GAMMAGLUTAMYLTRANSFERASE

CALIBRATION ASSAY PROCEDURE

Cat. No. Pack Name Packaging (Content)
Calibration with calibrator XL MULTICAL, Cat. No. XSYS0034 is recommended. Wavelength: 405 (400 - 420 nm)
BLT00023 GGT 100 R1: 4 x 20 ml, R2: 1 x 20 ml Cuvette: 1 cm
QUALITY CONTROL
Two reagents method – substrate start
BLT00024 GGT 250 R1: 4 x 50 ml, R2: 1 x 50 ml For quality control ERBA NORM, Cat. No. BLT00080 and ERBA PATH, Cat. No.
BLT00081 are recommended. Reagent blank Calibrator Sample
Reagent 1 1.000 ml 1.000 ml 1.000 ml
EN IVD UNIT CONVERSION Sample - - 0.100 ml
U/l x 0.017 = mmol/l Calibrator - 0.100 ml -
INTENDED USE
Diagnostic reagent for quantitative in vitro determination of GGT in human serum EXPECTED VALUES 3 Distilled water 0.100 ml - -
and plasma. At 37°C Mix and after 1 min. incubation (at 37°C) add:
CLINICAL SIGNIFICANCE Male: < 55 U/l Reagent 2 0.250 ml 0.250 ml 0.250 ml
Although GGT is present in a variety of tissues, the serum enzyme appears to be Female: < 38 U/l
Mix, incubate 1 min. at 37°C and then measure the initial absorbance of calibrator
primarily from the hepato-biliary system. Consequently, GGT is elevated in all forms It is recommended that each laboratory verify this range or derives reference
and sample against reagent blank. Measure the absorbance change exactly after
of liver disease or damage. It is clinically useful in detecting obstructive jaundice, interval for the population it serves.
1, 2 and 3 min. Calculate 1 minute absorbance change (ΔA/min).
cholangitis and cholecystitis. Elevated levels are also observed with drug use (alco- PERFORMANCE DATA Monoreagent method – sample start
hol, sedatives, anticonvulsants and tranquilizers). Data contained within this section is representative of performance on ERBA XL Reagent blank Calibrator Sample
PRINCIPLE systems. Data obtained in your laboratory may differ from these values.
Working reagent 1.000 ml 1.000 ml 1.000 ml
Kinetic colorimetric method according to Persijn & van der Slik. Standardized Limit of quantification: 1.68 U/l Sample - - 0.100 ml
against recommended IFCC method. Linearity: 500 U/l
Calibrator - 0.100 ml -
GGT present in the sample catalyzes the transfer of the glutamyl group from the Measuring range: 1.68 – 500 U/l
Distilled water 0.100 ml - -
substrate γ-glutamyl-3-carboxy-4-nitroanilide to glycylglycine forming glutamyl PRECISION Mix, incubate 1 min. at 37°C and then measure the initial absorbance of calibrator
glycylglycine and 5-amino-2-nitrobenzoate.
and sample against reagent blank. Measure the absorbance change exactly after
L-γ-glutamyl-3-carboxy-4-nitroanilide + glycylglycine Intra-assay precision Mean SD CV 1, 2 and 3 min. Calculate 1 minute absorbance change (ΔA/min).
GGT Within run (n=20) (U/l) (U/l) (%)
CALCULATION
L-γ-glutamylglycylglycine + 5-amino-2nitrobenzoate Δ Asam /min.
Sample 1 91.5 0.84 0.89 1. GGT (U/l) = x Ccal Ccal = calibrator concentration
The rate of formation of 5-amino-2-nitrobenzoate is proportional to the activity Δ Acal /min.
of GGT present in the sample and can be measured kinetically at (400-420) nm. 2. Using factor: GGT (U/l) = f x ΔA/min f = factor
Sample 2 186.66 1.44 0.90 Substrate Start:
REAGENT COMPOSITION
R1 standardized against Szasz IFCC
factors at 405 nm and 37°C 1421 1606
Tris buffer (pH 8.25) 125 mmol/l
Inter-assay precision Mean SD CV Sample Start:
Glycyl Glycine 125 mmol/l
Run to run (n=20) (U/l) (U/l) (%) standardized against Szasz IFCC
R2
factors at 405 nm and 37°C 1158 1309
L-γ-Glutamyl-3-carboxy-4-nitroanilide 20 mmol/l
Sample 1 45.6 0.72 1.61 Applications for automatic analysers are available on request.
REAGENT PREPARATION
Reagent is liquid, ready to use. ASSAY PARAMETERS FOR PHOTOMETERS
Sample 2 216.5 4.14 1.91
STABILITY AND STORAGE Mode Kinetic
The unopened reagents are stable till the expiry date stated on the bottle and kit Wavelength 1 (nm) 405
label when stored at 2–8°C. COMPARISON Sample Volume (μl) 50/100
Two reagents method – substrate start A comparison between XL-Systems GGT (y) and a commercially available test (x) Working Reagent Volume (μl) 500/1000
Reagents are ready to use. using 40 samples gave following results: Lag time (sec.) 60
After opening, reagents are stable until expiry date at 2–8°C if stored at appro- y = 1.078 x + 4.50 U/l Kinetic interval (sec.) 60
priate conditions, closed carefully and without any contamination. r = 0.994 No. of readings 3
Monoreagent method – sample start Kinetic factor 1158
INTERFERENCES
Mix 4 portion of reagent R1 with 1 portion of reagent R2. Reaction temperature (°C) 37
Following substances do not interfere:
Stability: 14 days at 22–28°C in the dark Reaction direction Increasing
haemoglobin up to 5 g/l, bilirubin up to 40 mg/dl, triglycerides up to 2000 mg/dl.
6 weeks at 2–8°C in the dark Normal Low (U/l) 0
WARNING AND PRECAUTIONS
SPECIMEN COLLECTION AND HANDLING Normal High (U/l) 38
For in vitro diagnostic use. To be handled by entitled and professionally educated
Use serum, plasma (EDTA). Linearity Low (U/l) 1.68
person.
It is recommended to follow NCCLS procedures (or similar standardized conditions). Linearity High (U/l) 500
Reagents of the kit are not classified like dangerous but contain less than
Stability Blank with Water
0.1% sodium azide - classified as very toxic and dangerous substance for the
in serum / plasma: 3 days at 20–25°C Absorbance limit (max.) 1.5
environment. QUALITY SYSTEM CERTIFIED
7 days at 4–8 °C Units U/l ISO 13485
ISO 9001
1 year
at -20°C WASTE MANAGEMENT
Discard contaminated specimens. Please refer to local legal requirements.
Erba Lachema s.r.o., Karásek 1d, 621 00 Brno, CZ
12000046
12000047

e-mail: [email protected], www.erbamannheim.com

N/36/13/A/INT Date of revision: 28. 11. 2013
REFERENCES
1. Szasz G., Weimann G. Suhler F., Wahlefrld A.W., Presijn J. P. : Z Klin. Chem. Klin. Biochem. 12, 228 (1994).
2. Persijn J. P., Vander Silk W. : J. Clin. Chem. Clin. Biochem. 14, 421 - 427 (1976).
3. Tietz Textbook of Clinical Chemistry and Molecular Diagnostics. Burtis, C.A., Ashwood, E.R., Bruns, D.E.; 5th
edition, WB Saunders Comp., 2012.

SYMBOLS USED ON LABELS

REF
Catalogue Number Manufacturer
i See Instruction for Use

Lot Number CE Mark - Storage Temperature

Device comply with
the Directive 98/79/EC

Expiry Date In Vitro Diagnostics Content

IVD CONT

QUALITY SYSTEM CERTIFIED Erba Lachema s.r.o., Karásek 1d, 621 00 Brno, CZ
ISO 9001 ISO 13485 e-mail: [email protected], www.erbamannheim.com