ABX Pentra ALT CP

ABX Pentra
Ref.: A11A01627
Volume R1: 48 ml
ALT CP
Volume R2: 12 ml

Diagnostic reagent for quantitative in-vitro 2005/04/14

A93A00022E EN

determination of Alanine AminoTransferase (ALT) in

serum or plasma. A11A01627
48 ml

Clinical Interest (1,2) 12 ml

Alanine Aminotransferase (ALAT/ALT), formerly called Glutamic
Pyruvic Transaminase (GPT) and Aspartate Aminotransferase (ASAT/
AST), formerly called Glutamic Oxalacetic Transaminase (GOT) 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. HORIBA ABX
As a liver specific enzyme ALT is only significantly elevated in BP 7290
34184 Montpellier- cedex 4 - France
hepatobiliary diseases. Increased AST levels, however, can occur in
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
Optimized UV-test according to IFCC (International Federation of Control
Clinical Chemistry) modified method without pyridoxal phosphate. For internal quality control, use:
ALT
ABX Pentra N Control, Ref. A11A01653 (not included)
L-Alanine + 2-Oxoglutarate L-Glutamate + Pyruvate 10 x 5 ml (lyophilisate)
ABX Pentra P Control, Ref. A11A01654 (not included)
LDH 10 x 5 ml (lyophilisate)
Pyruvate + NADH + H+ D-Lactate + NAD+ Each control should be assayed daily and/or after each calibration.
The frequency of controls and the confidence intervals should
(ALT = Alanine Aminotransferase, LDH = Lactate Dehydrogenase) correspond to laboratory guidelines and country-specific directives.
The results must be within the range of the defined confidence limits.
Reagents Each laboratory should establish a procedure to follow if the results
ABX Pentra ALT CP is ready-to-use. exceed these confidence limits.
Reagent 1: TRIS pH 7.5 140 mmol/l
L-Alanine 709 mmol/l Materials required but not provided
LDH (lactate dehydrogenase) ≥ 1700 U/l • Automated clinical chemistry analyser
• Standard laboratory equipment.
Sodium azide < 1 g/l
Reagent 2: 2-Oxoglutarate 85 mmol/l
Specimen
NADH 1.09 mmol/l
• Serum.
Sodium azide < 1 g/l
• heparin Plasma or EDTA Plasma.
ABX Pentra ALT CP should be used according to this reagent notice. Loss of activity within 3 days
HORIBA ABXa cannot guarantee its performance if used otherwise.
at 2 - 8 °C < 10 %
at 15 - 25 °C < 17 %
Handling
Stability at -20 °C at least 3 months
Remove both caps of the cassette, place in the refrigerated ABX Pentra
400 reagent compartment.
Form-0846 Rev. 1

If present, remove foam by using a plastic pipette.

a. Modification from index D to E: company name change.

S.A. au capital de 44.000.000 € - RCS Montpellier 328 031 042 - SIRET 328 031 042 000 42 - APE 332 B Latest version documents on www.horiba-abx.com
 ABX Pentra
ALT CP

Reference range (4) Mean value U/l CV %

37 °C Normal control 39.73 1
Women: < 31 U/l Pathological control 126.09 1.19
Men: < 41 U/l Specimen 1 17.43 3.07
Specimen 2 28.44 2.28
Storage and Stability Specimen 3 127.88 0.59
Reagents, in unopened cassettes, are stable up to the expiry date on
the label if stored at 2-8 °C protected from light and contamination is • Reproducibility (run-to-run precision)
avoided. 2 specimens of low and high levels and 2 controls are tested in
Stability after opening : refer to the paragraph ’’Performance on ABX duplicate for 20 days (2 series per day) according to the
Pentra 400’’. recommendations found in the NCCLS, EP5-A protocol (6).
Do not freeze the reagents.
Mean value U/l CV %
Normal control 39.79 2.53
Assay Procedure
Pathological control 124.91 1.77
Test instructions for other automated systems than ABX Pentra 400 are
available on request. Specimen 1 31.49 6
Specimen 2 87.6 2.48
Waste Management Linearity and Measuring Range:
1. Please refer to local legal requirements. The reagent linearity is determined according to the recommendations
2. This reagent contains sodium azide (0.95 g/l) as a preservative. As found in the NCCLS, EP6-P protocol (7).
sodium azide may react with lead or copper to form explosive metal Low linearity: 4 U/l
azides, this reagent should be disposed of by flushing with copious High linearity: 600 U/l, with automatic post-dilution: 1800 U/l.
amounts of water.
Correlation:
General Precautions 100 patient samples are correlated with a commercial reagent taken as
1. This reagent is for professional in-vitro diagnostic use only. reference according to the recommendations found in the NCCLS, EP9-
2. Do not swallow. Avoid contact with skin and mucous membranes. A2 protocol (8).
3. Take the necessary precautions for the use of laboratory reagents. The equation for the allometric line obtained is:
4. The reagent cassettes are disposable and should be disposed of in Y = x + 5 with a correlation coefficient r2 = 0.9964.
accordance with the local legal requirements.
Interferences:
5. Please refer to the MSDS associated with the reagent.
Haemoglobin: No significant influence is observed up to 195 µmol/l.
Performance on ABX Pentra 400 Triglycerides: No significant influence is observed up to 5 mmol/l.
The performance data listed below have been obtained on the ABX Total Bilirubin: No significant influence is observed up to 450 µmol/l.
Pentra 400 analyser.
Calibration stability:
Number of tests: 250 tests The reagent is calibrated on Day 0. The calibration stability is checked
by testing 2 control specimens.
On board Reagent Stability:
Once opened, the reagent cassette placed in the refrigerated ABX The calibration stability is at least 8 days.
Pentra 400 compartment is stable for 42 days.
Note: A recalibration is recommended when reagent lots change, and
Sample volume: 20 µl/test when quality control results fall outside the range established.

Detection limit: Application release: 3.00

The detection limit is determined according to the Valtec protocol (5)
and equals 4 U/l. Warning
It is the user’s responsibility to verify that this document is applicable
Accuracy and Precision: to the reagent used.
• Repeatability (within-run precision)
3 specimens of low, medium and high concentration and 2 controls are
tested 20 times according to the recommendations found in the Valtec
protocol (5).

S.A. au capital de 44.000.000 € - RCS Montpellier 328 031 042 - SIRET 328 031 042 000 42 - APE 332 B Latest version documents on www.horiba-abx.com
 ABX Pentra
ALT CP

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. Bergmeyer HU, Horder M, Rej R. International Federation of
Clinical Chemistry (IFCC) Scientific Committee, Analytical section:
approved recommendation (1985) on IFCC methods for the
measurement of catalytic concentration of enzymes. Part 3. IFCC
method for alanine aminotransferase (L-alanine:2-oxoglutarate
aminotransferase, EC 2.6.1.2). J. Clin. Chem. Clin. Biochem. 1986;
24:481-495.
4. Lorentz K, Röhle G, Siekmann L. Einführung der neuen
Standardmethoden 1994 zur Bestimmung der katalytischen
Enzymkonzentrationen bei 37 °C. DG Klinische Chemie
Mitteilungen 1995; 26:190-192.
5. Vassault A., Grafmeyer D. Naudin C. et al., Protocole de validation
de techniques (document B), Ann. Biol. Clin., 1986, 44, 686-745.
6. Evaluation of Precision Performance of Clinical Chemistry Devices,
Approved Guideline, NCCLS document EP5-A, Vol. 19, No. 2,
february 1999.
7. Evaluation of the Linearity of Quantitative Analytical Methods,
Proposed Guideline, NCCLS document EP6-P, Vol. 6, No. 18,
september 1986.
8. Method Comparison and Bias Estimation Using Patient Samples,
Approved Guideline, 2nd ed., NCCLS document EP9-A2, Vol. 22, No.
19, 2002.

S.A. au capital de 44.000.000 € - RCS Montpellier 328 031 042 - SIRET 328 031 042 000 42 - APE 332 B Latest version documents on www.horiba-abx.com
 ABX Pentra
ALT CP

S.A. au capital de 44.000.000 € - RCS Montpellier 328 031 042 - SIRET 328 031 042 000 42 - APE 332 B Latest version documents on www.horiba-abx.com