ABX Pentra AST CP

ABX Pentra
Ref.: A11A01629
Volume R1: 56 ml
AST CP
Volume R2: 14 ml

Intended use 2007/06/27

A93A00032E US
Diagnostic reagent for quantitative in-vitro
determination of Aspartate AminoTransferase (AST)
A11A01629
in serum or plasma.
56 ml

Clinical Interest (1,2) 14 ml

Aspartate Aminotransferase (ASAT/AST), formerly called Glutamic
Oxalacetic Transaminase (GOT) and Alanine Aminotransferase (ALAT/
ALT), formerly called Glutamic Pyruvic Transaminase (GPT) are the
most important representatives of a group of enzymes, the
aminotransferases or transaminases, which catalyze the conversion of
α-keto acids into amino acids by transfer of amino groups.
As a liver specific enzyme ALT is only significantly elevated in HORIBA ABX
hepatobiliary diseases. Increased AST levels, however, can occur in BP 7290
34184 Montpellier- cedex 4 - France
connection with damages of heart or skeletal muscle as well as of liver
parenchyma. Parallel measurement of ALT and AST is therefore applied
to distinguish liver from heart or skeletal muscle damages. The AST/
ALT ratio is used for differential diagnosis in liver diseases. While Calibrator
ratios < 1 indicate mild liver damage, ratios > 1 are associated with For calibration, use:
severe, often chronic liver diseases. ABX Pentra MultiCal, Ref. A11A01652 (not included)
10 x 3 ml (lyophilisate)
Method (3)
Optimized UV-test according to IFCC (International Federation of Control
Clinical Chemistry) modified method without pyridoxal phosphate. For internal quality control, use:
AST ABX Pentra N Control, Ref. A11A01653 (not included)
L-Aspartate + 2-Oxoglutarate L-Glutamate + 2-Oxalacetate
10 x 5 ml (lyophilisate)
ABX Pentra P Control, Ref. A11A01654 (not included)
MDH 10 x 5 ml (lyophilisate)
Oxalacetate + NADH + H+ L-Malate + NAD+

(AST = Aspartate Aminotransferase, MDH = Malate Dehydrogenase) Each control should be assayed daily and/or after each calibration.
The frequency of controls and the confidence intervals should
Reagents correspond to laboratory guidelines and country-specific directives.
ABX Pentra AST CP is ready-to-use. The results must be within the range of the defined confidence limits.
Each laboratory should establish a procedure to follow if the results
Reagent 1: TRIS pH 7.8 110 mmol/l exceed these confidence limits.
L-Aspartate 340 mmol/l
MDH (malate dehydrogenase) ≥ 900 U/l Materials required but not provided
LDH (lactate dehydrogenase) ≥ 900 U/l • Automated clinical chemistry analyser: ABX PENTRA 400
Sodium azide < 1 g/l • Calibrator: ABX Pentra Multical, Ref. A11A01652
Reagent 2: 2-Oxoglutarate 85 mmol/l • Controls: ABX Pentra N Control, Ref. A11A01653, and
NADH 1.09 mmol/l ABX Pentra P Control, Ref. A11A01654
Sodium azide < 1 g/l • Standard laboratory equipment.

ABX Pentra AST CP should be used according to this reagent notice. Specimen
HORIBA ABX cannot guarantee its performances if used otherwise. • Serum.
• Plasma in lithium heparin.
Handling
Remove both caps of the cassette, place in the refrigerated ABX Pentra Stability (1): stable for 1 week in serum at 4-8°C
400 reagent compartment. continuous slight decrease in activity at room temperature.
Form-0846 Rev. 2

If present, remove foam by using a plastic pipette.

S.A.S. au capital de 41.700.000 € - RCS Montpellier 328 031 042 - SIRET 328 031 042 000 42 - APE 332 B Latest version documents on www.horiba-abx.com
 ABX Pentra
AST CP

Reference range (3) Accuracy and Precision:

Each laboratory should establish its own reference ranges. The values • Repeatability (within-run precision)
given here are used as guidelines only. 3 specimens of low, medium and high concentration and 2 controls are
tested 20 times according to the recommendations found in the Valtec
37 °C protocol (4).
Women: < 31 U/l
Men: < 35 U/l Mean value U/l CV %
Control specimen 1 42.21 2.71
Storage and Stability Control specimen 2 123.45 1.43
Reagents, in unopened cassettes, are stable up to the expiry date on Specimen 1 21.76 2.32
the label if stored at 2 - 8 °C, and contamination is avoided. Specimen 2 38.36 2.01
Stability after opening : refer to the paragraph ’’Performance on ABX Specimen 3 145.42 1.08
Pentra 400’’.
Do not freeze the reagents. • Reproducibility (total precision)
2 specimens of low and high levels and 2 controls are tested in
duplicate for 20 days (2 series per day) according to the
Assay Procedure
recommendations found in the CLSI (NCCLS), EP5-A protocol (5).
Test instructions for other automated systems than ABX Pentra 400 are
available on request (not available in the USA). Mean value U/l CV %
Control specimen 1 41.58 3.15
Waste Management Control specimen 2 126.33 2.50
1. Please refer to local legal requirements. Specimen 1 42.87 3.62
2. This reagent contains less than 0.1% of sodium azide as a Specimen 2 348.17 4.97
preservative. As sodium azide may react with lead or copper to
form explosive metal azides, this reagent should be disposed of by Measuring Range:
flushing with copious amounts of water. The assay confirmed a measuring range from 3.70 U/l to 671.80 U/l,
providing an upper linearity of 600 U/l, with an automatic post-
General Precautions dilution up to 1800 U/l
1. This reagent is for professional in-vitro diagnostic use only. The linearity is determined according to the recommendations found
2. Do not swallow. Avoid contact with skin and mucous membranes. in the CLSI (NCCLS), EP6-A protocol (6).
3. Take the necessary precautions for the use of laboratory reagents.
Correlation:
4. The reagent cassettes are disposable and should be disposed of in
113 patient samples (serum) are correlated with a commercial reagent
accordance with the local legal requirements.
taken as reference according to the recommendations found in the
5. Please refer to the MSDS associated with the reagent.
CLSI (NCCLS), EP9-A2 (7). Values ranged from 3.70 to 671.80 U/l.
The equation for the allometric line obtained is:
Performance on ABX Pentra 400 Y = 0.99 x + 1.01 with a correlation coefficient r2 = 0.9966.
The performance data listed below have been obtained on the ABX
Pentra 400 analyser. Interferences:

Number of tests: 250 tests Haemoglobin: No significant influence is observed up to 95 mg/dl

Triglycerides: No significant influence is observed up to 402.5 mg/dl
On board Reagent Stability: (as Intralipid®, representative of lipemia)
Once opened, the reagent cassette placed in the refrigerated ABX Total Bilirubin: No significant influence is observed up to 415 µmol/l
Pentra 400 compartment is stable for 55 days. Direct Bilirubin: No significant influence is observed up to 362 µmol/l
Sample volume: 20 μl/test Calibration stability:
Detection limit: The reagent is calibrated on Day 0. The calibration stability is checked
The detection limit is determined according to the Valtec protocol (4) by testing 2 control specimens.
and equals 4 U/l. The calibration stability is at least 8 days.

Note: A recalibration is recommended when reagent lots change, and

when quality control results fall outside the range established.

Application releasea: 2.xx

a.Modification from index D to E: suppression of minor index.

S.A.S. au capital de 41.700.000 € - RCS Montpellier 328 031 042 - SIRET 328 031 042 000 42 - APE 332 B Latest version documents on www.horiba-abx.com
 ABX Pentra
AST CP

Warning
It is the user’s responsibility to verify that this document is applicable
to the reagent used.

Reference
1. Thomas L. Alanine aminotransferase (ALT), Aspartate
aminotransferase (AST). In: Thomas L, editor. Clinical Laboratory
Diagnostics. 1st ed. Frankfurt: TH-Books Verlagsgesellschaft; 1998.
p. 55-65.
2. Moss DW, Henderson AR. Clinical enzymology. In: Burtis CA,
Ashwood ER, editors. Tietz Textbook of Clinical Chemistry. 3rd ed.
Philadelphia: W.B Saunders Company; 1999. p. 617-721.
3. IFCC Primary Reference Procedures for the Measurement of
Catalytic Activity Concentrations of Enzymes at 37°C. Part 5, Clin.
Chem. Lab. Med. 2002; 40(7): 725-733.
4. Vassault A., Grafmeyer D. Naudin C. et al., Protocole de validation
de techniques (document B), Ann. Biol. Clin., 1986, 44, 686-745.
5. Evaluation of Precision Performance of Clinical Chemistry Devices,
Approved Guideline, CLSI (NCCLS) document EP5-A, Vol. 19, No. 2,
february 1999.
6. Evaluation of the Linearity of Quantitative Analytical Methods,
Approved Guideline, CLSI (NCCLS) document EP6-A, Vol. 23, No.
16, april 2003.
7. Method Comparison and Bias Estimation Using Patient Samples,
Approved Guideline, 2nd ed., CLSI (NCCLS) document EP9-A2, Vol.
22, No. 19, 2002.

S.A.S. au capital de 41.700.000 € - RCS Montpellier 328 031 042 - SIRET 328 031 042 000 42 - APE 332 B Latest version documents on www.horiba-abx.com
 ABX Pentra
AST CP

S.A.S. au capital de 41.700.000 € - RCS Montpellier 328 031 042 - SIRET 328 031 042 000 42 - APE 332 B Latest version documents on www.horiba-abx.com