be thawed, equilibrated to room
tion appears only in the cases of acute intoxication (overdose). These temperature, and mixed thoroughly prior to testing.
different metabolites are the mainly, which are excreted in the urine
a few hours after the catch. The duration of detection of cocaine PROVIDED MATERIAL
(trace) in the urine is very short; on the other hand the time of reten- The device consists in a reaction membrane inserted in a plastic case.
tion of its metabolites in particular for the benzoylecgonine is 24 to 96 It is packaged in a sealed foil pouch also containing a disposable sam-
hours. ple dropper and a desiccant bag.
METHOD Result area

Control (C) Test (T) Sample well
Qualitative
PRINCIPLE
The Rapidrog II-Cocaine (COC) is a rapid immunoassay for the quali- C T
tative detection of benzoylecgonine in human urine at a cut-off
band (T) and a colored mouse anti-cocaine monoclonal antibody-col-
loidal gold conjugate pad is placed at the right end. In the absence of
drug in the urine, the conjugated anti-cocaine monoclonal-colloidal
gold moves upward on the membrane chromatographically by capil- TEST PROCEDURE
lary action, to react with the immobilized drug conjugate zone (T) and 1. Allow test devices and urine sample to equilibrate to room tempe-
generate a red line. Presence of the colored line indicates a negative rature (20-30°C) prior to testing. Do not open pouches until ready to
result, while its absence indicates a positive result. When the drug is perform the assay.
present in the urine, it competes with the antigen on the test band (T)
for limited gold conjugate. 2. Remove the test device from foil pouch (bring the device to room
When a sufficient concentration of drug is present, it will fill the limi- temperature before opening the pouch to avoid condensation of mois-
ted antibody binding sites. This will prevent attachment of the colored ture on the membrane).
antibody-colloidal gold conjugate to the drug conjugate zone on the
test band region. 3. Holding the dropper vertically, dispense 3 full drops of specimen (~
A control band with a different antigen/antibody reaction is also 120 µl) without air bubbles into the sample well of the test device. Use
added to the immunochromatographic membrane strip at the control a separate pipette and device for each sample or control (to avoid
region (C) to indicate that the test has performed properly. cross-contamination).
Cut-off : 4. Read result between 3 to 8 minutes after the addition of sample.

- The cut-off concentration of the test Rapidrog II-Cocaine is 300 Do not read result after 8 minutes.
ng/mL.
- The method of reference for the confirmation of the presence or the
…/…
absence of cocaine (and/or its metabolites) in the urines is Gas
(01/2004)
Chromatography coupled with Mass Spectrometry (GC/MS).
FTAN-RTCO-2

RAPIDROG II
Cocaine

The result is invalid if no line appears in the control region. Under no The specificity for the Rapidrog II-Cocaine was tested by adding
Good laboratories practice recommends the use of control materials
to ensure proper kit performance. Benzoylecgonine 300 ng/mL
Cocaine 2000 ng/mL
Ecgonine 20000 ng/mL
RESULTS
result is NEGATIVE. Intensity of lines could be Acetone, Acetamidophen, Albumin, Amitriptyline, Ampicillin,
different, and even if the line in the test region Aspartame, Aspirin, Atropine, Benzocaine, Bilirubin, Caffeine,
(T) is very weak, the result must be interpreted Chloroquine, (+/-)-Chlorpheniramine, Chlorpheniramine, Creatine,
such as negative. Dexbrompheniramine, Dextromethorphan, 4-Dimethylamino-antipy-
C T rine, Dopamine, Erythromycin, Ethanol, Furosemide, Glucose,
Guaiacol Glyceryl Ether, Hemoglobin, Imipramine, (+/-)-
Isoproterenol, Lidocaine, (+)-Naproxen, Oxalic Acid, Penicillin-G,
result.
Ranitidine, Riboflavin, Sodium Chloride, Sulindac, Thioridazine,
Trifluoperazine, Trimethobenzamide, Tyramine, Vitamin C.
LIMITATION OF THE TEST
1.Warning : A positive result with any of the tests indicates the pre- BIBLIOGRAPHY
1.Baselt, R.C., Disposition of Toxic Drugs and Chemicals in Man.
Biomedical Publications, Davis, CA, (1982).
2.Urine Testing for Drugs of Abuse, National Institute on Drug. Abuse
method like GC/MS (preferred confirmatory method) must be used in
order to obtain a confirmed analytical result. Clinical consideration
and professional judgment should be applied to any drug.
(1988), 53, 69,11970,.
4.McBay, A.J., Clin. Chem. (1987), 33, 33.
5.Gilman, A. G., Goodman, L. S., The Pharmacological Basis of
Therapeutics, (MacMillan Publishing eds., New York, NY), (1980).
PERFORMANCES
* Accuracy: Lot Number
1. Sensitivity:
19 urines samples detected positive with GC/MS were all determined Consult instruction for use
positive with the test Rapidrog II-Cocaine. The sensitivity of the test
Rapidrog II-Cocaine compared to GC/MS is higher than 99%. In vitro diagnostic medical device
2. Specificity: Manufacturer’s address

52 urines samples detected negative with another immunological
technique of tracking (EMIT) were all determined negative with the Temperature limitation
test Rapidrog II-Cocaine. The specificity of the test Rapidrog II-
Cocaine compared to EMIT method is higher than 99%. Expiration date
* Reproducibility: Do not reuse

The reproducibility of the Rapidrog II-Cocaine was evaluated on 3 dif-
ferent batches, by adding benzoylecgonine in drug-free normal urines.
All controls carried out are in conformity, and identical between them.
(01/2004)
FTAN-RTCO-2

RAPIDROG II
Methadone

Ref : RTMT-0015 15 tests

Methadone is a synthesis derivative with pharmacological properties The device stored at 2-30°C is stable until the expiration date state on
close to opiates. Psycholeptic, its action on the Central Nervous the label.
System (CNS) results in morphinomimetic effects which are essen-
tially analgesic and sedative. With high doses, in addition to symp- SPECIMEN COLLECTION
toms such as miosis, hypotension, methadone leads to respiratory Fresh urine does not require any special handling or pretreatment.
depression which can be mortal (overdose). Some galenic forms were Urine samples should be collected such that testing can be performed
used for these analgesics and antitussive properties, but currently, as soon as possible after the specimen collection, preferably during
methadone is primarily used in the treatments of substitution of the same day.
heroin. It induces dependence less significant than opiates. This Urine specimens and all materials coming in contact with them
dependence is as well physical as psychic and results in a state of should be handled and disposed of as if capable of transmitting infec-
lack at the time of withdrawal. tion.
Methadone is swallowed or injected intravenously. In opposite to mor- Specimen storage:
phine or heroine, the metabolism of methadone is slow; its half-life The specimen may be refrigerated at 2-8°C for 2 days, or frozen at
varies 15 hours to 55 hours. Methadone is metabolised in EDDP (2- -20°C for a longer period of time. Specimens that have been refrigera-
ethylidene-1.5-dimethyl-3.3-diphenyl-pyrrolidine) which is then ted must be equilibrated to room temperature prior to testing.
metabolised in EMDP (2-ethyl-5-methyl-3.3-diphenyl-1-pyrroline). Specimens previously frozen must be thawed, equilibrated to room
Methadone and its principal metabolite (EDDP) are excreted in the temperature, and mixed thoroughly prior to testing.
urine and the faeces.
PROVIDED MATERIAL
METHOD The device consists in a reaction membrane inserted in a plastic case.
Immuno-chromatography It is packaged in a sealed foil pouch also containing a disposable sam-
Qualitative ple dropper and a desiccant bag.
PRINCIPLE Result area

The Rapidrog II - Methadone (MTD) is a rapid immunoassay for the Control (C) Test (T) Sample well
qualitative detection of methadone in human urine at a cut-off
band (T) and a colored mouse anti-methadone monoclonal antibody-
colloidal gold conjugate pad is placed at the right end.
C T
In the absence of drug in the urine, the conjugated anti-methadone
monoclonal-colloidal gold moves upward on the membrane chromato-
graphically by capillary action, to react with the immobilized drug
conjugate zone (T) and generate a red line. Presence of the colored line
indicates a negative result, while its absence indicates a positive
result.
When the drug is present in the urine, it competes with the antigen
on the test band (T) for limited gold conjugate. When a sufficient
TEST PROCEDURE
concentration of drug is present, it will fill the limited antibody bin- 1. Allow test devices and urine sample to equilibrate to room tempe-
ding sites. This will prevent attachment of the colored antibody-colloi- rature (20-30°C) prior to testing. Do not open pouches until ready to
dal gold conjugate to the drug conjugate zone on the test band region. perform the assay.
A control band with a different antigen/antibody reaction is also
added to the immunochromatographic membrane strip at the control 2. Remove the test device from foil pouch (bring the device to room
region (C) to indicate that the test has performed properly. temperature before opening the pouch to avoid condensation of mois-
ture on the membrane).
Cut-off :
- The cut-off concentration of the test Rapidrog II-Methadone is 300 3. Holding the dropper vertically, dispense 3 full drops of specimen (~
ng/ml. 120 µl) without air bubbles into the sample well of the test device. Use
- The method of reference for the confirmation of the presence or the a separate pipette and device for each sample or control (to avoid
absence of methadone (and/or its metabolites) in the urines is Gas cross-contamination).
Chromatography coupled with the Mass Spectrometry (GC/MS). This
technique detects and quantifies in a specific way methadone but also 4. Read result between 3 to 8 minutes after the addition of sample.
the EDDP and the EMDP. No cut-off concentration for methadone is Do not read result after 8 minutes.
set actually for GC/MS.
…/…
(02/2004)
FTAN-RTMT-2

RAPIDROG II
Methadone

The result is invalid if no line appears in the control region. Under no The specificity for the Rapidrog II-Methadone was tested by adding
to ensure proper kit performance. Methadol 500 ng/mL
2-ethylidene-1,5-dimethyle-3,3-diphenylpyrolidine 20000 ng/mL
RESULTS
The following compounds produced negative results when tested at
1. If two colored lines appear, one in the test C T 100 µg/mL:
region, the other in the control region, the Acetone, Acetamidophen, Albumin, Amitriptyline, Ampicillin,
result is NEGATIVE. Intensity of lines could be Aspartame, Aspirin, Atropine, Benzocaine, Bilirubin, Caffeine,
different, and even if the line in the test region Chloroquine, (+/-)-Chlorpheniramine, Chlorpheniramine, Creatine,
(T) is very weak, the result must be interpreted Dexbrompheniramine, Dextromethorphan, 4-Dimethylamino-antipy-
such as negative. rine, Dopamine, Erythromycin, Ethanol, Furosemide, Glucose,
C T Guaiacol Glyceryl Ether, Hemoglobin, Imipramine, (+/-)-
result.
LIMITATION OF THE TEST BIBLIOGRAPHY
Biomedical Publications, (1982).
2.Urine Testing for Drugs of Abuse. National Institute on Drug Abuse
method like GC/MS (method of reference) must be used in order to
(1988), 53, 69, 11970.
4.Gorodetzkym, C.W., Detection of Drugs of Abuse in Biological Fluids.,
Drug Addiction I, (Martin W.R. eds, New York, Springer Verlag).
5.Hofmann, F.E., A Handbook on Drug and Alcohol Abuse, The
Biomedical Aspects, New York. Oxford University Press, (1983).
PERFORMANCES SYMBOLS USED ON THE LABELS:

* Accuracy:
1. Sensitivity: Lot Number
19 urines samples detected positive with HPLC were all determined
positive with the test Rapidrog II-Methadone. The sensitivity of the Consult instruction for use
test Rapidrog II-Methadone compared to HPLC is higher than 99%.
2. Specificity:
11 urines samples detected negative with HPLC were all determined Manufacturer’s address
negative with the test Rapidrog II-Methadone. The specificity of the
test Rapidrog II-Methadone compared to HPLC is higher than 99%. Temperature limitation
* Reproducibility: Expiration date

The reproducibility of the Rapidrog II-Methadone was evaluated on 3
different batches, by adding methadone in drug-free normal urines.
Do not reuse
All controls carried out are in conformity, and identical between them.
(02/2004)
FTAN-RTMT-2

RAPIDROG II
Morphine
For in vitro diagnostic use only Ref : RTMO-0015 15 tests
CLINICAL SIGNIFICANCE - The method of reference for the confirmation of the presence or the
The term opiates (also called morphine derivatives) gathers various absence of morphinic derivatives in the urines is Gas
natural or semi alkaloids synthetic derived from opium, resin extrac- Chromatography coupled with Mass Spectrometry (GC/MS). This
ted from the soporific poppy (Papaver somniferum). Morphine is a technique detects and quantifies in a specific way free or glucuronide
powerful analgesic subjected to the regulation of the narcotics. morphine but also its derivatives. NIDA (National Institute on Drug
Codeine, codethyline and pholcodine (of semi-synthetic origin) and Abuse) recommends cut-off concentration of 300 ng/mL for morphine
opium (officinal, dyeing, syrups) are used in many pharmaceutical and codeine for GC/MS.
preparations for their antitussives or antidiarrheic properties.
However therapeutic deviations exist. The heroin (or diacetylmor- STORAGE AND STABILITY
phine) synthesized from morphine is only used at toxicomaniac ends. The device stored at 2-30°C is stable until the expiration date state on
The action of opiates on the Central Nervous System (depressors of the label.
the CNS) results in a state of euphoria, absence, anxiety, feeling to be
well, but with strong amounts or of prolonged use, their toxicity SPECIMEN COLLECTION
results in various effects: reduction in coordination, absence of will, Fresh urine does not require any special handling or pretreatment.
respiratory depression, hypothermia and coma. The morphinic deri- Urine samples should be collected such that testing can be performed
vatives tolerance is significant; it induces the need for increasing the as soon as possible after the specimen collection, preferably during
amounts to obtain the initial effect. The dependence is as well physi- the same day.
cal as psychic and results in a state of lack at the time of withdrawal. Urine specimens and all materials coming in contact with them
The opiates have a complexe metabolism, whose morphine represents should be handled and disposed of as if capable of transmitting infec-
the "major structure". Indeed it is as well the main metabolite of the tion.
others derived as their "precursor". Heroin is quickly metabolized in Specimen storage:
morphine (half life of a few minutes). Codeine (methyl-3-morphine), The specimen may be refrigerated at 2-8°C for 2 days, or frozen at
codethyline (ethyl-3 morphine) and pholcodine are also transformed -20°C for a longer period of time. Specimens that have been refrigera-
into morphine. Morphine is metabolized on morphine-3-glucuronide ted must be equilibrated to room temperature prior to testing.
(70%) by the liver. Free or glucuronide morphine (morphine-3-glucu- Specimens previously frozen must be thawed, equilibrated to room
ronide) and codeine are the main urinary metabolites. The duration temperature, and mixed thoroughly prior to testing.
of detection of morphine and these metabolites in the urine is 1 to 2
days. PROVIDED MATERIAL
The device consists in a reaction membrane inserted in a plastic case.
METHOD It is packaged in a sealed foil pouch also containing a disposable sam-
Immuno-chromatography ple dropper and a desiccant bag.
Qualitative
Result area
PRINCIPLE Control (C) Test (T) Sample well
The Rapidrog II-Morphine (MOR) is a rapid immunoassay for the qua-
litative detection of morphine in human urine at a cut-off concentra-
tion of 300 ng/mL, before confirmation with a reference method. The
membrane is pre-coated with drug conjugate on the test band (T) and C T
a colored mouse anti-morphine monoclonal antibody-colloidal gold
conjugate pad is placed at the right end. In the absence of drug in the
urine, the conjugated anti-morphine monoclonal-colloidal gold moves
upward on the membrane chromatographically by capillary action, to
react with the immobilized drug conjugate zone (T) and generate a red
line. Presence of the colored line indicates a negative result, while its
absence indicates a positive result. TEST PROCEDURE
When the drug is present in the urine, it competes with the antigen 1. Allow test devices and urine sample to equilibrate to room tempe-
on the test band (T) for limited gold conjugate. When a sufficient rature (20-30°C) prior to testing. Do not open pouches until ready to
concentration of drug is present, it will fill the limited antibody bin- perform the assay.
ding sites. This will prevent attachment of the colored antibody-colloi-
dal gold conjugate to the drug conjugate zone on the test band region. 2. Remove the test device from foil pouch (bring the device to room
A control band with a different antigen/antibody reaction is also temperature before opening the pouch to avoid condensation of mois-
added to the immunochromatographic membrane strip at the control ture on the membrane).
region (C) to indicate that the test has performed properly.
3. Holding the dropper vertically, dispense 3 full drops of specimen (~
Cut-off : 120 µl) without air bubbles into the sample well of the test device. Use
- The cut-off concentration of the test Rapidrog II-Morphine is 300 a separate pipette and device for each sample or control (to avoid
ng/mL. cross-contamination).
4. Read result between 3 to 8 minutes after the addition of sample.

Do not read result after 8 minutes.
…/…
(01/2004)
FTAN-RTMO-2

RAPIDROG II
Morphine
QUALITY CONTROL Morphine 300 ng/mL

The result is invalid if no line appears in the control region. Under no Codeine 300 ng/mL
circumstances should a positive sample be identified until the control Ethyl morphine 300 ng/mL
line forms in the viewing area. If the control line does not form, the Hydrocodone 500 ng/mL
test result is inconclusive and the test should be repeated. Hydromorphone 500 ng/mL
Good laboratories practice recommends the use of control materials Merperidine 30000 ng/mL
to ensure proper kit performance. Morphine-3-glucuronide 500 ng/mL
Oxycodone 15000 ng/mL
Thebaine 30000 ng/mL
RESULTS 6-Monoacetylmorphine 1000 ng/mL
1. If two colored lines appear, one in the test C T Oxymorphone 10000 ng/mL
region, the other in the control region, the Diacetyl morphine 1000 ng/mL
result is NEGATIVE. Intensity of lines could be
different, and even if the line in the test region The following compounds produced negative results when tested at
(T) is very weak, the result must be interpreted 100 µg/mL:
such as negative. Acetone, Acetamidophen, Albumin, Amitriptyline, Ampicillin,
Aspartame, Aspirin, Atropine, Benzocaine, Bilirubin, Caffeine,
2. If only one colored line appears in the C T Chloroquine, (+/-)-Chlorpheniramine, Chlorpheniramine, Creatine,
control region (C), the result is POSITIVE. Dexbrompheniramine, Dextromethorphan, 4-Dimethylamino-antipy-
The absence of a test line indicates a positive rine, Dopamine, Erythromycin, Ethanol, Furosemide, Glucose,
result. Guaiacol Glyceryl Ether, Hemoglobin, Imipramine, (+/-)-
LIMITATION OF THE TEST Ranitidine, Riboflavin, Sodium Chloride, Sulindac, Thioridazine,
1.Warning : A positive result with any of the tests indicates the pre- Trifluoperazine, Trimethobenzamide, Tyramine, Vitamin C.
intoxication. This immunological assay is qualitative; and provides BIBLIOGRAPHY
only a preliminary analytical test result. This result cannot be used 1.Baselt, R.C., Disposition of Toxic Drugs and Chemicals in Man.
for any legal consequence. A more specific alternative chemical Biomedical Publications, Davis, CA, (1982).
method like GC/MS (preferred confirmatory method) must be used in 2.Urine Testing for Drugs of Abuse, National Institute on Drug. Abuse
order to obtain a confirmed analytical result. Clinical consideration (NIDA), Research Monograph 73, (1986).
and professional judgment should be applied to any drug. 3.Fed. Register, Department of Health and Human Services,
2.If it is suspected that the samples have been tampered with, a new (1988), 53, 69,11970,.
specimen should be collected and the test should be repeated. If a cli- 4.Gorodetzkym, C. W., Detection of Drugs of Abuse in Biological
nician has some indication that the urine be adulterated, there are Fluids, (Martin WR eds: Drug Addiction I, New York, Spring - Verlag),
available test devices detecting the manipulation. (1977).
5.Hofmann F.E., A Handbook on Drug and Alcohol Abuse: The
3.There is a possibility that technical or procedural errors as well as Biomedical Aspects, (New York, Oxford University Press), 1983.
other substances and factors not listed may interfere with the test 6.Porter, W.H., Moyer, T.P., Clinical Toxicology. Tietz Fundamentals of
and cause wrong results. See SPECIFICITY. Clinical Chemistry, 5th Ed., Burtis, C.A. & Ashwood, E.R. (W.B.
PERFORMANCES 7.AGSA, Drugs of Abuse Testing Guidelines, www.consilia-
* Accuracy: sa.ch/agsa.
1. Sensitivity:
22 urines samples detected positive with GC/MS were all determined SYMBOLS USED ON THE LABELS:
positive with the test Rapidrog II-Morphine. The sensitivity of the test
Rapidrog II-Morphine compared to GC/MS is higher than 99%. Lot Number
2. Specificity: Consult instruction for use

49 urines samples detected negative with another immunological
technique of tracking (EMIT) were all determined negative with the In vitro diagnostic medical device
test Rapidrog II-Morphine. The specificity of the test Rapidrog II-
Morphine compared to EMIT method is higher than 99%. Manufacturer’s address
* Reproducibility: Temperature limitation

The reproducibility of the Rapidrog II-Morphine was evaluated on 3
different batches, by adding morphine in drug-free normal urines. All Expiration date
controls carried out are in conformity, and identical between them.
Do not reuse
* Specificity:
The specificity for the Rapidrog II-Morphine was tested by adding
various substances in drug-free normal human urines. The following (01/2004)
compounds produced positive results when tested at levels equal to or FTAN-RTMO-2
greater than the concentrations listed below:

RAPIDROG II
Multi 4
For in vitro diagnostic use only Ref.: RTDQ-0015 15 tests
CLINICAL SIGNIFICANCE It should be noted that the proportion amphetamine/metabolites

Use of narcotics became one of the social plagues the most destroy- depends on the urinary pH, the quantity of unchanged drug being
ing, affecting all the countries. According to the NIDA (National more significant with acid pH. The duration of detection in the urine
Institute of Drug Abuse), the drugs (addictive substances) the most is 48 hours; however it can reach 3 to 5 days according to urinary pH.
widespread are cannabinoids, opiates, cocaine and amphetamine
derivatives. Morphine (MOR) :
Cocaine (COC) : The term opiates (also called morphinie derivatives) gathers various
Cocaine or methylbenzoylecgonine is a natural alkaloid extracted natural or semi alkaloids synthetic derived from opium, resin extrac-
from the sheets of the Coka. It is a powerful stimulating Central ted from the soporific poppy (Papaver somniferum). Morphine is a
Nervous System (CNS), its sympathico-mimetic properties similar to powerful analgesic subjected to the regulation of the narcotics.
the action of the amphetamines make of it a dangerous drug. Its the- Codeine, codethyline and pholcodine (of semi-synthetic origin) and
rapeutic applications like local anaesthetic are renounced because of opium (officinal, dyeing, syrups) are used in many pharmaceutical
these addictive effects. This stimulation leads to a state of euphoria, preparations for their antitussives or antidiarrheic properties.
of physical and intellectual excitation, by a feeling of abolished tired- However therapeutic deviations exist. The heroin (or diacetylmor-
ness, self-confidence (effects known as "positive") and is accompanied phine) synthesized from morphine is only used at toxicomaniac ends.
by physical demonstrations such as dilation by the pupils, tremors, The action of opiates on the Central Nervous System (depressors of
fever and sweats. Its strong toxicity associated with the psychological the CNS) results in a state of euphoria, absence, anxiety, feeling to be
effects involves the appearance of the following symptoms: anxiety, well, but with strong amounts or of prolonged use, their toxicity
mental confusion, psychosis, convulsions and disorders cardiac. As results in various effects: reduction in coordination, absence of will,
for any addictive substance the tolerance with cocaine is significant respiratory depression, hypothermia and coma. The morphinic deri-
and induces the need for increasing the amounts to obtain the initial vatives tolerance is significant; it induces the need for increasing the
effect. The dependence which it involves is more psychic than physi- amounts to obtain the initial effect. The dependence is as well physi-
cal. Cocaine can either be smoked (cocaine bases or ace) or "sniff" (cut cal as psychic and results in a state of lack at the time of withdrawal.
hydrochlorate of cocaine) or injected by venous way (only or mixed The opiates have a complexe metabolism, whose morphine represents
with heroin), more rarely swallowed. The effects are intense but short. the "major structure". Indeed it is as well the main metabolite of the
The cocaine, whose half-life is half hour at one hour and half, is others derived as their "precursor". Heroin is quickly metabolized in
quickly metabolized by the liver mainly in benzoylecgonine, methyl morphine (half life of a few minutes). Codeine (methyl-3-morphine),
ecgonine ester and ecgonine. The norcocaine obtained by demethyla- codethyline (ethyl-3 morphine) and pholcodine are also transformed
tion appears only in the cases of acute intoxication (overdose). These into morphine. Morphine is metabolized on morphine-3-glucuronide
different me-tabolites are the mainly, which are excreted in the urine (70%) by the liver. Free or glucuronide morphine (morphine-3-glucu-
a few hours after the catch. The duration of detection of cocaine ronide) and codeine are the main urinary metabolites. The duration
(trace) in the urine is very short; on the other hand the time of reten- of detection of morphine and these metabolites in the urine is 1 to 2
tion of its metabolites in particular for the benzoylecgonine is 24 to 96 days.
hours. Cannabis (THC-∆9-Tetrahydrocannabinol-) :
Amphetamine (AMP) : The marijuana/cannabis (THC - ∆9-Tetrahydrocannabinol) is a hallu-
The amphetamine derivatives are powerful stimulants of the Cen-tral cinogen agent derived from the hemp (Cannabis sativa), mainly used
Nervous System (CNS), whose sympathomimetic properties are used by inhalation of smoke. Euphoria with low dose, marijuana produces
with amounts therapeutic for their appetite suppression and stimu- with higher amounts deterioration of sensory perceptions and moti-
lant action. With stronger amounts (therapeutic deviations, drug- lity, reduction in intellectual faculties, psychic disorders (depression
addiction), this stimulation produces effects known as "positive": and paranoia with very strong amount), increasing rate of heart. A
euphoria, intellectual promptness, physical excitation, feeling of abo- tolerance with the cardiac and psychotropic effects can occur. A pro-
lished tiredness and self-confidence, followed by other symptoms longed use can induce symptoms of lack (insomnia, anorexia and
(descent), anxiety, cardiac disturb, mental confusion, psychoses. nausea). The absorption speed varies according to the mode of admi-
In addition to amphetamine and metamphetamine, compounds such nistration.
as methylene-dioxyamphetamine (MDA) and 3,4-methylene-dioxyme- The THC is initially accumulated in the tissues (what explains the
tamphetamine (MDMA or "ECSTASY") also exist and are abused very long time of retention urinary), then metabolized by the liver in
Generally taken by oral way, nasal catch or by intravenous, the
amphetamines have a fast effect (2 to 4 hours after the catch). The various derivatives whose main component is the 11-nor-∆9-
amphetamine, whose it half life is 4 to 24 hours, is partially metabo- Tetrahydrocannabinol-9-carboxylic acid free or glucuronide excreted
lized by the liver (by oxidative desamination and hydroxylation). in the urine a few hours after the catch. The duration of detection
About 30% of amphetamine is excreted in the urine in unchanged varies according to several parameters; as an indication it can go 5
form. (Methamphetamine is metabolized in amphetamine, but 10 to days for an occasional smoker to more than 30 days for a chronic
20% is also excreted in unchanged form). So metabolites (benzoic smoker.
acid, hippurate…) and mother compounds are found in urines.
METHOD
Qualitative
1/4
(03/2004)
FTAN-RTDQ-3

RAPIDROG II
Multi 4
PRINCIPLE Specimen storage:

The Rapidrog II-Multi 4 is a rapid immunoassay for the qualitative The specimen may be refrigerated at 2-8°C for 2 days, or frozen at -
detection of four drugs (morphine, amphetamine, cannabis and 20°C for a longer period of time. Specimens that have been refrigera-
cocaine) and their metabolits in human urines. ted must be equilibrated to room temperature prior to testing.
The Rapidrog II-Multi-test 4 is an immunochromatographic test, in Specimens previously frozen must be thawed, equilibrated to room
which two different antigens compete for limited antibody. This prin- temperature, and mixed thoroughly prior to testing.
ciple is used to detect the four drugs (AMP, COC, THC and MOR).
PROVIDED MATERIAL
The membrane is pre-coated with each drug conjugate on the test The device consists in two reaction membranes inserted in a plastic
band (T) and colored mouse anti-drug monoclonal antibody-colloidal case. It is packaged in a sealed foil pouch also containing a dispos-
gold conjugate pad is placed at the right end. In the absence of the able sample dropper and a desiccant bag.
required drug in the urine, the conjugated anti-drug monoclonal-col-
loidal gold moves upward on the membrane chromatographically by
capillary action, to react with the immobilized drug conjugate zone (T) 1-MOR 3-COC
and generate a red line. Presence of the colored line indicates a nega-
tive result, while its absence indicates a positive result. 2-AMP 4-THC
When the required drug is present in the urine, it competes with the
antigen on the test band (T) for limited gold conjugate. When a suffi-
cient concentration of the required drug is present, it will fill the limi-
ted antibody binding sites. This will prevent attachment of the colored C- C -C -C Results area : Test (T)
antibody-colloidal gold conjugate to the drug conjugate zone on the 1- T -3 and Control (C)
test band region.
A control band with a different antigen/antibody reaction is also 2- -4
region (C) to indicate that the test has performed properly.
Cut-off :
Sample wells
The method of reference for the confirmation of the presence or the
absence of morphine, cocaine, THC, amphetamine (or/and their
metabolits) in the urines is Gas Chromatography coupled with the
Mass Spectrometry (GC/MS). This technique detects and quantifies in
a specific way:
-11-nor-∆9-Tetrahydrocannabinolcarboxilic acid and its derivates for TEST PROCEDURE
the cannabis 1. Allow test devices and urine sample to equilibrate to room tem-
- morphine and its derivates (codeine, codethyline…) perature (20-30°C) prior to testing. Do not open pouches until ready
- cocaine and its derivates (ecgonine, benzolecgonine…) to perform the assay to avoid condensation of moisture on the mem-
- d-amphetamine, l-amphetamine, metamphetamine brane.
The NIDA recommends cut-off concentration for GC/MS of 15 ng/ml 2. Removed the test device from foil pouch.
for THC, 150 ng/mL for benzolecgonine, 300 ng/mL for morphine and
500 ng/mL for amphetamine. 3. Holding the dropper vertically, dispense slowly 3 full drops of spe-
cimen (~ 120 µl) without air bubbles into each sample wells of the test
The cut-off concentrations of the test Rapidrog II-Multi 4 are: device. Take care that in both strips afterwards red color moves over
- THC (THC-carboxylic acid) 50 ng/ml the membrane. Use a separate pipette and device for each sample or
- MOR 300 ng/ml control (to avoid cross-contamination).
- COC (benzoylecgonine) 300 ng/ml
- AMP (d-amphetamine) 1000 ng/ml 4. Read the result after 5 minutes.
STORAGE AND STABILITY QUALITY CONTROL

The device stored at 2-30°C is stable until the expiration date state on The result is invalid if no line appears in the control region. Under no
the label. circumstances should a positive sample be identified until the control
line forms in the viewing area. If the control line does not form, the
test result is inconclusive and should be repeated.
SPECIMEN COLLECTION
Fresh urine does not require any special handling or pre-treatment.
Urine samples should be collected such that testing can be performed
as soon as possible after the specimen collection, preferably during
the same day.
Urine specimens and all materials coming in contact with them
should be handled and disposed of as if capable of transmitting infec-
tion. 2/4
(03/2004)
FTAN-RTDQ-3

RAPIDROG II
Multi 4
RESULTS: LIMITATION OF THE TEST

NEGATIVE TEST: 1.Warning : A positive result with any of the tests indicates the pre-
When a colored line appears in the area corresponding to one of the 4 sence of a drug/metabolite only, and does not indicate or measure
drugs (MOR, AMP, THC, and COC) or metabolites, the result is nega- intoxication. This immunological assay is qualitative; and provides
tive for this drug. only a preliminary analytical test result. This result can not be used
Note: The color intensity of the test lines can be different, but even if for any legal consequence. A more specific alternative chemical
the weak line appears the result should be interpreted such as a method like GC/MS (reference method) must be used in order to
negative test. obtain a confirmed analytical result. Clinical consideration and pro-
POSITIVE TEST:
In the absence of line in the area corresponding of one of the 4 drugs, 2.If it is suspected that the samples have been tampered with, a new
the result is positive for this drug. specimen should be collected and the test should be repeated. If a cli-
INVALID TEST:
In the absence of line in the control area (C), the test is invalid. It is 3.There is a possibility that technical or procedural errors as well as
recommended to repeat the test with a new test. other substances and factors not listed may interfere with the test
Examples:
PERFORMANCES
1-MOR 3-COC * Accuracy:
1-MOR 3-COC 1. Sensitivity:
2-AMP 4-THC 2-AMP 4-THC Urines samples detected positive with GC/MS were analysed with the
test Rapidrog II-Multi 4.
C- C -C -C Rapidrog II -Multi
GC/MS Sensitivity
C- C -C -C 4
1- T -3 COC 12 12 > 99 %
2- -4
1- T -3
AMP 10 10 > 99 %
2- -4
MOR 15 15 > 99 %
THC 29 29 > 99 %
2. Specificity:
Urines samples detected negative with GC/MS, HPLC or with an-
Invalid Test Valid Test other immunological technique of tracking (EMIT) were analysed with
the test Rapidrog II-Multi 4.
COC : (-)
THC : (-)
AMP : (-) Rapidrog
EMIT GC/MS HPLC Specificity
MOR : (-) II-Multi 4
21 21 > 99 %
COC -
22 21 > 95,4 %
1-MOR 3-COC 1-MOR 3-COC
2-AMP 4-THC 2-AMP 4-THC AMP - - 22 22 > 99 %
19 19 > 99 %
MOR -
20 20 > 99 %
8 8 > 99 %
THC -
C- C -C -C C- C -C -C 13 13 > 99 %
1- T -3 1- T -3
2- -4 2- -4
Valid Test Valid Test 3/4

COC : (+) COC : (+) (03/2004)
THC : (+) THC : (-) FTAN-RTDQ-3
AMP : (+) AMP : (+)
MOR : (+) MOR : (-)

RAPIDROG II
Multi 4
* Specificity: 6.Gorodetzkym, C. W., Detection of Drugs of Abuse in Biological

Cocaine : Fluids, (Martin WR eds: Drug Addiction I, New York, Spring - Verlag),
Benzoylecgonine 300 ng/mL (1977).
Cocaine 2000 ng/mL 7.Greenblatt, D.J., Shader, R.I., Benxodiazepines in Clinical Practice.
Ecgonine 20000 ng/mL (New York: Raven Press), (1974).
8.Harvey, R.A., Champe, P.C., Lippincotts Illustrated Reviews.
Amphetamine Pharmacology. 1992, (91-95).
d-amphetamine 1000 ng/mL 9.Hofmann F.E., A Handbook on Drug and Alcohol Abuse: The
l-amphetamine 20000 ng/mL Biomedical Aspects, (New York, Oxford University Press), 1983.
(+/-)3,4-methylene-dioxyamphetamine 1000 ng/mL 10.McBay, A. J., Clin. Chem. (1987), 33, 33.
Methylene-dioxymethamphetamine 10000 ng/mL 11.Porter, W.H., Moyer, T.P., Clinical Toxicology. Tietz Fundamen-tals
of Clinical Chemistry, 5th Ed., Burtis, C.A. & Ashwood, E.R. (W.B.
Morphine Saunders eds. Philadelphia USA), (2001), 636.
Morphine 300 ng/mL 12.Hammett-Stabler, C.A., Winecker, R., Ropero-Miller, J.D.,
Codeine 300 ng/mL Toxicology. Clinical Chemistry: Concepts and Application, Anderson,
Ethyl morphine 300 ng/mL S.C., Cockayne, S. (W.B. Saunders eds. Philadelphia USA), (1993),
Hydrocodone 500 ng/mL 1009.
Hydromorphone 500 ng/mL 13.AGSA, Drugs of Abuse Testing Guidelines, www.consilia-
Merperidine 30000 ng/mL sa.ch/agsa
Morphine-3-glucuronide 500 ng/mL
Oxycodone 15000 ng/mL SYMBOLS USED ON THE LABELS:
Thebaine 30000 ng/mL
6-Monoacetylmorphine 1000 ng/mL Lot Number
Oxymorphone 10000 ng/mL
Diacetyl morphine 1000 ng/mL Consult instruction for use
THC and derivates: In vitro diagnostic medical device

11-nor-∆8-THC-9-carboxylic acid 50 ng/mL
11-nor-∆9-THC-9-carboxylic acid 50 ng/mL
11-hydroxy-∆9-THC 20000 ng/mL Temperature limitation

∆8-THC 15000 ng/mL
Expiration date
∆9-THC 20000 ng/mL
Cannabinol 20000 ng/mL Do not reuse
Cannabidiol 100000 ng/mL
The following compounds produced negative results when tested at

100 µg/mL:
Acetone, Acetamidophen, Albumin, Amitriptyline, Ampicillin, As-par-
tame, Aspirin, Atropine, Benzocaine, Bilirubin, Caffeine, Chloro-
quine, (+/-)-Chlorpheniramine, Chlorpheniramine, Crea-tine,
Dexbrompheniramine, Dextromethorphan, Dopamine, 4-
Dimethylaminoantipyrine, Erythromycin, Ethanol, Furosemide,
Glucose, Guaiacol Glyceryl Ether, Hemoglobin, Imipramine, (+/-)-
BIBLIOGRAPHY
1.Baselt, R.C., Disposition of Toxic Drugs and Chemicals in Man.
Biomedical Publications, Davis, CA, (1982).
2.Urine Testing for Drugs of Abuse, National Institute on Drug. Abuse
3.Ellenhorn, M.J., Barceloux, D.G., Medical Toxicology. (Elsevier
Science Publishing Company, Inc., New York), (1988).
Mandatory Guidelines for Federal Workplace Drug Testing Pro-grams,
(1988), 53, 69,11970,.
5.Gilman, A. G., Goodman, L. S., The Pharmacological Basis of 4/4
Therapeutics, (MacMillan Publishing eds., New York, NY), (1980). (03/2004)
FTAN-RTDQ-3

RAPIDROG II
THC
For in vitro diagnostic use only Ref.: RTTH-0015 15 tests

The marijuana/cannabis (THC -∆9-Tetrahydrocannabinol) is a hallu- The device stored at 2-30°C is stable until the expiration date state on
cinogen agent derived from the hemp (Cannabis sativa), mainly used the label.
by inhalation of smoke. Euphoria with low dose, marijuana produces
with higher amounts deterioration of sensory perceptions and moti- SPECIMEN COLLECTION
lity, reduction in intellectual faculties, psychic disorders (depression Fresh urine does not require any special handling or pre-treatment.
and paranoia with very strong amount), increasing rate of heart. A Urine samples should be collected such that testing can be per-for-
tolerance with the cardiac and psychotropic effects can occur. A pro- med as soon as possible after the specimen collection, preferably
longed use can induce symptoms of lack (insomnia, anorexia and during the same day.
nausea). The absorption speed varies according to the mode of admi- Urine specimens and all materials coming in contact with them
nistration. should be handled and disposed of as if capable of transmitting infec-
The THC is initially accumulated in the tissues (what explains the tion.
very long time of retention urinary), then metabolized by the liver in Specimen storage:
The specimen may be refrigerated at 2-8°C for 2 days, or frozen at
various derivatives whose main component is the 11-nor-∆9-
-20°C for a longer period of time. Specimens that have been refrig-era-
Tetrahydrocannabinol-9-carboxylic acid free or glu-curonide excreted
ted must be equilibrated to room temperature prior to testing.
in the urine a few hours after the catch. The duration of detection
Specimens previously frozen must be thawed, equilibrated to room
varies according to several parameters; as an indication it can go 5
temperature, and mixed thoroughly prior to testing.
days for an occasional smoker to more than 30 days for a chronic
smoker.
PROVIDED MATERIAL
The device consists in a reaction membrane inserted in a plastic case.
METHOD
It is packaged in a sealed foil pouch also containing a dispos-able
sample dropper and a desiccant bag.
Qualitative
Result area
PRINCIPLE Control (C) Test (T) Sample well
The Rapidrog II-THC is a rapid immunoassay for the qualitative detec-
tion of 11-nor-∆9-Tetrahydrocannabinol-9-carboxilic acid in human
urine at a cut-off concentration of 50 ng/mL, before con-firmation
with a reference method. The membrane is pre-coated with drug C T
conjugate on the test band (T) and a colored mouse anti-THC mono-
clonal antibody-colloidal gold conjugate pad is placed at the right end.
In the absence of drug in the urine, the conjugated anti-THC mono-
clonal-colloidal gold moves upward on the membrane chromatogra-
phically by capillary action, to react with the immobilized drug conju-
gate zone (T) and generate a red line. Pres-ence of the colored line
indicates a negative result, while its ab-sence indicates a positive TEST PROCEDURE
result. 1. Allow test devices and urine sample to equilibrate to room tem-
When the drug is present in the urine, it competes with the antigen perature (20-30°C) prior to testing. Do not open pouches until ready
on the test band (T) for limited gold conjugate. When a sufficient to perform the assay.
concentration of drug is present, it will fill the limited antibody bin-
ding sites. This will prevent attachment of the colored antibody-colloi- 2. Remove the test device from foil pouch (bring the device to room
dal gold conjugate to the drug conjugate zone on the test band region. temperature before opening the pouch to avoid condensation of mois-
A control band with a different antigen/antibody reaction is also ture on the membrane).
region (C) to indicate that the test has performed properly. 3. Holding the dropper vertically, dispense 3 full drops of specimen (~
120 µl) without air bubbles into the sample well of the test device. Use
Cut-off : a separate pipette and device for each sample or control (to avoid
- The cut-off concentration of the test Rapidrog II-THC is 50 ng/mL. cross-contamination).
- The method of reference for the confirmation of the presence or the
absence of cannabis derivates in the urines is Gas Chromatog-raphy 4. Read result between 3 to 8 minutes after the addition of sample.
coupled with the Mass Spectrometry (GC/MS). This tech-nique Do not read result after 8 minutes.
detects and quantifies in a specific way 11-nor-∆9-THC-9-carboxilic
acid free or glucuronide. NIDA (National Institute on Drug Abuse)
recommends cut-off concentration of 15 ng/mL for THC-carboxilic
acid for GC/MS.
…/…
(01/2004)
FTAN-RTTH-3

RAPIDROG II
THC
QUALITY CONTROL 11-nor-∆8-THC-9-carboxylic acid 50 ng/mL

The result is invalid if no line appears in the control region. Under no 11-nor-∆9-THC-9-carboxylic acid 50 ng/mL
circumstances should a positive sample be identified until the control
line forms in the viewing area. If the control line does not form, the 11-hydroxy-∆9-THC 20000 ng/mL
test result is inconclusive and the test should be repeated. ∆9-THC 15000 ng/mL
Good laboratories practice recommends the use of control materials ∆9-THC 20000 ng/mL
Cannabinol 20000 ng/mL
Cannabidiol 100000 ng/mL
RESULTS
result is NEGATIVE. Intensity of lines could be Acetone, Acetamidophen, Albumin, Amitriptyline, Ampicillin, As-par-
different, and even if the line in the test region tame, Aspirin, Atropine, Benzocaine, Bilirubin, Caffeine, Chloro-
(T) is very weak, the result must be interpreted quine, (+/-)-Chlorpheniramine, Chlorpheniramine, Creatine,
such as negative. Dexbrompheniramine, Dextromethorphan, 4-
Dimethylaminoantipyrine, Dopamine, Erythromycin, Ethanol,
2. If only one colored line appears in the C T Furosemide, Glucose, Guaiacol Glyceryl Ether, Hemoglobin,
control region (C), the result is POSITIVE. Imipramine, (+/-)-Isoproterenol, Lidocaine, (+)-Naproxen, Oxalic Acid,
The absence of a test line indicates a positive Penicillin-G, Pheniramine, Phenothiazine, Phenylethylamine,
result. Procaine, Quinidine, Ranitidine, Riboflavin, Sodium Chloride,
Sulindac, Thioridazine, Trifluoperazine, Trimethobenzamide,
LIMITATION OF THE TEST Tyramine, Vitamin C.
sence of a drug/metabolite only, and does not indicate or meas-ure BIBLIOGRAPHY
intoxication. This immunological assay is qualitative; and provides 1.Baselt, R.C., Disposition of Toxic Drugs and Chemicals in Man.
only a preliminary analytical test result. This result cannot be used Biomedical Publications, Davis, CA, (1982).
for any legal consequence. A more specific alternative chemical 2.Urine Testing for Drugs of Abuse, National Institute on Drug. Abuse
method like GC/MS (preferred confirmatory method) must be used in (NIDA), Research Monograph 73, (1986).
order to obtain a confirmed analytical result. Clinical consideration 3.Fed. Register, Department of Health and Human Services, Man-
and professional judgment should be applied to any drug. datory Guidelines for Federal Workplace Drug Testing Programs,
(1988), 53, 69,11970,.
2.If it is suspected that the samples have been tampered with, a new 4.McBay, A.J., Clin. Chem. (1987), 33, 33B-40B.
specimen should be collected and the test should be repeated. If a cli- 5.Gilman, A. G., Goodman, L. S., The Pharmacological Basis of
nician has some indication that the urine be adulterated, there are Therapeutics, (MacMillan Publishing eds., New York, NY), (1980).
available test devices detecting the manipulation. 6.Porter, W.H., Moyer, T.P., Clinical Toxicology. Tietz Fundamentals of
3.There is a possibility that technical or procedural errors as well as Saunders eds. Philadelphia USA), (2001), 636.
other substances and factors not listed may interfere with the test 7.Hammett-Stabler, C.A., Winecker, R., Ropero-Miller, J.D., Toxi-
and cause wrong results. See SPECIFICITY. cology. Clinical Chemistry: Concepts and Application, Anderson, S.C.,
Cockayne, S. (W.B. Saunders eds. Philadelphia USA), (1993), 1009.
PERFORMANCES 8.AGSA, Drugs of Abuse Testing Guidelines, www.consilia-sa.ch/agsa
* Accuracy:
1. Sensitivity: SYMBOLS USED ON THE LABELS:
48 urines samples detected positive with GC/MS were all deter-mined
positive with the test Rapidrog II-THC. The sensitivity of the test Lot Number
Rapidrog II-THC compared to GC/MS is higher than 99%.
2. Specificity:
19 urines samples detected negative with another immunological In vitro diagnostic medical device
technique of tracking (EMIT) were all determined negative with the
test Rapidrog II-THC. The specificity of the test Rapidrog II-THC com- Manufacturer’s address
pared to EMIT method is higher than 99%.
* Reproducibility:
The reproducibility of the Rapidrog II-THC was evaluated on 3 diffe- Expiration date
rent batches, by adding 11-nor-∆9-Tetrahydrocannabinol-9-carboxi-
lic acid in drug-free normal urines. All controls carried out are in Do not reuse
conformity, and identical between them.
* Specificity:
The specificity for the Rapidrog II -THC was tested by adding vari-ous (01/2004)
substances in drug-free normal human urines. FTAN-RTTH-3
The following compounds produced positive results when tested at
levels equal to or greater than the concentrations listed below:

OTHER REAGENTS
PMR TEST
AMNICATOR®
Premature Membranes Rupture test
Réf. : PMRT - 0010 10 tests


PROCEDURE
In a normal birth the foetal membranes (chorionic and amnio- 1- Clean the vulva and vaginal orifice to avoid contamination
tic) rupture during labour. In 3 -17 % of pregnancies, however, that could interfere with the test.
the membranes rupture spontaneously before labour begins, a 2 - Insert a speculum into the vagina and sample exposing the
process known as premature rupture of the membranes. Its cervix.
frequency varies according to the term, the more premature 3 - Remove the swab from its protective packaging, ensuring
the labour, the greater the frequency. Premature Rupture of the the tip does not touch anything.
Membranes is observed in 25 to 40 % in the premature labours. 4 - Pass the PMR test into the vagina and sample for 5 seconds
The main factors are mechanical (Multiple pregnancies, poly- any liquid present at the external cervical os, or in the poste-
hydramnios) and infections. rior fornix of the vagina or around the cervical orifice, but
Others factors : never introduce into the cervix.
- Patients at high risk of premature labour 5 - Withdraw the PMR test.
- Antepartum haemmorrhage 6 - Observe the colour of the swab bud after 5 seconds.
- Aged primipara Disregard any colour change which occurs after 30 seconds.
- Vitamin deficiency 7 - Compare the colour with the colour chart below
- Heavy smoking
READING RESULTS/EXPECTED VALUES
Risks associated with Premature Rupture membranes are a
high foetal mortality and morbidity. It is thus important to
have a reliable diagnostic test in order to set up appropriate
medical follow-up.
METHOD
Qualitative and colorimetric
PRINCIPLE 7-9 ( )
PMR test Amnicator is an easy and rapid detection of Prema-

ture Ruptured foetal Membrane (PMR) during pregnancy.
This qualitative test detects the change in vaginal pH using a
sterile swab impregnated with Nitrazine yellow. Intact Ruptured
The pH within the vagina in women during pregnancy would membranes membranes
normally be between 5.2 and 6 whereas the pH of amniotic
fluid is generally between 7.1 and 7.2. Intact membranes Ruptured membranes
The seepage of amniotic fluid which passes from uterus to the
pH 5.0 Yellow pH 6.5 Olive green
vagina causes an increase in the pH of fluid which is revealed
by colour of the swab bud changing from yellow to deep blue. pH 5.5 Yellow pH 7.0 Blue
pH 6.0 Yellow/Pale green pH 7.5 Deep blue
REAGENTS AND MATERIAL PROVIDED
PMR test is a sterile device packaged in an individual plastic
pouch. PERFORMANCE DATA (1)
It does not contain latex. A clinical study was performed on 114 samples of vaginal
secretions provided by 104 patients.
MATERIAL NOT PROVIDED The PMR test was compared with the clinical diagnosis and
Speculum DAO method (Enzymatic activity of DiAmine Oxidase present
at high concentration in amniotic liquid).
PRECAUTIONS The sensitivity of PMR test is significantly superior to that
1- Read carefully the insert before proceeding to the analysis. obtained with DAO quantitative method.
2- Do not use the test if the packaging is damaged.
3- Do not use tests which have been badly stored. Amnicator DAO
4- Respect the expiry date. Sensitivity (%) 97.50 90.20
5- After use, dispose of test material in accordance with local Specificity (%) 93.30 96.60
regulations for potentially infectious materials.
These results were compared to others studies in the litera-
STORAGE AND STABILITY ture :
When stored at the room temperature and protected from light .../...
the devices are stable until the expiry date stated on the label.
(03/2005)
FTAN-PMRT-6
Medical Wire & Equipment, Corsham, Wiltshire, SN13 9RT, UK 151

PMR TEST
AMNICATOR®
Premature Membranes Rupture test
1- Methods of pH BIBLIOGRAPHY
Samples Sensitivity Specificity “Reliability”
1. Filet, J.P. et coll., Evaluation de trois méthodes diagnosti-
number (%) (%) (%)
ques dans la rupture prématurée des membranes. Rev. Fr.
Reference (1) 104 97.50 93.30 93.80 Gynecol. Obstet., (1994), 89, 123.
2. Gillibrand, P.N., Premature rupture of the membranes and
Reference (7) 39 100 92.30 -
prematurity. J. Obstet. Gynaecol. Br. Commonw., (1967), 74,
Reference (8) 100 95 93.70 90.30 678.
Reference (9) 45 91 73 - 3. Drife, J.O., Preterm rupture of the membranes. Br. Med. J.,
(1982), 285, 583.
4. Pauersterin, C., Premature rupture of the membranes.
1- Methods DAO : Clinical Obstetrics, John Wiley & Sons and Churchill
Livingstone, (1987), 367.
Samples “Reliability” Sensitivity 5. Pritchard, J., MacDonald, P., Williams Obstetrics, 16ème
Etudes ed., Appleton-Century-Crofts, (1980), 407.
number (%) (%)
6. Berland, M., Magnin, G., La rupture prématurée des mem-
Reference (1) 104 20 µU/ml 92.10 90.20 branes. Encycl.Méd.Chir., (Paris), (1982), Obst., 5072 B10, 5.
Study A 272 70 UI/ml 95.80 91.40 7. Mills, A.M., Garrioch, D.B., Use of Nitrazine yellow swab test
in the diagnosis of rupture membrane, Br. J. Obstet. Gynaecol.,
Study B - - 91 - (1977), 84, 138.
Study C - - 96 - 8. Friedman, M.L., MacElin, T.W., Diagnosis of ruptured fetal
membranes. Clinical study and review of literature. Am.J.
Study D - - 99 - Obstet Gynecol., 1969, 104, 544.
Study E 160 25 U/Bdl 87.40 - 9. Garite T., Gocke S. Diagnosis of preterm rupture of membra-
nes : is testing for alpha fetoprotein better than ferning or nitra-
zine ? Am. J. Perinatol., (1990), 7, 276.
LIMITATIONS (3,7,8)
PMR test is based on measurement of pH, and the presence of

vaginal contaminants can lead to false results.
0088
pH could be artificially increased or decreased which could
lead to false positive or false negative results, for example as a
result of SYMBOLS USED ON THE LABELS :
- Vaginal infection (Trichomonas Vaginalis or cocci gram +)
(pH> 7) Lot number
- Antibiotics (increasing of vaginal pH).
Consult instructions for use
- Presence of sperm (pH between 7.3-7.5).
- Contaminations with alkaline urine. Manufacture’s adress
- Excessive use of soap or local antiseptics with alkaline pH,
except gynaecologic creams or liquid used moderately. Expiration date
- Presence of blood
- Prolonged rupture. Temperature limitation
Avoid exposure to direct sunlight
Do not reuse
Method of stérilization using irradiation
(03/2005)
FTAN-PMRT-6
Medical Wire & Equipment, Corsham, Wiltshire, SN13 9RT, UK 152

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DIAGNOSTIC

Update ALBUMIN . . . . . . . . . . . . . . . . . . . . . . . . ALBU-4 . . . . . 13-14

CK-MB . . . . . . . . . . . . . . . . . . . . . . . . . . CKMB-3 . . . . . 44-45

CONTROLS AND CALIBRATORS

ELISTRIP Urinary strip this technical insert is available on request

To get optimal performances, ELITECH advises you to follow closely

ELITECH is tuned in to you for all requests and techni-

For in vitro diagnostic use only Ref.: PACI - 0030 18 x 3 mL

METHOD Note : Development of particles could appears in the rea-

PRINCIPLE WR 2 : Dissolve the reagent 2 in 5 mL of distilled water.

STABILITY OF REAGENTS Total Non-Prostatic

PREPARATION AND STABILITY WR 2 - 10 µL

SEPPIM S.A Zone Industrielle 61500 SEES FRANCE 11

Haemoglobin : Negative bias from 50 µmol/L for

- Precision Consult instruction for use

): Important modification from the previous version

SEPPIM S.A Zone Industrielle 61500 SEES FRANCE 12

Ref.: ALBU - 0600 2 x 125 mL

CLINICAL SIGNIFICANCE (1-5) PREPARATION AND STABILITY

SEPPIM S.A Zone Industrielle 61500 SEES FRANCE 13

QUALITY CONTROL Haemoglobin : No significant interference up to 500 mg/dL

Ascorbic acid : No significant interference up to

): Important modification from the previous version

SEPPIM S.A Zone Industrielle 61500 SEES FRANCE 14

Ref.: ALSL - 0410 2 x 62.5 mL

CLINICAL SIGNIFICANCE (1-4) STABILITY OF REAGENTS

SEPPIM S.A Zone Industrielle 61500 SEES FRANCE 15

CALCULATION - Interferences (6,7)

): Important modification from the previous version

SEPPIM S.A Zone Industrielle 61500 SEES FRANCE 16

Ref : ALAT - 0030 20 x 3 mL

STABILITY OF REAGENTS LINEARITY

REFERENCE VALUES Manufacturer’ s address

Note : It is recommended for each laboratory to establish and

): Important modification from the previous version

SEPPIM S.A Zone Industrielle 61500 SEES FRANCE 17

Ref : AMSL - 0390 1 x 50 mL

CNP = 2-Chloro-4-nitrophenol Read against distilled water.

REFERENCE VALUES BIBLIOGRAPHY

): Important modification from the previous version

SEPPIM S.A Zone Industrielle 61500 SEES FRANCE 18

For in vitro diagnostic use only Ref : AMYL - 0030 20 x 3 mL

PRINCIPLE Note : It is recommended for each laboratory to establish and

Reagent 2 : R2 Working reagent : 1 mL

): Important modification from the previous version

SEPPIM S.A Zone Industrielle 61500 SEES FRANCE 19

Ref.: ASSL - 0410 2 x 62.5 mL

CLINICAL SIGNIFICANCE (1-4) STABILITY OF REAGENTS

Serum, plasma (37°C): < 40 U/L

Reagent 2: R2 Mix and after a 50 second incubation, measure the change of

SEPPIM S.A Zone Industrielle 61500 SEES FRANCE 20

CALCULATION - Interferences (6,7)

Temperature limitation (01/2005)

): Important modification from the previous version

SEPPIM S.A Zone Industrielle 61500 SEES FRANCE 21

Ref : ASAT - 0030 20 x 3 mL

Read against distilled water.

REFERENCE VALUES Temperature limitation

Without pyridoxal-5-phosphate Expiration date

Note : It is recommended for each laboratory to establish and

): Important modification from the previous version

SEPPIM S.A Zone Industrielle 61500 SEES FRANCE 22

Ref : BILI - 0600 TOTAL 125 mL