This package insert follows the Pharmaceuticals, Medical devices and Other Therapeutic Products Act of Japan.
In Vitro Diagnostics
Marketing Notification No.13A2X00197218096** Revised: January 2017 (11th version)* Revised: August 2011 (10th version)

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
γ-GTP────▶ L-γ-glutamyl glycylglycine+ 5-amino-2-nitrobenzoic acid (yellow)
2. Features1) Final concentration of the principal ingredientmatches with the final concentration stipulated
in the JSCC Recommendation for Enzyme
Activities.
2) Applicable to various automated analyzers.

Pureauto S GGTGeneral 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 be
guaranteed 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, EDTAplasma, 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.4)
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 (upto 50 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
GGT Reaction Solution 1:
Good’s buffer
GGT Substrate Solution 2:
L-γ-glutamyl-3-carboxy-4-nitroan
ilide
Glycylglycine
Intended Use
Measurement ofserum or plasma

γ-glutamyltranspeptidase

inDosage/Administration (Assay Procedure) ＊＊1. Preparation of reagents
Reagent (1): GGT Reaction Solution 1 is ready touse.
Reagent (2): GGT Substrate Solution 2 is ready touse.
2. Assay Procedure
This product is compatible with various types ofautomated analyzer. An example of the assay
procedure is indicated below.

γ-GTP is an enzyme with an extremely wide
distribution in human organs/tissues, including
kidneys, pancreas, prostate, and liver. It hydrolyzes
γ-glutamyl peptide and transfers γ-glutamyl groups.
The blood level of γ-GTP activity is mainly increasedin obstructive jaundice, liver cancer, and alcoholic
liver disease, and is usually determined by measuring
the velocity of reaction with a synthetic substrate.
Assay Principle
1. Assay Principle
γ-glutamyltranspeptidase (γ-GTP) in the sample
transfers
theγ-glutamylgroupof
L-γ-glutamyl-3-carboxy-4-nitroanilide(thesubstrate) to glycylglycine in the presence ofglycylglycine. The γ-GTP acitivity
isdetermined by measuring the velocity ofproduction of 5-amino-2-nitrobenzoic acid,
which is released at this time.

37CSample Reagent (1)+────▶
10 L
260 L
5 minMeasurement37CReagent (2)────▶
※130 L
60–300 sec (Absorbance )Calculation of────▶
activity※1

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

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 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
Do not use the containers for other purposes.

Assessment of Assay Results ＊＊1. Reference standard range5)
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 results appear
to be unreliable, repeat the measurement (ifnecessary, after dilution) or try another analyticalmethods.
Performance ＊1. Sensitivity
1) Reagent blank: change in absorbance being
equal to or lower than 0.002/min
2) Sensitivity: The change of absorbance is0.086–0.138/min per 500 IU/L of γ-GTP
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 Range6): (On Hitachi 7600Ds
automated analyzer)
3–2000 U/L
5. Correlation 6)
1) Serum N=100 r=0.999 y=1.00x+0.6
Control method: using an already approved invitro diagnostic product with method in linewith the JSCC Recommendation for Enzyme
Activities
2) Plasma N=90 r=0.999 y=0.99x+2.3
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 ReferenceMaterials.

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
Name
Package
GGT Reaction(1)
4 × 250 mL
Solution 1
Pureauto S
GGT
GGT Substrate(2)
4 × 100 mL
Solution 2
Constituent reagents are available in otherconfigurations. For further details please contact
SEKISUI MEDICAL CO., LTD.
References ＊＊1) Persijn J. P. et al.: J Clin Chim Clin Biochem, 14,421, 1976.
2) IFCC Section No.5. 1: Clin Chim Acta, 135, 315
F, 1983.
3) Kobayashi T. et al.: J Clin Lab Inst Reag, 14, 929,
1991.
4) Medical Practice Editorial Board: Laboratory test
guide 2005–2006, 124, Bunkodo, 2015.
5) Kanai M. (supervising editor): Kanai’s manual ofclinical laboratory medicine. 34th ed. 587,Kanehara Shuppan, 2015.
6) 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, avoidfreezing. Freezing can cause deterioration of
the reagents, leading to inaccurate results.
Therefore, do not use the product if it has beenpreviously frozen.
2) Do not use expired reagents. Use of suchreagents cannot guarantee the reliability ofmeasurement values.
3) Do not replenish the reagents.

Contact
SEKISUI MEDICAL CO., LTD.
international@sekisui.com
Manufacturer ＊＊SEKISUI MEDICAL CO., LTD.
1-3, Nihonbashi 2-chome, Chuo-ku, Tokyo, Japan2