Cat.

No 7-216

ACCENT-200 ALAT
APPLICATION for ACCENT-200 and ACCENT-200 II GEN
DIAGNOSTIC KIT Parameters
FOR DETERMINATION OF Test Name ALAT R1 200
ALANINE AMINOTRANSFERASE ACTIVITY Test No 15 R2 50
Full Name ALAT Sample Volume 10
INTRODUCTION Reference No 15 R1 Blank
Alanine aminotransferase (ALAT, ALT, GPT) is an enzyme Analy. Type Kinetic Mixed Reag. Blank
participated in amino acids metabolism. ALAT is present in all Pri. Wave. 340 nm Concentration 4.5 1000
tissues but the highest level is found in liver and kidney cells. Secon. Wave. 450 nm Linearity Limit 0.2
Damage of hepatocytes or kidney cells causes significant release of Trend Descending Substrate Limit
ALAT into the circulation. Measurement of ALT activity in serum is Reac. Time 4 15 Factor
valuable in the diagnosis of liver diseases: jaundice, mononucleosis Incuba. Time 10 Prozone check
or hepatic cirrhosis. Unit U/l
Precision Integer q1 q2 q3 q4
METHOD PRINCIPLE
Optimized, modified method according to International Federation of
PC Abs
Clinical Chemistry (IFCC), without pyridoxal phosphate.
Calibration Rule
L-alanine + 2-oxoglutarate ALAT pyruvate + L-glutamate Rule One-point Linear
Sensitivity 1
pyruvate + NADH + H+ LDH lactate + NAD+
Replicates 3
Interval (day) 70
The rate of absorbance changing at =340 nm is directly proportional Difference Limit 0
to alanine aminotransferase activity. SD 0
Blank Response 0 50000
REAGENTS Error Limit 0
Package Coefficient 0
1-Reagent 2 x 35 ml
2-Reagent 1 x 17.5 ml REFERENCE VALUES 6
serum / plasma 37ºC
The reagents when stored at 2-8 C are stable up to expiry date women up to 31 U/l up to 0.517 µkat/l
printed on the package. Stability on board of the analyser at 2-10 C: men up to 41 U/l up to 0.683 µkat/l
ACCENT-200 – 10 weeks, ACCENT-200 II GEN – 10 weeks. It is recommended for each laboratory to establish its own reference
Protect from light and avoid contamination! ranges for local population.
Concentrations in the test QUALITY CONTROL
Tris (pH 7.5) 100 mmol/l For internal quality control it is recommended to use the CORMAY
L-alanine 500 mmol/l SERUM HN (Cat. No 5-172) and CORMAY SERUM HP
LDH > 36.7 µkat/l (Cat. No 5-173) with each batch of samples.
2-oxoglutarate 15 mmol/l For the calibration of automatic analysers systems the CORMAY
NADH 0.18 mmol/l MULTICALIBRATOR LEVEL 1 (Cat. No 5-174; 5-176) or LEVEL
2 (Cat. No 5-175; 5-177) is recommended.
Warnings and notes The calibration curve should be prepared every 10 weeks
 Product for in vitro diagnostic use only. (ACCENT-200, ACCENT-200 II GEN), with change of reagent lot
 The reagents contain (< 0.1%) sodium azide as a preservative. number or as required e.g. quality control findings outside the
Avoid contact with skin and mucous membranes. specified range.
SPECIMEN PERFORMANCE CHARACTERISTICS
Serum, heparinized or EDTA plasma free from hemolysis. These metrological characteristics have been obtained using
Hemolysis should be avoided, since ALAT activity in erythrocytes is automatic analyser ACCENT-200. Results may vary if a different
3 to 5 times higher than in normal serum. instrument or a manual procedure is used.
Do not freeze the samples. ALAT activity remains stable in specimen
up to 3 days at 15-25ºC or up to 7 days at 2-8ºC.  Sensitivity: 4.5 U/l (0.075 µkat/l).
Nevertheless it is recommended to perform the assay with freshly
collected samples!  Linearity: up to 1000 U/l (16.7 µkat/l).
PROCEDURE  Specificity / Interferences
These reagents may be used in automatic analysers ACCENT-200 Haemoglobin up to 0.16 g/dl, ascorbate up to 62 mg/l, bilirubin
and ACCENT-200 II GEN. up to 20 mg/dl and triglycerides up to 1000 mg/dl do not
1-Reagent and 2-Reagent are ready to use. interfere with the test.
For reagent blank deionized water is recommended.

ACCENT-200 ALAT page 1

 Precision LITERATURE
Repeatability (run to run) Mean SD CV 1. Wallhofer H., Schmidt E., Schmidt U.F. W.: Synopsis Der
n = 20 [U/l] [U/l] [%] Leberkrankheiten. G. Thieme Verlag, Stuttgart (1974).
level 1 29.35 1.42 4.85 2. Thefeld W., et al: Dtsch. Med. Wschr. 99, 343 (1974).
level 2 99.75 1.61 1.61 3. Bergmeyer H.U., Horder M., Rej R.: J. Clin. Chem. Clin.
Biochem. 24, 481-495 (1986).
Reproducibility (day to day) Mean SD CV 4. Henry R.J. Cannon D.C. Winkerman J.W.: Clinical Chemistry
n = 80 [U/l] [U/l] [%] Principles and Technics, 2nd ed. Hagerstown MD: Harper and
level 1 107.86 1.65 1.53 Row, 815, 888 (1974).
level 2 208.90 11.68 5.59 5. Burtis C.A., Ashwood E.R., ed. Tietz Textbook of Clinical
Chemistry, 3rd ed. Philadelphia, PA: Moss D. W., Henderson A.
 Method comparison R., 652 (1999).
A comparison between ALAT values determined at ACCENT-200 6. Dembińska-Kieć A., Naskalski J.W.: Diagnostyka laboratoryjna
(y) and at COBAS INTEGRA 400 (x) using 100 samples gave z elementami biochemii klinicznej, Volumed, 776, (1998).
following results:
y = 0.9392 x + 2.8336 U/l;
R = 0.9966 (R – correlation coefficient) Date of issue: 03. 2012.

WASTE MANAGEMENT
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MANUFACTURER

PZ CORMAY S.A.
ul. Wiosenna 22,
05-092 Łomianki, POLAND
tel.: +48 (0) 22 751 79 10
fax: +48 (0) 22 751 79 14
http://www.pzcormay.pl

03/12/03/12

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