BIOLABO

www.biolabo.fr
ALT GPT ( I F CC )
MANUFACTURER: Reagent for quantitative determination of Alanine amino transferase activity (ALT)
BIOLABO SAS, [EC 2.6.1.2] in human serum and plasma
Les Hautes Rives
02160, Maizy, France

REF K1507 R1 2 x 16 mL R2 1 x 8 mL
REF K2507 R1 2 x 32 mL R2 2 x 8 mL
REF K4507 R1 2 x 40 mL R2 1 x 20 mL

| IVD
TECHNICAL SUPPORT AND ORDERS
Tel: (33) 03 23 25 15 50
Made In France
[email protected]
Latest revision: www.biolabo.fr I: corresponds to significant modifications

INTENDED USE SAFETY CAUTIONS

This reagent is designated for professional use in laboratory · Refer to current Material Safety Data Sheet available on request or
(automated method). on www.biolabo.fr
I It allows the quantification of global activity of the alanine amino · Verify the integrity of the contents before use.
transferase (ALT) enzyme in human serum and plasma. · Waste disposal: Respect legislation in force in the country.
· All specimens or reagents of biological origin should be handled as
GENERALITIES (1) (2) potentially infectious. Respect legislation in force in the country.
ALT is present in very high amounts in liver and kidney, and in smaller I Any serious incident that has occurred in connection with the device
is notified to the manufacturer and the competent authority of the
amounts in skeletal muscle and heart. Although serum levels of both
Member State in which the user and/or patient is based.
AST and ALT become elevated whenever diseases process affecting
liver cells integrity, ALT is the more liver-specific enzyme. REAGENTS PREPARATION
A serum elevation of ALT activity is rarely observed in conditions other
Ready for use.
than parenchymal liver disease (cirrhosis, carcinoma, hepatitis,
obstructive jaundice or liver stroke).
STABILITY AND STORAGE
Stored away from light, well cap in the original vial at 2-8°C,
PRINCIPLE (4) (5) (6) reagents are stable when stored and used as described in the
Method developed by Wrobleski and La Due, optimised by Henry and insert:
Bergmeyer (following modified IFCC recommendations). Reaction Unopened,
scheme is as follows: · Until the expiry date stated on the label of the Kit.
L- Alanine + 2-Oxoglutarate ALT Pyruvate + L-Glutamate Once opened:
· 2 separated reagents are stable 6 months
· Discard any reagent if cloudy or if blank reagent at 340nm < 1.000.
LDH
Pyruvate + NADH + H+ L-Lactate + NAD+
The decrease in absorbance proportional to ALT activity in the SPECIMEN COLLECTION AND HANDLING (2) (7)
specimen, is measured at 340 nm. Unhemolysed serum. Do not use heparinised plasma.
Absence of P5P allows a better stability of working reagent. ALT is stable in serum or plasma for:
· 24 hours at room temperature.
REAGENTS COMPOSITION · 7 days at 2-8°C.

R1 AL2 Buffer enzymes

LIMITS (3) (6)
L-Alanine 700 mmol/L LDH contained in reagent allows, during pre-incubation step, the
LDH > 2500 UI/L reduction of endogenous pyruvate which would positively interfere.
EDTA 6 mmol/L Elevated ALT level may involve NADH depletion during pre-incubation
Tris Buffer 135 mmol/L stage, which may lead to under-estimated results.
pH at 30°C 7.50 + 0.1 In case of lipemic or icteric specimens, increased absorbance may
Stabilizer mask this phenomenon. It’s recommended to check these specimens
diluted (1 + 4) in saline solution.
R2 AL2 Coenzyme For a more comprehensive review of factors affecting this assay refer
Tris Buffer 20 mmol/L to the publication of Young D.S.
NADH < 1.4 mmol/L
2-Oxoglutarate 80 mmol/L MATERIAL REQUIRED BUT NOT PROVIDED
Stabilizer 1. Basic medical analysis laboratory equipment.
According to 1272/2008/EC Regulation, these reagents are not 2. Biochemistry Clinical Analyzer Kenza One, Kenza 240TX/ISE or
classified as dangerous Kenza 450TX/ISE

AL2_DT_200a_IFU_K1507-K2507-K4507_EN_V03_20210330
REFERENCE INTERVALS (2) CALIBRATION

(IU/L) 37°C · REF 95015 Multicalibrator traceable to ERM-AD454k

The calibration frequency depends on proper instrument functions and
Newborns, Infants 13-45 on the preservation of reagent.

Men 10-40
QUALITY CONTROL
Women 7-35
· REF 95010 EXATROL-N Level I
Each laboratory should establish its own normal ranges for the · REF 95011 EXATROL-P Level II
population it serves. · External quality control program
It is recommended to control in the following cases:
PERFORMANCES · At least once a run
· At least once within 24 hours
On Kenza One, 37°C, 340 nm.
· When changing vial of reagent
Linearity Range: between 18 and 500 IU/L · After maintenance operations on the instrument
Detection limit: approx. 3 IU/L If control is out of range, apply following actions:
Precision: 1. Prepare a fresh control serum and repeat the test
2. If control is still out of range, use a new vial of fresh calibrator
Within-run Low Normal High Between run Low Normal High 3. If control is still out of range, use a new vial of reagent and reassay
N = 20 level level level N = 20 level level level
If control is still out of range, please contact BIOLABO technical
Mean (IU/L) 20 59 211 Mean (IU/L) 22 60 213 support or your local Agent.
S.D. IU/L 0.9 1.3 1.8 S.D. IU/L 1.2 1.9 4.3
C.V. % 4.2 2.3 0.8 C.V. % 5.3 3.2 2.0 PROCEDURE
Refer to validated application of the Kenza Analyzer used
Analytical sensitivity: approx. 0.0054 abs/min for 10 IU/L
Interferences: CALCULATION
Total bilirubin Negative interference from 219 µmol/L The analyzer provides directly result in IU/L.
Direct bilirubin No interference up to 492 µmol/L Refer to the instruction of use of Kenza analyzer.
Ascorbic acid No interference up to 2500 mg/dL
Glucose No interference up to 1120 mg/dL REFERENCES
Turbidity Positive interference from 0.143 OD (1) TIETZ N.W. Textbook of clinical chemistry, 3rd Ed. C.A. Burtis, E.R.
Haemoglobin Positive interference from 209 µmol/L Ashwood, W.B. Saunders (1999) p. 652-657
(2) Clinical Guide to Laboratory Test, 4th Ed., N.W. TIETZ (2006) p. 64-67
Other substances may interfere (see § Limits) (3) YOUNG D.S., Effect of Drugs on Clinical laboratory Tests, 4th Ed. (1995) p.
3-6 to 3-16.
On the board stability: 2 separate reagents are stable 30 days.
(4) HENRY R. J. andt al., Am J clin Path (1960), 34, 398
Calibration Frequency: 30 days (5) Bergmeyer HU.,and al. Clin. Chem. (1978), 24, p.58-73
Make a new calibration when changing reagent batch, if quality control (6) IFCC Method for L-Alanine aminotransferase. J Clin. Chem., Clin.
Biochem.(1986), 24, p.481-495).
results are found out of the established range and after maintenance
(7) MURRAY RL., « Alanine aminotransironase » in clinical chemistry. Theory,
operations.
analysis, and correlation.Kapan LA, Pesce AJ, (Eds), CV Mosby St Louis
Comparison studies on Kenza 240TX with commercially available (1984): 1090
reagent:
Realised on human specimens (n=100) between 5 and 400 IU/L
y = 0.9900 x + 0.2592 r = 0.9985
Performances and stability data on Kenza 450TX/ISE and
Kenza 240TX/ISE are available on request

IVD H2O

Manufacturer Expiry date In vitro diagnostic Storage temperature Dematerialized water Biological risk

REF LOT ®
Product Reference See Insert Batch number Store away from light Sufficient for Dilute with

AL2_DT_200a_IFU_K1507-K2507-K4507_EN_V03_20210330