Documente Academic
Documente Profesional
Documente Cultură
AST/GOT 4+1 SL
References :
Kit composition :
ASSL-0250
ASSL-0455
Conversion factor:
8 x 25 mL
4 x 55 mL
R1: 8 x 20 mL
R1: 4 x 44 mL
+
+
R2: 8 x 5 mL
R2: 4 x 11 mL
PROCEDURE
See application included in the barcode indicated at the end of the insert.
INTENDED USE
ELITech Clinical Systems AST/GOT 4+1 L is intended for use in the quantitative in vitro diagnostic determination of
aspartate aminotransferase (AST) in human serum and plasma on ELITech Clinical Systems Selectra Pro Series
Analyzers. Aspartate aminotransferase (AST) measurements are used in the diagnosis and treatment of certain
types of liver and heart diseases.
It is not intended for use in Point of Care settings*.
CALIBRATION
For calibration, multiparametric calibrator Elical 2 must be used. Its value is traceable to IFCC reference method (5).
Calibration frequency: refer to PERFORMANCE DATA.
QUALITY CONTROL
METHOD (5)
IFCC method without pyridoxal phosphate (P-5-P).
Kinetic. UV.
To ensure adequate quality, control sera such as ELITROL I (normal control) and ELITROL II (abnormal control)
should be used. These controls should be assayed together with patient samples, at least once a day and after
each calibration.The control frequency should be adapted to Quality Control procedures of each laboratory and the
regulatory requirements. Results should be within the defined ranges. If values fall outside of the defined ranges,
each laboratory should take corrective measures. Quality control materials should be used in accordance with
local, state, and/or federal guidelines.
PRINCIPLE (5)
Kinetic determination of aspartate aminotransferase (AST) activity :
AST
L-Aspartate + -Ketoglutarate
Oxaloacetate + L-Glutamate
MDH
Oxaloacetate + NADH + H+
L-Malate + NAD+
- Precision
Determined according to CLSI(9) EP5-A2 protocol.
REAGENTS COMPOSITION
Reagent 1 : R1
Tris buffer, pH 7.80 (30C)
L-Aspartate
Lactate dehydrogenase (LDH) (microorganisms)
Malate dehydrogenase (MDH) (bacterial)
Sodium azide
Reagent 2 : R2
-Ketoglutarate
NADH
Sodium azide
Mean
<
100 mmol/L
330 mmol/L
2000
U/L
1000
U/L
0.1
%
<
78 mmol/L
1.1 mmol/L
0.1
%
Low level
ref.CALI-0580,
ref.CONT-0080,
ref.CONT-0180,
U/L
kat/L
40
21.0
54.1
201.0
0.35
0.90
3.35
Medium level 40
High level
40
Total
CV (%)
1.6
0.6
0.2
2.1
1.5
1.4
- Correlation
A comparative study has been performed between an ELITech Clinical Systems Selectra ProM Analyzer and another FDA-Approved system equipment (IFCC method without pyridoxal phosphate) on 100 human serum samples
according to CLSI(10) EP9-A2 protocol.
The sample concentrations were between 9.9 and 248.1 U/L (0.17 and 4.14 kat/L).
The parameters of the linear regressions are as follows :
Correlation coefficient: (r) =0.999
Linear regression:
y = 1.029 x - 0.2 U/L
Within-run
4 x 3 mL.
10 x 5 mL.
10 x 5 mL.
- Interferences
Studies have been performed to determine the level of interference from different compounds according to CLSI(11)
EP7-A2 protocol and SFBC recommendations(12). Recovery within 10% of initial value at AST activity of 50 U/L
and 200 U/L.
Unconjugated Bilirubin:
No significant interference up to 30 mg/dL (513 mol/L).
Conjugated Bilirubin:
No significant interference up to 29.5 mg/dL (504 mol/L).
Turbidity:
No significant interference up to 614 mg/dL (6.94 mmol/L) Triglyceride equiva-lent.
Ascorbic acid:
No significant interference up to 20 mg/dL (1136 mol/L).
Pyruvate:
No significant interference up to 3 mg/dL (340 mol/L).
WASTE MANAGEMENT
Disposal of all waste material should be in accordance with local, state and Federal regulatory requirements.
STABILITY OF REAGENTS
In very rare cases, monoclonal gammopathies (multiple myeloma), in particular IgM type (Waldenstroms macroglobulinemia) can cause unreliable results.(13)
Other compounds may interfere.(14,15)
Note : Hemolyzed samples should not be used since significant hemolysis may increase AST concentration because
of high levels of AST in erythrocytes.
PREPARATION
SAMPLES (2, 6)
REAGENT DETERIORATION
- Specimen
Serum free from hemolysis.
Lithium heparinized plasma, free from hemolysis.
- Storage
Samples are stable 24 hours at room temperature, 7 days at 2-8C and 3 months at -20C.
- Measuring range
Determined according to CLSI(7) EP6-A protocol, the measuring range is from 10.0 to 250.0 U/L (0.17 to 4.17
kat/L). Samples exceeding 250.0 U/L should be diluted 1:10 with NaCl 9 g/L solution (normal saline) and reassayed. Use of this procedure extends the measuring range to 250.0 to 2500.0 U/L (4.17 to 41.67 kat/L). This
extended measuring range was confirmed in a study where a high activity of AST was spiked into native serum
samples. The recovery observed did not exceed the expected recovery by > 10%.
(03/2016)
FTNA-ASSL-v5
* : US FDA only
.../...
AST/GOT 4+1 SL
References :
ASSL-0250
ASSL-0455
Kit composition :
8 x 25 mL
4 x 55 mL
R1: 8 x 20 mL
R1: 4 x 44 mL
+
+
R2: 8 x 5 mL
R2: 4 x 11 mL
Within-run
U/L
kat/L
Total
CV (%)
Low level
80
18.8
0.31
2.9
4.3
Medium level
80
43.3
0.72
1.4
1.9
High level
80
197.5
3.29
0.7
1.6
- Correlation
A comparative study has been performed between an ELITech Clinical Systems Selectra ProS Analyzer and another FDA-Approved system equipment (IFCC method without pyridoxal phosphate) on 100 human serum samples
according to CLSI(10) EP9-A2 protocol.
The sample concentrations were between 10.5 and 244.2 U/L (0.18 and 4.08 kat/L).
The parameters of the linear regressions are as follows :
Correlation coefficient: (r) =1.000
Linear regression:
y = 0.999 x + 0.6 U/L (0.01 kat/L)
- Interferences
Studies have been performed to determine the level of interference from different compounds according to CLSI(11)
EP7-A2 protocol and SFBC recommendations(12). Recovery within 10% of initial value at AST activity of 50 U/L
and 200 U/L.
Unconjugated Bilirubin: No significant interference up to 30 mg/dL (513 mol/L).
Conjugated Bilirubin:
No significant interference up to 29.5 mg/dL (504 mol/L).
Turbidity:
No significant interference up to 614 mg/dL (6.94 mmol/L) Triglyceride equivalent.
Ascorbic acid:
No significant interference up to 20 mg/dL (1136 mol/L).
Pyruvate:
No significant interference up to 3 mg/dL (340 mol/L).
In very rare cases, monoclonal gammopathies (multiple myeloma), in particular IgM type (Waldenstroms macroglobulinemia) can cause unreliable results.(13)
Other compounds may interfere.(14,15)
Note : Hemolyzed samples should not be used since significant hemolysis may increase AST concentration because
of high levels of AST in erythrocytes.
- On board stability/Calibration frequency
On Board Stability : 28 days
Calibration frequency : 28 days
Recalibrate when reagent lots change, when quality control results fall outside the established range, and after
a maintenance operation.
BIBLIOGRAPHY
1. Henderson, A.R., Moss, D.W., Enzymes, Tietz Fundamentals of Clinical Chemistry, 5th Ed., Burtis, C.A. &
Ashwood, E.R. (W.B. Saunders eds. Philadelphia USA), (2001), 352.
2. Tietz, N.W., Clinical guide to laboratory tests, 3rd Ed., (W.B. Saunders eds. Philadelphia USA), (1995), 76.
3. Scherwin, J.E, Liver function. Clinical Chemistry : Theory, Analysis, Correlation, 4th Ed., Kaplan, L.A, Pesce, A.J.,
Kazmierczak, S.C., (Mosby Inc. eds St Louis USA), (2003), 492 and appendix.
4. Ward, M.K., Cockayne, S., Enzymology. Clinical Chemistry : Concepts and Application, Anderson, S.C.,
Cockayne, S. (W.B. Saunders eds. Philadelphia USA), (1993), 238.
5. Schumann, G., et al. Clin Chem Lab Med., (2002), 40, 725.
6. Guder, W.G., et al., Use of anticoagulants in diagnostic laboratory investigations and stability of blood, plasma
and serum samples. (2002). WHO/DIL/LAB/99.1 Rev.2.
7. Evaluation of the Linearity of the Measurement of Quantitative Procedures: a Statistical Approach; Approved
Guideline. CLSI (NCCLS) document EP6-A (2003), 23 (16).
8. Protocols for Determination of Limits of Detection and Limits of Quantification; Approved Guideline. CLSI
(NCCLS) document EP17-A (2004), 24 (34).
9. Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline - Second
Edition. CLSI (NCCLS) document EP5-A2 (2004), 24 (25).
10. Method Comparison and Bias estimation Using Patient Samples; Approved Guideline - Second Edition. CLSI
(NCCLS) document EP9-A2 (2002), 22 (19).
11. Interference Testing in Clinical Chemistry ; Approved Guideline - Second Edition. CLSI (NCCLS) document
EP7-A2 (2005), 25 (27).
12. Vassault A., et al., Ann. Biol. Clin., (1986), 44, 686
13. Berth, M. & Delanghe, J. Protein precipitation as a possible important pitfall in the clinical chemistry analysis
of blood samples containing monoclonal immunoglobulins: 2 case reports and a review of literature, Acta Clin
Belg., (2004), 59, 263.
14. Young, D.S., Effects of preanalytical variables on clinical laboratory tests, 2nd edition, AACC Press (1997).
15. Young D.S., Effects of drugs on clinical laboratory tests, 4th edition, AACC Press (1995).
SYMBOLS
In vitro diagnostic medical device
Temperature limitation
Batch code
Manufacturer
Use by
Catalogue number
European Conformity
$6$7*27
(03/2016)
FTNA-ASSL-v5
)71$$66/