ELITech Clinical Systems

Selectra Pro Series Analyzers

AST/GOT 4+1 SL
References : Kit composition :
ASSL-0250 8 x 25 mL R1: 8 x 20 mL + R2: 8 x 5 mL
In vitro diagnostic reagent, for professional use only ASSL-0455 4 x 55 mL R1: 4 x 44 mL + R2: 4 x 11 mL

CAUTION: Federal Law restricts this device to sale by or on the order of a licensed healthcare Conversion factor: U/L x 0.0167 = μkat/L
practitioner (Rx ONLY)
PROCEDURE
INTENDED USE See application included in the barcode indicated at the end of the insert.
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 CALIBRATION
Analyzers. Aspartate aminotransferase (AST) measurements are used in the diagnosis and treatment of certain
For calibration, multiparametric calibrator Elical 2 must be used. Its value is traceable to IFCC reference method (5).
types of liver and heart diseases.
Calibration frequency: refer to § PERFORMANCE DATA.
It is not intended for use in Point of Care settings*.

CLINICAL SIGNIFICANCE (1-4)
Aspartate aminotransferase (AST), also known as glutamate oxaloacetate transaminase (GOT), is a transaminase.
AST catalyses the 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.
Damage to cells of these tissues induces AST increase in serum. In case of fulminant forms of hepatitis, especially
viral hepatitis the enzyme level is markedly elevated. In case of myocardial infarction, AST activity increases and
reaches a peak after 18-24 hours. The activity falls back to normal after 4-5 days, provided no new infarct has
occurred.
The following pathological states are examples of disorders also resulting in an increase of enzyme activity : liver cell
necrosis or injury of any cause (for example intake of alcohol, delirium tremens, and administration of drug induce
moderate AST elevation), alcoholic hepatitis, muscular dystrophy and gangrene, infectious mononucleosis, acute
pancreatitis, cardiac afflictions such as myocarditis or pericarditis, pulmonary emboli...
AST serum level can be decreased in case of vitamin B6 deficiency.
METHOD (5)
IFCC method without pyridoxal phosphate (P-5’-P).
Kinetic. UV.
QUALITY CONTROL
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.
PERFORMANCE DATA at 37°C:
A) On ELITech Clinical Systems Selectra ProM Analyzers
- 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
μkat/L). Samples exceeding 250.0 U/L should be diluted 1:10 with NaCl 9 g/L solution (normal saline) and re-
assayed. Use of this procedure extends the measuring range to 250.0 to 2500.0 U/L (4.17 to 41.67 μkat/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%.

The « rerun dilution » function performs the sample dilution automatically. Results take the dilution into account.
PRINCIPLE (5)
Kinetic determination of aspartate aminotransferase (AST) activity : - Limit of Detection (LoD) and Limit of quantification (LoQ)
AST Determined according to CLSI(8) EP 17-A protocol.
L-Aspartate + α-Ketoglutarate Oxaloacetate + L-Glutamate LoD = 0.8 U/L (0.01 μkat/L)
MDH LoQ = 5.0 U/L (0.08 μkat/L)
Oxaloacetate + NADH + H+ L-Malate + NAD+
MDH = Malate dehydrogenase. - Precision
Determined according to CLSI(9) EP5-A2 protocol.
REAGENTS COMPOSITION Mean Within-run Total
Reagent 1 : R1
Tris buffer, pH 7.80 (30°C) 100 mmol/L n U/L μkat/L CV (%)
L-Aspartate 330 mmol/L
Low level 40 21.0 0.35 1.6 2.1
Lactate dehydrogenase (LDH) (microorganisms) ≥ 2000 U/L
Malate dehydrogenase (MDH) (bacterial) ≥ 1000 U/L Medium level 40 54.1 0.90 0.6 1.5
Sodium azide < 0.1 % High level 40 201.0 3.35 0.2 1.4
Reagent 2 : R2 - Correlation
α-Ketoglutarate 78 mmol/L A comparative study has been performed between an ELITech Clinical Systems Selectra ProM Analyzer and ano-
NADH 1.1 mmol/L ther FDA-Approved system equipment (IFCC method without pyridoxal phosphate) on 100 human serum samples
Sodium azide < 0.1 % according to CLSI(10) EP9-A2 protocol.
The sample concentrations were between 9.9 and 248.1 U/L (0.17 and 4.14 μkat/L).
MATERIAL REQUIRED BUT NOT PROVIDED The parameters of the linear regressions are as follows :
- ELICAL 2, calibrator, ref.CALI-0580, 4 x 3 mL. Correlation coefficient: (r) =0.999
- ELITROL I, control serum, ref.CONT-0080, 10 x 5 mL. Linear regression: y = 1.029 x - 0.2 U/L
- ELITROL II, control serum, ref.CONT-0180, 10 x 5 mL.
- General Laboratory equipment. - Interferences
Studies have been performed to determine the level of interference from different compounds according to CLSI(11)
WARNINGS AND PRECAUTIONS EP7-A2 protocol and SFBC recommendations(12). Recovery within ± 10% of initial value at AST activity of 50 U/L
- These reagents are for professional in vitro diagnostic use only. and 200 U/L.
- Take normal precautions and adhere to good laboratory practice. Unconjugated Bilirubin: No significant interference up to 30 mg/dL (513 μmol/L).
- Use clean or single use laboratory equipment only to avoid contaminations. Conjugated Bilirubin: No significant interference up to 29.5 mg/dL (504 μmol/L).
- The reagents contain less than 0.1 % sodium azide. Sodium azide can react with copper and lead plumbing to Turbidity: No significant interference up to 614 mg/dL (6.94 mmol/L) Triglyceride equiva-
form explosive metal azides. If discharged in the plumbing system, rinse with plenty of water. -lent.
- For more information, Safety Data Sheet (SDS) is available on request for the professional user. Ascorbic acid: No significant interference up to 20 mg/dL (1136 μmol/L).
Pyruvate: No significant interference up to 3 mg/dL (340 μmol/L).
WASTE MANAGEMENT
Disposal of all waste material should be in accordance with local, state and Federal regulatory requirements. In very rare cases, monoclonal gammopathies (multiple myeloma), in particular IgM type (Waldenstrom’s macro-
globulinemia) can cause unreliable results.(13)
STABILITY OF REAGENTS
Other compounds may interfere.(14,15)
Store at 2-8 °C and protect from light.
The reagents are stable until the expiry date stated on the label. Note : Hemolyzed samples should not be used since significant hemolysis may increase AST concentration because
On board stability: Refer to § PERFORMANCE DATA. of high levels of AST in erythrocytes.

PREPARATION - On board stability/Calibration frequency

The reagents are ready to use. On Board Stability : 28 days
Calibration frequency : 28 days
REAGENT DETERIORATION Recalibrate when reagent lots change, when quality control results fall outside the established range, and after
The reagent solutions should be clear. Cloudiness would indicate deterioration. a maintenance operation.

SAMPLES (2, 6) B) On ELITech Clinical Systems Selectra ProS Analyzers

- Specimen
Serum free from hemolysis. - Measuring range
Lithium heparinized plasma, free from hemolysis. 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
μkat/L). Samples exceeding 250.0 U/L should be diluted 1:10 with NaCl 9 g/L solution (normal saline) and re-
- Storage assayed. Use of this procedure extends the measuring range to 250.0 to 2500.0 U/L (4.17 to 41.67 μkat/L). This
Samples are stable 24 hours at room temperature, 7 days at 2-8°C and 3 months at -20°C. 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%.
REFERENCE VALUES (2)
Serum, plasma (37°C): < 40 U/L The « rerun dilution » function performs the sample dilution automatically. Results take the dilution into account.
Reference values for infants are higher than for adults.

Note : It is recommended that each laboratory establishes and maintains its own reference values. The data given .../...
here are only for information.

* : US FDA only (03/2016)

: Modification from previous version FTNA-ASSL-v5
ELITech Clinical Systems SAS  For Technical questions, Please call or contact
Zone Industrielle (855) 354-8324 - www.elitechgroup.com
61500 SEES 27 Wellington Road
France Lincoln, Rhode Island 02865 - U.S.A.
 ELITech Clinical Systems
Selectra Pro Series Analyzers
AST/GOT 4+1 SL
References : Kit composition :
ASSL-0250 8 x 25 mL R1: 8 x 20 mL + R2: 8 x 5 mL
In vitro diagnostic reagent, for professional use only ASSL-0455 4 x 55 mL R1: 4 x 44 mL + R2: 4 x 11 mL

- Limit of Detection (LoD) and Limit of quantification (LoQ)

Determined according to CLSI(8) EP 17-A protocol.
LoD = 1.8 U/L (0.03 μkat/L)
LoQ = 5.0 U/L (0.08 μkat/L)

- Precision
Determined according to CLSI(9) EP5-A2 protocol.
Mean Within-run Total
n U/L μkat/L 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 ano-
ther 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 μkat/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 μkat/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 μmol/L).
Conjugated Bilirubin: No significant interference up to 29.5 mg/dL (504 μmol/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 μmol/L).
Pyruvate: No significant interference up to 3 mg/dL (340 μmol/L).
In very rare cases, monoclonal gammopathies (multiple myeloma), in particular IgM type (Waldenstrom’s macro-
globulinemia) 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

Consult instruction for use Batch code

Manufacturer Use by

Catalogue number European Conformity

$6$7*27 
 )71$$66/

(03/2016)
: Modification from previous version FTNA-ASSL-v5

ELITech Clinical Systems SAS  For Technical questions, Please call or contact
Zone Industrielle (855) 354-8324 - www.elitechgroup.com
61500 SEES 27 Wellington Road
France Lincoln, Rhode Island 02865 - U.S.A.