This package insert follows the Pharmaceuticals, Medical devices and Other Therapeutic Products Act of Japan.
In Vitro Diagnostics
Marketing Approval No. 21600AMZ00473000** Revised: March 2022 (8th edition)* Revised: November 2020 (7th edition)

This package insert must be read carefully prior to use.
Glucose assay kit(Classification No.: 30167002)

Intended Use
Measurement of glucose in serum, plasma, or urine

QUALIGENT GLUAssay Principle
1. Assay Principle
Glucose is converted to glucose-6-phosphate bythe action of hexokinase (HK) in the presence ofATP. Glucose-6-phosphate is converted to 6phosphogluconic acid by the action of glucose-6phosphate dehydrogenase (G-6-PDH). At thesame time, NAD is converted to NADH, and theabsorbance at 340 nm increases. The glucose levelis determined by measuring the change in theabsorbance of NADH.

Warning
Measured blood glucose levels may be higher than
the actual values in patients with pralidoxime
methyl iodide treatment. Therefore, obtain
information from the manufacturing authorization
holder of pralidoxime methyl iodide concerning its
influence on measurement of blood glucose in suchpatients.
(Measured blood glucose levels may be higher
than the actual values in patients with pralidoxime
methyl iodide treatment. If hypoglycemic drugs
such as insulin are administered on the basis of false
high values, serious symptoms of hypoglycemia
such as coma may occur.)

Glucose + ATP

HK
Mg2+

Glucose-6-phosphate + ADP

G-6-PDH
Glucose-6-phosphate + NAD
6-Phosphogluconic acid + NADH
2. Features
1) Because this product has the wide measurement
range, even urine samples can be measured
without dilution.
2) Analytical results are hardly affected byinterfering substance, because of the rate
method.
3) This product shows a high sensitivity andreproducibility.

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. For the effects of an administered drug on themeasured value, carefully read the Precautions for
Use in the package insert of the drug, especiallythe section about the effects on laboratory testresults. Please also read carefully the “2.
Interfering Substances,” in the “ProceduralPrecautions” section, as well as “2. Precautions forAssessment” in the “Assessment of Assay Results”
section, of this package insert.
4. 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.
5. 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.
6. 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.
7. Perform a quality control test prior to assay toensure accuracy.

Procedural Precautions
1. Properties of Samples and Sampling Methods
1) Samples
Serum, plasma and urine may be used.
2) Storage of samples1)
The glucose level in whole blood deceases overtime. Separate cells from the sample
immediately after collection of a blood sample.
When serum or plasma samples must be stored
after separation, store them at 2-10°C or at-20°C or lower.
Bring samples to room temperature (15-30°C)
before use.
Urine samples should be tested on the same day.
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 (upto 50 mg/dL).
3. Others* 1) Always use Serum Multicalibrater (SEKISUI)
or Anaserum GLU standard solution forcalibration.
2) Precautions for assay range
If the concentration of sample exceeds assayrange, dilute the sample with saline and repeat
the measurement.

* Description (Kit Components)
Component: Ingredients
GLU Enzyme Solution 1:
Glucose-6-phosphate
dehydrogenase
GLU Enzyme Solution 2:
Hexokinase
Nicotinamide adenine
dinucleotide (oxidized form)

1Dosage/Administration (Assay Procedure)
1. Preparation of reagents
Reagent (1): GLU Enzyme Solution 1 is ready touse.
Reagent (2): GLU Enzyme Solution 2 is ready touse.
* 2. Assay Procedure
This product is compatible with Hitachi 9000
series and LABOSPECT series automatedanalyzers. Assay procedure is indicated below.
Sample+5.0 μL

Reagent 37°C Reagent
37°C Measurement
────▶
(1)
──▶
(2)
(Absorbance†)
74-219 s
100 μL 5 min 50 μL───▶

Calculation ofconcentration†

Absorbance: The difference in absorbance between
450 nm and 340 nm
Calibration material: Serum Malticalibrater(SEKISUI) or Anaserum GLU standard solution(Manufacture's assigned value)
Reagent blank: Purified water or saline

Assessment of Assay Results* 1. Reference Interval2)
Fasting blood glucose level:73-109 mg/dL (Within the JCCLS commonstandard)* 2. Precautions for Assessment
There may be reactions or interfering reactions withnon-target substances. If assay results appear to beunreliable, repeat the measurement (if necessary,after dilution) or try another analytical methods.
Performance
1. Sensitivity
1) Reagent blank: The change of absorbance is≤ 0.005/min.
2) Sensitivity: The change of absorbance is 0.0300.060/min per 300 mg/dL of glucose.
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 Range7): (On a LABSECT 006
automated analyzer)
Serum / Plasma: 1-2000 mg/dL
Urine: 3-7200 mg/dL
5. Correlation7)
1) Serum N = 60 r = 0.999 y = 1.01x - 1.66
Control method: Approved in vitro diagnostic(hexokinase method)
2) Plasma N = 80 r = 0.999 y = 1.00x + 1.00
Control method: Approved in vitro diagnostic(hexokinase method)3) Urine N = 50 r = 0.999 y = 0.99x + 0.29
Control method: Approved in vitro diagnostic(hexokinase method)
6. Standard Material
SRM917 (NIST)

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) Sodium azide is added as an antiseptic agent in
the GLU Enzyme Solution 1 and GLU EnzymeSolution 2. Therefore, if the reagent comes in
accidentally contact with eyes, mouth or skin,rinse immediately with ample water as first aid,and consult the doctor if required.
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) The product should be tightly stoppered andstored as instructed when not in use.
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.
5) Sodium azide has been added as anantisepticagent in the GLU Enzyme Solution 1and GLU Enzyme Solution 2. It can react withlead or copper pipes to produce the highly
explosive metal azide. Therefore, the reagent
should be flushed with large amounts of water
during disposal.
4. Other precautions
1) Do not use the containers for other purposes.
2) Do not take apart the reagent cartridge before.
Storage and Shelf Life
1. Storage temperature: 2-10C
2. Shelf life: 10 months from the date of manufacture(The expiration date is printed on the outer package.)

Precautions for Use or Handling
1. Precautions for Handling (to Ensure Safety)
1) All samples used in the test should be handled

2Packaging
NamePackage
GLU Enzyme
Solution 1Set
1 × 15.0 mL(Cassette for×2
Hitachi 9000 GLU Enzymeseries)
Solution 2
1× 7.5 mL
QUALIGENTGLU Enzyme
GLU
Solution 1
L set(Set for Hitachi 1 × 40 mL
×2
LABOSPECT GLU Enzyme
Solution 2series)
1 × 20 mL
References
1) Sasaki M. et al.: Sampling of constituents of thehuman body, Tokyo: Kodansha, 1972. Japanese.
* 2) Kanai M. (supervising editor): Kanai’s manual ofclinical laboratory medicine. 35th ed. Tokyo:
Kanehara Shuppan. 2020. Japanese.
3) Kanai I and Kanai M. (author and editor): Kanai’s
manual of clinical laboratory medicine. 32nd ed.
Tokyo: Kanehara Shuppan. 2005. Japanese.
4) Mieling G. E., et al.: Clin. Chem, 25, 1581, 1979.
5) Koda K.: Med Tech, 10, 143, 1982. Japanese.
6) Nishiyama H. et al.: J Med Pharm Sci, 42(4), 647,
1999. Japanese.
7) SEKISUI MEDICAL CO., LTD. In house data.
Japanese.
Contact
SEKISUI MEDICAL CO., LTD.
international@sekisui.com

Manufacturer
SEKISUI MEDICAL CO., LTD.
1-3, Nihonbashi 2-chome, Chuo-ku, Tokyo 1030027 Japan"QUALIGENT" and "Anaserum" are trademarks orregistered trademarks of SEKISUI MEDICAL CO.,LTD. in Japan and/or other countries.
All other brands, product names and service names
are trademarks or registered trademarks of theirrespective companies.

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