Documente Academic
Documente Profesional
Documente Cultură
REF 1100005
4 x 10 mL ACID PHOSPHATASE
CONTENTS
TOTAL AND PROSTATIC
R1.Reagent 1 x 40 mL
R2. Reagent 1 x 20 mL Colorimetric method
R3. Reagent 4 x 10 mL
KINETIC
R4. Reagent 1 x 3 mL
OPTIMIZED
For in vitro diagnostic use only
PRINCIPLE
The method is based on the hydrolysis of α-naphtyl phosphate
1,2
Specimens not preserved in this manner are unsuitable for analysis.
at pH 5.0 by acid phosphatase (ACP) to produce α-naphtol and ACP activity in preserved serum is stable for 4-5 days at 2-8ºC.
inorganic phosphate. The pentanediol acts as a phosphate
acceptor increasing the reaction sensitivity. INTERFERENCES
The α-naphtol reacts with Fast Red TR , to produce a coloured
*
complex directly proportional to the activity of the ACP in the − Lipemia (intralipid >1,25 g/L) may affect the results.
sample. − Bilirubin (>1,25 g/L) may affect the results.
ACP
− Hemoglobin may affect the results.
α-Naphtyl phosphate + H2O α-Naphtol + Pi
− Other drugs and substances may interfere .
5-6
pH 5,0
α-Naphtol + Fast Red TR Azo dye MATERIALS REQUIRED
30-37ºC
* Diazotized 2- Amino-5-chlorotoluene − Photometer or spectrophotometer with a thermostatted cell
compartment set at 30/37ºC, capable of reading at 405 nm.
The sample tested in the presence of L-tartrate inhibits the − Stopwatch, strip-chart recorder or printer.
prostatic acid phosphatase of the total ACP activity. − Cuvettes with 1-cm pathlength.
− Pipettes to measure reagent and samples.
REAGENT COMPOSITION
PROCEDURE
R1 Citrate buffer. Sodium citrate 110 mmol/L, 1,5-pentanediol
220 mmol/L, pH 5.2.
1. Preincubate working reagent, samples and controls to reaction
R2 Citrate/Tartrate buffer. Sodium citrate 110 mmol/L, 1,5- temperature.
pentanediol 220 mmol/L, L-tartrate 110 mmol/L, pH 5.2. 2. Set the photometer to 0 absorbance with distilled water.
3. For Total acid and/or Non-Prostatic acid tests pipette into
R3 ACP sustrate. Powder. α-Naphtyl phosphate 12.5 labelled cuvettes:
mmol/L, Fast Red TR 1.25 mmol/L, after reconstitution.
QUALITY SYSTEM CERTIFIED LINEAR CHEMICALS S.L. Joaquim Costa 18 2ª planta. 08390 Montgat, Barcelona, SPAIN
ISO 9001 ISO 13485 Telf. (+34) 934 694 990 Fax. (+34) 934 693 435. website www.linear.es
REFERENCE VALUES 4 NOTES
Serum
1. This method may be used with different instruments. Any
application to an instrument should be validated to demonstrate
Reaction temperature 37ºC 30ºC
that results meets the performance characteristics of the
method. It is recommended to validate periodically the
Total ACP, up to 6.6 U/L (110 nkat/L) 7.0 U/L (278 nkat/L) instrument. Contact to the distributor for any question on the
application method.
Prostatic ACP, up to 3.5 U/L (108 nkat/L) 2.6 U/L (43 nkat/L)
2. Clinical diagnosis should not be made on findings of a single test
result, but should integrate both clinical and laboratory data.
It is recommended that each laboratory establishes its own
reference range.
REFERENCES
QUALITY CONTROL
1. Hillmann, G.V. Clin. Chem. Biochem. 9 : 273 (1971).
To ensure adequate quality control (QC), each run should include a 2. Fabiny-Byrd, DL y Ertinghausen. Clin.Chem 13:841 (1972).
set of controls (normal and abnormal) with assayed values handled 3. Young, D.S., Pestaner, L.D. and Gibberman, V. Clin Chem.
as unknowns. 21, Vol. 5, 10-432D (1975).
rd
4. Junge, W. et al. Pecs, Hongrie: 3 Alpe-Adria Congress on
REF 1980005 HUMAN MULTISERA NORMAL Clinical Chemistry and Laboratory Medicine, 7-9 Septembre
Borderline level of ACP. Assayed. 1994.
5. Young DS. Effects of drugs on clinical laboratory tests, 4th
REF 1985005 HUMAN MULTISERA ABNORMAL ed. AACC Press, 1995.
Elevated level of ACP. Assayed. 6. Tietz. N.W. Textbook of Clinical Chemistry, 2th Edition. Burtis
CA, Ashwood ER. W.B. Saunders Co. 1994.
If the values are found outside of the defined range, check the
instrument, reagents and procedure.
Each laboratory should establish its own Quality Control scheme
and corrective actions if controls do not meet the acceptable
tolerances.
CLINICAL SIGNIFICANCE
ANALYTICAL PERFORMANCE
QUALITY SYSTEM CERTIFIED LINEAR CHEMICALS S.L. Joaquim Costa 18 2ª planta. 08390 Montgat, Barcelona, SPAIN
ISO 9001 ISO 13485 Telf. (+34) 934 694 990 Fax. (+34) 934 693 435. website www.linear.es