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IVD
GAMMA GLUTAMYL TRANSFERASE
IFCC kinetic colorimetric method
Quantitative Determination of Gamma Glutamyl
Transferase Activity [EC 2.3.2.2] in Human serum
FT En 10 Date of Updating: 10/2020 Version B
IN VITRO DIAGNOSTIC USE
Manufacturer Use by In Vitro Diagnostic Temperature
Limitation
Catalogue number See insert Store away from light Sufcient
for < n > essais
Batch number
CLINICAL SIGNIFICANCE
Serum gamma-glutamyl transferase (GGT) is exclusively of hepatobiliary origin. It is involved in ami-
no acid metabolism, through the transfer of the gamma-glutamyl group to peptides, or other amino
acids. Determination of GGT activity is part of a liver workup in individuals with high risk of liver injury
such as hepatitis, cirrhosis, excessive alcohol consumption, steatosis, or biliary tract obstruction.
Other conditions that can lead to elevated GGT such as heart failure, diabetes, pancreatic damage,
and overmedication. On the other hand, low GGT levels may indicate hypothyroidism.
PRINCIPLE
Gamma Glutamyl Transferase (Gamma-GT) catalyzes the transfer of glutamic acid to glycylglycine to
produce the 4-amino2-nitrobenzoate detected at 405 nm.
Glupa Carboxy + Glycylglycine
GGT
T L- Y Glutamylglycylglycine + 5 amino 2 nitrobenzoate
The increase in absorbance at this wavelength is directly proportional to the activity of the GammaGT.
REAGENT COMPOSITION
Reagent 1
Buffer
Glycylglycine Buffer pH 7,9
at 30°C
150 mmol/l
Reagent 2
Substrate
Glupa Carboxy 6 mmol/l
SAFETY CAUTIONS
Biomaghreb reagents are intended for use by qualified personnel for in vitro use (do not pipette by
mouth).
• Refer to the current MSDS available on request or on www.biomaghreb.com.
• Check the integrity of the reagents before use.
• Disposal of waste: comply with applicable legislation.
For safety reasons, treat any specimen or reagent of biological origin as potentially infectious. Ob-
serve the applicable legislation.
REAGENT PREPARATION
Work Solution :
Mix the substrate with 3 ml
REF
(09012),
REF
(09043) and
REF
(09050) or with10ml
REF
(09029) and
REF
(09036) of buffer R1.
SAMPLE COLLECTION AND HANDLING
Serum without hemolysis.
PRESERVATION AND STABILITY
Stored in the original, tightly stoppered bottle at 2-8°C, the reagents are stable if used and stored
under the recommended conditions:
• Before opening : Until the expiry date indicated on the label of the box at +4°C;
• After opening : (Working Solution) :
24 hours at 20-25°C;
7 days at 2-8°C.
ADDITIONAL EQUIPMENT
• Basic equipment of the medical analysis laboratory ;
• Spectrophotometer or Clinical BiochemistryAnalyzer
LIMITS
Plasma containing Citrates, Oxalates or EDTA cannot be used in this assay.
CONTROLE DE QUALITE
External quality control program.
It is recommended to control in the following cases:
• At least one test per series.
• Change of reagent bottle.
• After maintenance work on the analyzer.
If a control value is outside the confidence limits, repeat the procedure using the same control.
Use normal and pathological control sera.
LINEARITY
The method is linear up to 500 U/l at 37°C.
If the activity is higher, repeat the test by diluting the serum 1/10 with a 9 g/l Na Cl solution. Multiply
the result by 10.
PROCEDURE
Wavelength: 450 nm (410 nm);
Temperature: 25 - 30 or 37 ° C;
Tank: 1 cm thick ;
Adjust the spectrophotometer zero to air or distilled water.
Working Solution
1 ml 3 ml
Pre-incubate at the selected temperature (25, 30 or 37°C).
Sample
100 µl 300 µl
Mix and incubate 1 minute.
Measure the decrease in optical density per minute for 1 to 3 minutes.
CALCULATION AND CALIBRATION
- Use the theoretical factor at wavelength 405 nm, Ul/l = Δ DO/mn x 1346 ;
- or REF CB20003 Calbio Multicalibrator BIOMAGHREB ;
- or IFCC standard solution.
REFERENCE VALUES
25°C 30°C 37°C
Women
4 - 18 UI/l 5 - 25 UI/l 7 - 32 UI/l
Men
6 - 28 UI/l 8 - 38 UI/l 11 - 50 UI/l
REFERENCES
Lum G. and Gabino S.R. Clin. Chem. 18, 358 (1972) ;
Szasz G., Clin. Chem., 15, 124 (1969).
