2015/12/23

Clinical Chemistry A93A01297BUS

A11A01630

56 mL
ABX Pentra 14 mL

GGT CP

■ Pentra C400

Diagnostic reagent for quantitative in vitro determination of Gamma-

GlutamylTransferase (GGT) in serum by colorimetry.

Application Release a to acceptors like glycylglycine in this case. This process

releases 5-amino-2-nitrobenzoate, which can be
measured at 405 nm. The increase in absorbance at this
Serum: GGT wavelength is directly related to the activity of gamma-
GT.
1.xx
Gamma-GT
L-Gamma-glutamyl-3-carboxy-4- <——> Gamma-glutamyl-glycylglycine +
nitranilide + Glycylglycine 5‑Amino-2-nitrobenzoate
Intended Use

ABX Pentra GGT CP reagent is intended for the

quantitative in vitro diagnostic determination of Gamma-
Reagents
GlutamylTransferase (GGT) in serum or plasma.
Gamma-glutamyltranspeptidase measurements are used ABX Pentra GGT CP is ready-to-use.
in the diagnosis and treatment of liver diseases such as
alcoholic cirrhosis and primary and secondary liver Reagent 1:
tumors. TRIS pH 8.25 137 mmol/L
Glycylglycine 137 mmol/L

Clinical Interest (1) Sodium azide < 1 g/L

Gamma-glutamyltransferase (Gamma-GT or GGT), also Reagent 2:

called gamma-glutamyltranspeptidase, is an enzyme L-Gamma-glutamyl-3-carboxy-4-nitroanilide 22 mmol/L
present in liver and bile duct which is the most sensitive Sodium azide < 1 g/L
indicator of hepatobiliary diseases. Because of a high
negative predictive value for these diseases the ABX Pentra GGT CP should be used according to this
measurement of gamma-GT is widely used to rule out an reagent notice. The manufacturer cannot guarantee its
hepatic or biliary origin. Together with other enzymes performance if used otherwise.
such as alanine aminotransferase (ALAT), aspartate
aminotransferase (ASAT) and cholinesterase gamma-GT
is a valuable tool for the differential diagnosis in liver
diseases. Handling

1. Remove both caps of the cassette.

Method (2) 2. If present, remove foam by using a plastic pipette.
QUAL-QA-TEMP-0846 Rev.9

Kinetic photometric test according to Szasz modified 3. Place the cassette into the refrigerated Pentra C400
(1974). Gamma-GT catalyzes the transfer of glutamic acid reagent compartment.

aModification: specimen changed.

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 Clinical Chemistry

ABX Pentra
GGT CP

37°C
Women: ≤ 38 U/L
Calibrator Men: ≤ 55 U/L

For calibration, use:

ABX Pentra Multical, Ref. A11A01652 (not included) Storage and Stability
10 x 3 mL (lyophilisate)
Reagents, in unopened cassettes, are stable up to the
expiry date on the label if stored between 2-8°C.
Control
Stability after opening: refer to the paragraph
For internal quality control, use: "Performance on Pentra C400".
ABX Pentra N Control, Ref. A11A01653 (not included)
10 x 5 mL (lyophilisate) Do not freeze the reagents.
ABX Pentra P Control, Ref. A11A01654 (not included)
10 x 5 mL (lyophilisate)
Waste Management
Each control should be assayed daily and/or after a
calibration.
■ Please refer to local legal requirements.
The frequency of controls and the confidence intervals
■ This reagent contains less than 0.1% of sodium azide
should correspond to laboratory guidelines and country-
specific directives. You should follow federal, state and as a preservative. Sodium azide may react with lead
local guidelines for testing quality control materials. The and copper to form explosive metal azides.
results must be within the range of the defined confidence
limits. Each laboratory should establish a procedure to
follow if the results exceed these confidence limits. General Precautions b

■ This reagent is for professional in vitro diagnostic use

Materials Required but not Provided only.
■ For prescription use only.
■ Automated clinical chemistry analyzer: Pentra C400 ■ This reagent is classified as non-hazardous in
■ Calibrator: ABX Pentra Multical, Ref. A11A01652 compliance with regulation (EC) N°.1272/2008.
■ Controls: ■ Do not swallow. Avoid contact with skin and mucous
ABX Pentra N Control, Ref. A11A01653, and membranes.
ABX Pentra P Control, Ref. A11A01654 ■ Observe the standard laboratory precautions for use.
■ Standard laboratory equipment. ■ The reagent cassettes are disposable and should be
disposed of in accordance with the local legal
requirements.
Specimen ■ Please refer to the MSDS associated with the reagent.
■ Do not use the product if there is visible evidence of
biological, chemical or physical deterioration.
■ Serum.
■ It is the user's responsibility to verify that this
document is applicable to the reagent used.
Stability (3):

■ At 20-25°C: 7 days
■ At 4-8°C: 7 days Performance on Pentra C400
■ At -20°C: 1 year
The performance data listed below are representative of
performance on HORIBA Medical Systems.
Reference Range (4)
Number of Tests: 250 tests c
Each laboratory should establish its own reference If the number of tests requested is low and the
ranges. The values given here are used as guidelines only. Pentra C400 user intends to utilise the cassette to the

bModification: general precautions modification.

cModification: reference for kit membrane changed.

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 Clinical Chemistry

ABX Pentra
GGT CP

maximum on board stability, it is the recommendation of Correlation:

HORIBA Medical, to utilise the consumable part XEC232
(Kit membrane) to achieve the number of tests stated in 100 patient samples (serum) are correlated with a
this notice. commercial reagent taken as reference according to the
recommendations found in the CLSI (NCCLS), EP9-A2
On Board Reagent Stability: protocol (8).
The equation for the allometric line obtained using
Once opened, the reagent cassette placed in the Passing-Bablock regression procedure (9) is:
refrigerated Pentra C400 compartment is stable for 21 Y = 1.14 X - 2.54 (U/L)
days. with a correlation coefficient r2 = 0.9984.
Sample Volume: 10 µL/test
Interferences:
Detection Limit:
Haemoglobin: No significant influence is observed up
The detection limit is determined according to the Valtec to 55 µmol/L (95 mg/dL).
protocol (5) and equals 4 U/L. Triglycerides: No significant influence is observed up
to an Intralipid® concentration
Accuracy and Precision: (representative of lipemia) of
7 mmol/L (612.5 mg/dL).
■ Repeatability (within-run precision) Total Bilirubin: No significant influence is observed up
to 404 µmol/L (23.6 mg/dL).
3 specimens of low, medium and high concentration and Direct Bilirubin: No significant influence is observed up
2 controls are tested 20 times according to the to 116 µmol/L (6.8 mg/dL).
recommendations found in the Valtec protocol (5). Other limitations are given by Young as a list of drugs and
preanalytical variables known to affect this methodology
Mean value U/L CV % (10, 11).
Control specimen 1 40 3.38
Control specimen 2 207 0.70 Calibration Stability:
Specimen 1 47 3.37
The reagent is calibrated on Day 0. The calibration
Specimen 2 53 1.41 stability is checked by testing 2 control specimens.
Specimen 3 394 0.82 The calibration stability is 8 days.
Note: A recalibration is recommended when reagent lots
■ Reproducibility (total precision) change, and when quality control results fall outside the
range established.
2 specimens (medium and high levels) and 2 controls are
tested in duplicate for 20 days (2 series per day) Application release:
according to the recommendations found in the CLSI
(NCCLS), EP5-A protocol (6). 1.xx

Mean value U/L CV %

Reference
Control specimen 1 39 5.13
1. Thomas L. Gamma glutamyltransferase (GGT). In:
Control specimen 2 210 2.95
Thomas L. editor. Clinical Laboratory Diagnostics. 1st
Specimen 1 43 5.75 ed. Frankfurt: TH-Books Verlagsgesellschaft (1998):
Specimen 2 399 3.69 80-86.
2. Persijn JP, Van der Silk W. A new method for the
Measuring Range: determination of gamma-glutamyltransferase in
serum. J. Clin. Chem. Clin. Biochem. (1976) 14:
The assay confirmed a measuring range from 4.0 to 421-427.
1000.0 U/L, with an automatic post-dilution up to 3. Use of anticoagulants in diagnostic laboratory
3000.0 U/L. investigations. WHO publication WHO/DIL/LAB/99.1
The reagent linearity has been assessed up to 1000.0 U/L Rev.2 (2002).
according to the recommendations found in the CLSI
(NCCLS), EP6-A protocol (7).

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 Clinical Chemistry

ABX Pentra
GGT CP

4. IFCC Primary Reference Procedures for the

Measurement of Catalytic Activity Concentrations of
Enzymes at 37°C; Part 6; Clin. Chem. Lab. Med.
(2002) 40 (7): 734-738.
5. Vassault A, Grafmeyer D, Naudin C et al. Protocole
de validation de techniques (document B). Ann. Biol.
Clin. (1986) 44: 686-745.
6. Evaluation of Precision Performance of Clinical
Chemistry Devices. Approved Guideline, CLSI
(NCCLS) document EP5-A (1999) 19 (2).
7. Evaluation of the Linearity of Quantitative Analytical
Methods. Approved Guideline, CLSI (NCCLS)
document EP6-A (2003) 23 (16).
8. Method Comparison and Bias Estimation Using
Patient Samples. Approved Guideline, 2nd ed., CLSI
(NCCLS) document EP9-A2 (2002) 22 (19).
9. Passing H, Bablock W. A new biometrical procedure
for testing the equality of measurements from two
different analytical methods. J. Clin. Chem. Clin.
Biochem. (1983) 21: 709-20.
10. Young DS. Effects of Drugs on Clinical Laboratory
Tests. 4th Edition, Washington, DC, AACC Press
(1997) 3: 143-163.
11. Young DS. Effects of Preanalytical Variables on
Clinical Laboratory Tests. 2nd Edition, Washington,
DC, AACC Press (1997) 3: 120-132.

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