This package insert follows the Pharmaceuticals, Medical devices and Other Therapeutic Products Act of Japan.
In Vitro Diagnostics
Marketing Notification No. 13A2X00197218084**Revised: January 2017 (10th edition)*Revised: August 2011 (9th edition)

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

L-γ-glutamyl glycylglycine+ 5-amino-2-nitrobenzoic acid (yellow color)
2. Features
1) Final concentration of the principal ingredientmatches with the final concentration stipulated
in the JSCC Recommendation for EnzymeActivities.
2) Applicable to various automated analyzers.

Pureauto S γ-GT
General Precautions
1. This product is for in vitro diagnostic use, and mustnot 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 if required.
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, EDTAplasma, citrated plasma and NaF-EDTAplasma) may be used.
2) Storage of samples
If the serum or plasma sample cannot beanalyzed on the day of separation, store it withrefrigeration (2–10°C) or store it frozen (-20°Cor lower). 5)
Bring samples to room temperature (15–30C)
before use.
2. Interfering substances
Assay results are not affected by free bilirubin (upto 40 mg/dL), conjugated bilirubin (up to 40mg/dL), hemoglobin (up to 500 mg/dL), formazinturbidity (up to 5600 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-4nitroanilide ammonium
Glycylglycine
Intended Use
Measurement ofserum or plasma

γ-glutamyltranspeptidaseinDosage/Administration (Assay Procedure) ＊＊1. Preparation of reagents
Reagent (1): γ-GT Buffer Solution 1 is ready touse.
Reagent (2): γ-GT Substrate Solution 2 is readyto use.
2. Assay Procedure
This product is compatible with various types ofautomated analyzer. An example of the assay
procedure is indicated below.

γ-glutamyltranspeptidase (γ-GT) 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 γglutamyl groups.
The blood level of γ-GT activity is mainly increased in
obstructive jaundice, liver cancer, and alcoholic liverdisease, and is extensively determined by measuring
the velocity of reaction with a synthetic substrate.

Sample + Reagent (1)10 μL
270 μL

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

37 C
5 min
37 C

Measurement
Reagent (2)※90 μL 120 - 300 sec (Absorbance )Calculation ofactivity※Absorbance: The difference in absorbance between
660 nm and 405 nm.
Calibration material: Enzyme Calibrator Plus
“Daiichi” (Manufacture's assigned value)
Reagent blank: Purified water or saline

L-γ-Glutamyl-3-carboxy-4-nitroanilide +glycylglycine1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
Do not use the containers for other purposes.

Assessment of Assay Results ＊＊1. Reference standard range6)
Male:
16–64 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 results appear
to be unreliable, repeat the measurement (ifnecessary, after dilution) or try another analyticalmethods.

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.)

Performance ＊1. Sensitivity
1) Reagent blank: change in absorbance being
equal to or lower than 0.002/min
2) The change of absorbance is 0.083–0.124/min
per 200 U/L of γ-GT 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-house methods.)
4. Measurement Range8): (On Hitachi 7600Ds
automated analyzer)
1–2000 U /L
5. Correlation8)
1) Serum N=100
r=0.999
y=0.98x+1.8
Control method: using an already approved in vitro
diagnostic product with method in line with theJSCC Recommendation for Enzyme Activities
2) Plasma N=90
r=0.999
y=1.01x+0.1
Control method: using an already approved in vitro
diagnostic product with method in line with theJSCC 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.

PackagingNamePackage
γ-GT Buffer
2 × 400 mL
Solution 1(1)γ-GT Buffer
4 × 85 mL
Solution 1
Pureauto S
γ-GT
γ-GT Substrate
2 × 150 mL
Solution 2(2)γ-GT Substrate
4 × 45 mL
Solution 2Constituent reagents are available in otherconfigurations. For further details please contact
SEKISUI MEDICAL CO., LTD.
References ＊＊1) Enzyme Committee of the Japan Society ofClinical 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 testguide 2015, 135, Bunkodo, 2015.
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 amaterial possibly infected with HIV, HBV, HCV, orother 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 replenish the reagents.
4) Do not perform the assay under direct sunlight
3. Precautions for Disposal
1) Before disposal, used samples and theircontainers must be immersed in sodium
hypochlorite solution at a concentration ofgreater than 0.1% for longer than 1 hour or
autoclaved at 121 ºC for 20 minutes.
2) To prevent infections from spilled samples orsolutions containing samples, wipe the spilledarea thoroughly with disinfectants such asContact
SEKISUI MEDICAL CO., LTD.
international@sekisui.com
Manufacturer ＊＊SEKISUI MEDICAL CO., LTD.
1-3, Nihonbashi 2-chome, Chuo-ku, Tokyo, Japan2