This package insert follows the Pharmaceuticals, Medical devices and Other Therapeutic Products Act of Japan.
In Vitro Diagnostics
Marketing Notification No. 13A2X00197218093** Revised: January 2017 (6th edition)* Revised: August 2011 (5th edition)

This package insert must be read carefully prior to use.
γ-Glutamyltranspeptidase assay kit for blood tests(Classification No.: 38507001)

L-γ-Glutamyl-3-carboxy-4-nitroanilide+ glycylglycine

QUALIGENT γ−GT

γ-GT
L-γ-glutamyl glycylglycine+ 5-amino-2-nitrobenzoic acid (yellow)
2. Features
Final concentration of the principal ingredientmatches with the final concentration stipulated
in the JSCC Recommendation for Enzyme
Activities.

General Precautions
1. This product is for in vitro diagnostic use, andmust not be used for any other purposes.
2. Clinicians should make a comprehensive clinicaldecision based on assay results in conjunction withclinical symptoms and other examination results.
3. This product should be used only as directed in thispackage insert. Reliability of results cannot beguaranteed if there are any deviations from theinstructions in this package insert.
4. If the reagent accidentally comes in contact witheyes and/or mouth, rinse immediately with ample
water as first aid, and consult the doctor ifrequired.
5. Carefully read the operating instructions for eachtype of automated analyzers prior to using thisproduct. Parameters for each type of analyzers areavailable, and can be requested from SEKISUIMEDICAL CO., LTD. if required.
6. Perform a quality control test prior to assay toensure accuracy.

Procedural Precautions ＊＊1. Properties of Samples and Sampling Methods
1) Samples
Serum and plasma (heparin plasma, EDTA
plasma, citrated plasma and NaF-EDTAplasma) may be used.
2) Storage of samples
If the isolated serum or plasma sample cannot
be tested on the same day, they should be
stored at 2−10C or -20C.5)
Bring samples to room temperature(15−30C) before use.
2. Interfering substances
Assay results are not affected by free bilirubin (upto 20 mg/dL), conjugated bilirubin (up to 20mg/dL), hemoglobin (up to 500 mg/dL), formazinturbidity (up to 3000 FTU), or ascorbic acid (up to50 mg/dL).
3. Others
1) Always use Enzyme Calibrator Plus “Daiichi”
for calibration.
2) Precautions for assay range
If the activity of sample exceeds assay range,
dilute the sample with saline and repeat themeasurement.

Description (Kit Components) ＊＊Component: Ingredients
γ-GT Buffer Solution 1: Surfactant
γ-GT Substrate Solution 2:
L-γ-Glutamyl-3-carboxy-4-nitro
anilide・ammonium
Glycylglycine
Intended Use
Measurement of γ-glutamyltranspeptidase
serum or plasmainDosage/Administration (Assay Procedure) ＊＊1. Preparation of reagents
Reagent (1): γ−GT Buffer 1 is ready to use.
Reagent (2): γ−GT Substrate Solution 2 is readyto use.
2. Assay Procedure
This product is compatible with LABOSPECT
series automated analyzers. Assay procedure isindicated below.

γ-Glutamyltranspeptidase is an enzyme with anextremely wide distribution in human organs/tissues,
including the kidneys, pancreas, prostate, and liver.
It hydrolyzes γ-glutamyl peptide and transfers γ-glutamyl groups.
The blood level of γ-glutamyltranspeptidase activity
is mainly increased in obstructive jaundice, livercancer, and alcoholic liver disease, and is usually
determined by measuring the velocity of reaction
with a synthetic substrate.

Sample Reagent (1)+3.3 L.
100 L

Assay Principle
1. Assay Principle
γ-Glutamyltranspeptidase (γ-GTP) in the sample
transfers
theγ-glutamylgroupofL-γ-glutamyl-3-carboxy-4-nitroanilide(thesubstrate) to glycylglycine in the presence ofglycylglycine. The γ-GTP activity is determinedby measuring the velocity of production of
5-amino-2-nitrobenzoic acid, which is released at
this time.

37CMeasurement
5 min37CReagent (2)Measurement
33 L※131–299 sec (Absorbance )Calculation ofactivity※1

Absorbance: The difference in absorbance between
660 nm and 415 nm
Calibration material: Enzyme Calibrator Plus

“Daiichi” (Manufacture's assigned value)
Reagent blank: Purified water or saline

containers must be immersed in sodium
hypochlorite solution at a concentration ofgreater than 0.1% for longer than 1 hour or
autoclaved at 121ºC for 20 minutes.
2）To prevent infections from spilled samples orsolutions containing samples, wipe the spilledarea thoroughly with disinfectants such as
sodium hypochlorite solution at a concentrationof greater than 0.1%.
3) The reagents and treated samples should bediscarded as medical waste or industrial waste
according to the waste disposal regulations.
4) The reagents should be disposed of inaccordance with the Water Pollution Control act
or related regulations.
4. Other precautions
1) Do not use the containers for other purposes.
2) Do not take apart the reagent cartridge before
use.

Assessment of Assay Results ＊＊1. Reference standard range6)
Male: 13−64 U/L
Female: 9−34 U/L (≤ 45 years);
10−53 U/L (> 45 years)
2. There may be reactions or interfering reactions
with non-target substances. If assay resultsappear to be unreliable, repeat the measurement(if necessary, after dilution) or try anotheranalytical methods.
Performance ＊1. Sensitivity
1) Reagent blank: change in absorbance being
equal to or lower than 0.002/min
2) Sensitivity: The change of absorbance is0.083–0.124/min per 200U/L of
-glutamyltranspeptidase activity.
2. Accuracy: 90−110%of the expected assay value
3. Within-run Reproducibility:
Coefficient of variation ≤ 3%
(Test methods used for 1. −3. are in-housemethods.)
4. Measurement Range8): (On a Hitachi 9000 series
automated analyzer)
5−2000 U/L
5. Correlatio8)1) Serum N=100 r=0.999 y=0.98x+1.8
Control method: using an already approved invitro diagnostic product with method in linewith the JSCC Recommendation for Enzyme
Activities
2) Plasma N=115 r=0.999 y=0.99x+4.3
Control method: using an already approved invitro diagnostic product with method in linewith the JSCC Recommendation for Enzyme
Activities
6. Standard Material
Enzyme Calibrator Plus, the calibration material
used for this product, is in line with the JapaneseStandard for Certified Enzyme Reference
Materials.

Storage and Shelf Life ＊＊1. Storage temperature: 2 −10C
2. Shelf life: 1 year from the date of manufacture(The expiration date is printed on the outerpackage.)
Packaging ＊＊NameQUALIGENT γ−GT
L set
(Set for Hitachi
LABOSPECT series)

Packageγ−GT Buffer
Solution 1
1×46 mL
γ−GT Substrate
Solution 2
1×16 mL×2

References ＊＊1) Report of the Committee on Enzymes, Japan
Society of Clinical Chemistry: JCCLS Report 10,19, 1995.
2) IFCC Section No.5. 1: Clin. Chim. Acta, 135, 315
F 1983.
3) Persijn, J. P., et al.: J. Clin. Chim. Clin. Biochem,14, 421, 1976.
4) Osawa S.: Med Tech, 20, 1022, 1992
5) Medical Practice Editorial Board: Laboratory test
guide 2005-2006, 124, Bunkodo, 2005.
6) Kanai M. (supervising editor): Kanai’s manual ofclinical laboratory medicine. 34th ed. 587,
Kanehara Shuppan, 2015.
7) Japan Society of Clinical Chemistry: Jpn J Clin
Chem, 25, 135, 1996.
8) In house data, SEKISUI MEDICAL CO., LTD.

Precautions for Use or Handling ＊＊1. Precautions for Handling (to Ensure Safety)
All samples used in the test should be handled
as a material possibly infected with HIV, HBV,HCV, or other viruses. To prevent infection, use
disposable gloves and avoid mouth pipetting
during the test.
2. Precautions for use
1) This product should be stored as directed,without freezing. Freezing can deteriorate thereagents, which can produce inaccurate results.
Therefore, avoid using the reagents which havebeen previously frozen.
2) Do not use expired reagents. Use of suchreagents cannot guarantee the reliability ofmeasurement values.
3) Do not perform the assay under direct sunlight
3. Precautions for Disposal
1) Before disposal, used samples and theirContact
SEKISUI MEDICAL CO., LTD.
international@sekisui.com
Manufacturer ＊＊SEKISUI MEDICAL CO., LTD.
1-3, Nihonbashi 2-chome, Chuo-ku, Tokyo, Japan2