ALAT (GPT) FS* (IFCC mod.

)
with/without Pyridoxal-5-Phosphate FS (P-5-P)
Order Information recommended cleaning solution can be specified in the
system software. Please refer to the user manual.
Cat. No. Kit size
5. Sulfasalazine and sulfapyridine medication may cause false
1 2701 99 10 920 800 (4 x 200) results in patient samples. Blood collection must be
Pyridoxal-5-Phosphate FS performed prior to drug administration.
2 5010 99 10 030 6 x 3 mL 6. In very rare cases, samples of patients with gammopathy
might give falsified results [4].
Intended Use 7. Please refer to the safety data sheets and take the necessary
precautions for the use of laboratory reagents. For diagnostic
Diagnostic reagent for quantitative in vitro determination of ALAT purposes, the results should always be assessed with the
(GPT) in human serum or heparin plasma on automated DiaSys patient’s medical history, clinical examinations and other
respons®920. findings.
8. For professional use only.
Summary
Alanine Aminotransferase (ALAT/ALT), formerly called Glutamic Waste Management
Pyruvic Transaminase (GPT) and Aspartate Aminotransferase Refer to local legal requirements.
(ASAT/AST), formerly called Glutamic Oxalacetic Transaminase
(GOT) are the most important representatives of a group of Reagent Preparation
enzymes, the aminotransferases or transaminases, which catalyze The reagents are ready to use. The bottles are placed directly into
the conversion of α-keto acids into amino acids by transfer of the reagent rotor.
amino groups. As a liver specific enzyme, ALAT is only
significantly elevated in hepatobiliary diseases. Increased ASAT For determination with P-5-P, add 350 µL of P-5-P to reagent 1
levels, however, can occur in connection with damages of heart or and mix gently.
skeletal muscle as well as of liver parenchyma. Parallel
Stability after mixing: 6 days at 2 – 8 °C
measurement of ALAT and ASAT is, therefore, applied to
24 hours at 15 – 25 °C
distinguish liver from heart or skeletal muscle damages. The
ASAT/ALAT ratio is used for differential diagnosis in liver diseases. Materials Required
While ratios < 1 indicate mild liver damage, ratios > 1 are General laboratory equipment
associated with severe, often chronic liver diseases. [1,2]
Specimen
Method
Human serum or heparin plasma
Optimized UV-test according to IFCC (International Federation of
Clinical Chemistry and Laboratory Medicine) [modified] Stability [5]:
3 days at 20 – 25°C
ALAT 7 days at 4 – 8°C
L-Alanine + 2-Oxoglutarate ◄───► L-Glutamate + Pyruvate 7 days at –20°C
LDH Only freeze once. Discard contaminated specimens.
Pyruvate + NADH + H+◄───► D-Lactate + NAD+
Calibrators and Controls
Addition of pyridoxal-5-phosphate (P-5-P), recommended by IFCC, DiaSys TruCal U calibrator is recommended for calibration. This
stabilizes the activity of transaminases and avoids falsely low method has been standardized against the original IFCC
values in samples containing insufficient endogenous P-5-P, e.g. formulation. Use DiaSys TruLab N and P for internal quality
from patients with myocardial infarction, liver disease and intensive control. Each laboratory should establish corrective action in case
care patients [1,3]. of deviations in control recovery.
Cat. No. Kit size
Reagents TruCal U 5 9100 99 10 063 20 x 3 mL
Components and Concentrations 5 9100 99 10 064 6 x 3 mL
R1: TRIS pH 7.15 140 mmol/L TruLab N 5 9000 99 10 062 20 x 5 mL
L-Alanine 700 mmol/L 5 9000 99 10 061 6 x 5 mL
LDH (lactate dehydrogenase) ≥ 2300 U/L TruLab P 5 9050 99 10 062 20 x 5 mL
R2: 2-Oxoglutarate 85 mmol/L 5 9050 99 10 061 6 x 5 mL
NADH 1 mmol/L
Pyridoxal-5-Phosphate FS Performance Characteristics
Good’s buffer pH 9.6 100 mmol/L Exemplary data mentioned below may slightly differ in case of
Pyridoxal-5-phosphate 13 mmol/L deviating measurement conditions.
Storage and Stability with P-5-P
Reagents are stable up to the date of expiry indicated on the kit, if
stored at 2 – 8°C and contamination is avoided. Do not freeze and Measuring range up to 600 U/L.
protect from light. In case of higher activities re-measure samples after manual
dilution with NaCl solution (9 g/L) or use rerun function.
Warnings and Precautions Limit of detection** 3 U/L
1. The reagents contain sodium azide (0.95 g/L) as preservative.
Onboard stability 6 days
Do not swallow! Avoid contact with skin and mucous
membranes. Calibration stability 6 days
2. Reagent 1 contains animal and biological material. Handle the
Interfering substance Interferences
product as potentially infectious according to universal
≤ 10% up to
precautions and good clinical laboratory practice.
3. Reagent 2 contains biological material. Handle the product as Ascorbic acid 30 mg/dL
potentially infectious according to universal precautions and Bilirubin (conjugated and unconjugated) 60 mg/dL
good clinical laboratory practice.
4. To avoid carryover interference, please take care of efficient Hemoglobin 200 mg/dL
washing especially after use of interfering reagents. Please Lipemia (triglycerides) 2000 mg/dL
refer to the DiaSys respons®920 Carryover Pair Table. For further information on interfering substances refer to Young DS [6,7].
Carryover pairs and automated washing steps with the

ALAT (GPT) FS (IFCC mod.) – Page 1 844 2701 10 02 73 September 2021/2

 Precision Without P-5-P
Within run (n=20) Sample 1 Sample 2 Sample 3 Women [9,10] < 31 U/L < 0.52 µkat/L
Mean [U/L] 31.6 85.3 107 Men [9,10] < 41 U/L < 0.68 µkat/L
CV [%] 2.30 0.87 0.78 Each laboratory should check if the reference ranges are
Between day (n=20) Sample 1 Sample 2 Sample 3 transferable to its own patient population and determine own
Mean [U/L] 29.7 52.8 102 reference ranges if necessary.
CV [%] 3.66 3.85 0.91 Literature
Method comparison (n=109) 1. Thomas L. Alanine aminotransferase (ALT), Aspartate
aminotransferase (AST). In: Thomas L, editor. Clinical
Test x DiaSys ALAT (GPT) FS
Laboratory Diagnostics. 1st ed. Frankfurt: TH-Books
(Hitachi 917)
Verlagsgesellschaft; 1998. p. 55-65.
Test y DiaSys ALAT (GPT) FS 2. Moss DW, Henderson AR. Clinical enzymology. In: Burtis CA,
(respons®920) Ashwood ER, editors. Tietz Textbook of Clinical Chemistry.
Slope 1.01 3rd ed. Philadelphia: W.B Saunders Company; 1999. p. 617-
721.
Intercept 0.136 U/L 3. Bergmeyer HU, Horder M, Rej R. Approved Recommendation
Coefficient of correlation 0.997 (1985) on IFCC Methods for the Measurement of Catalytic
Concentration of Enzymes. [Link]. Chem. Clin. Biochem
without P-5-P
1986; 24: 481-495.
Measuring range up to 600 U/L. 4. Bakker AJ, Mücke M. Gammopathy interference in clinical
In case of higher activities re-measure samples after manual chemistry assays: mechanisms, detection and prevention.
dilution with NaCl solution (9 g/L) or use rerun function. ClinChemLabMed 2007;45(9):1240-1243.
5. Guder WG, Zawta B et al. The Quality of Diagnostic Samples.
Limit of detection** 2 U/L 1st ed. Darmstadt: GIT Verlag; 2001; 14-5.
Onboard stability 4 weeks 6. Young DS. Effects of Drugs on Clinical Laboratory Tests. 5th
Calibration stability 4 weeks ed. Volume 1 and 2. Washington, DC: The American
Association for Clinical Chemistry Press 2000.
Interfering substance Interferences 7. Young DS. Effects on Clinical Laboratory Tests - Drugs
≤ 10% up to Disease, Herbs & Natural Products, [Link]
Ascorbic acid 30 mg/dL aaccweb/aacc/, accessed in September 2021. Published by
AACC Press and John Wiley and Sons, Inc.
Bilirubin (conjugated and unconjugated) 60 mg/dL 8. Schumann G, Bonora R, Ceriotti F, Férard G et al. IFCC
Hemoglobin 200 mg/dL primary reference procedure for the measurement of catalytic
activity concentrations of enzymes at 37°C. Part 4: Reference
Lipemia (triglycerides) 2000 mg/dL
procedure for the measurement of catalytic concentration of
For further information on interfering substances refer to Young DS [6,7]. alanine aminotransferase. Clin Chem Lab Med 2002;40:718-
Precision 24.
9. Lorentz K, Röhle G, Siekmann L. Einführung der neuen
Within run (n=20) Sample 1 Sample 2 Sample 3
Standardmethoden 1994 zur Bestimmung der katalytischen
Mean [U/L] 34.0 73.0 108 Enzymkonzentrationen bei 37 °C. DG Klinische Chemie
CV [%] 1.20 0.83 0.90 Mitteilungen 1995; Heft 4.
10. Zawta B, Klein G, Bablok W. Temperature Conversion in
Between day (n=20) Sample 1 Sample 2 Sample 3
Clinical Enzymology? Klin. Lab. 1994; 40: 33-42.
Mean [U/L] 31.3 70.2 104
DiaSys Diagnostic Systems GmbH
CV [%] 4.26 3.29 1.09 Alte Strasse 9 65558 Holzheim
Germany
Method comparison (n=96) [Link]
Test x DiaSys ALAT (GPT) FS
* Fluid Stable
(Hitachi 917)
Test y DiaSys ALAT (GPT) FS
(respons®920)
Slope 0.995
Intercept 0.00 U/L
Coefficient of correlation 0.997
** lowest measurable activity which can be distinguished from zero;
mean + 3 SD (n = 20) of an analyte free specimen.

Conversion Factor
ALAT [U/L] x 0.0167 = ALAT [µkat/L]

Reference Range
With P-5-P
Women [8] < 34 U/L < 0.57 µkat/L
Men [8] < 45 U/L < 0.75 µkat/L
Children [1] 1 – 30 Day(s) < 25 U/L < 0.42 µkat/L
2 – 12 Months < 35 U/L < 0.58 µkat/L
1 – 3 Year(s) < 30 U/L < 0.50 µkat/L
4 – 6 Years < 25 U/L < 0.42 µkat/L
7 – 9 Years < 25 U/L < 0.42 µkat/L
10 – 18 Years < 30 U/L < 0.50 µkat/L

ALAT (GPT) FS (IFCC mod.) – Page 2 844 2701 10 02 73 September 2021/2

ALAT (GPT) FS (IFCC mod.)
Application for serum and plasma
Test Details Test Volumes Reference Ranges
Test : ALT Auto Rerun ¨
Report Name : ALT(GPT) Online Calibration ¨

Unit : U/L Decimal Places : 1 Cuvette Wash ¨

Wavelength-Primary : 340 Secondary : 405 Total Reagents : 2

Assay Type : RATE - A Curve Type : Linear Reagent R1 : ALT R1

M1 Start : 0 M1 End : 0 Reagent R2 : ALT R2

M2 Start : 20 M2 End : 31

Sample Replicates : 1 Standard Replicates : 3 Consumables/Calibrators:

Control Replicates : 1 Control Interval : 0 Blank /Level 0 0
Reaction Direction : Decreasing React. Abs. Limit : 0.51(0.30)** Calibrator 1 *
Prozone Limit % : 0 Prozone Check : Upper
Linearity Limit % : 0 Delta Abs. / Min. : 0.0000
Technical Minimum : 3.0 Technical Maximum : 600.0
Y = aX + b a= : 1.0000 b= : 0.0000

* Enter calibrator value. ( )** With pyridoxal-5-phosphate

Test Details Test Volumes Reference Ranges

Test : ALT

Sample Type : Serum

Sample Volumes Sample Types

þ Serum
Normal : 12.00 µL Dilution Ratio : 1 X o Urine
o CSF
Increase : 20.00 µL Dilution Ratio : 1 X
þ Plasma
Decrease : 5.00 µL Dilution Ratio : 1 X o Whole Blood
o Other
Standard Volume : 12.00 µL

Reagent Volumes and Stirrer Speed

RGT-1 Volume : 160 µL R1 Stirrer Speed : Medium

RGT-2 Volume : 40 µL R2 Stirrer Speed : High

Test Details Test Volumes Reference Ranges

Test : ALT

Sample Type : Serum

Reference Range : DEFAULT

Category : Male

Reference Range Sample Types

þ Serum
Lower Limit Upper Limit o Urine
o CSF
(U/L) (U/L)
þ Plasma
o Whole Blood
Normal : 0.00 45.00 o Other
Panic : 0.00 0.00

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