This package insert follows the Pharmaceuticals, Medical devices and Other Therapeutic Products Act of Japan.
In Vitro Diagnostics
Marketing Approval No. 20600AMZ01041000** Revised: November 2020 (8th edition)* Revised: January 2017 (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

Pureauto S GLUThe blood level of glucose is increased due to its
intestinal absorption, hepatic degradation of glycogen,and gluconeogenesis (formation of glucose from othersubstances), while it is decreased due to formation ofglycogen, oxidative degradation in the tissues, andconversion to lipids. Also, because in vivo glucose
metabolism is regulated by the endocrine system andthe autonomic nervous system, detection of abnormal
blood and urinary glucose levels is important in thediagnosis and evaluation of these diseases.

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 behigher than the actual values in patients withpralidoxime methyl iodide treatment. If
hypoglycemic drugs such as insulin areadministered on the basis of false high values,
serious symptoms of hypoglycemia such as coma
may occur.)

Assay Principle
1. Assay Principle
Glucose is converted to glucose-6-phosphate by
the 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 the sametime, NADP is converted to NADPH, and theabsorbance at 340 nm increases. The glucose levelis determined by measuring the change in theabsorbance of NADPH.

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. For the effects of an administered drug on themeasured value, carefully read the Precautions for
Use in the package insert of the drug, especially thesection about the effects on laboratory test results.
Please also read carefully the “2. Interfering
Substances,” in the “Procedural Precautions”
section, as well as “2. Precautions for Assessment”
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.

Glucose + ATP

HK

Glucose-6-phosphate + ADP

Mg2+
G-6-PDH
Glucose-6-phosphate + NADP
6-Phosphogluconic acid + NADPH
2. Features
1) Liquid reagents, ready-to-use.
2) Hemolysis and bilirubin have minimal effects
on results.
3) This product shows a high sensitivity andreproducibility.
4) Applicable to various automated analyzers.
＊ ＊Procedural Precautions＊
1. Properties of Samples and Sampling Methods
1) Samples
Serum, plasma （ citrated plasma ） and urine
may be used.
2) Storage of samples4)
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 (15–30oC)
before use.
Urine samples should be tested on the sameday.
2. Interfering substances
Assay results are not affected by free bilirubin (upto 50 mg/dL), conjugated bilirubin (up to 50mg/dL), hemoglobin (up to 500 mg/dL), or＊ ＊Description (Kit Components) ＊Component: Ingredients
GLU Enzyme Solution 1:
Hexokinase
Glycose-6-phosphate dehydrogenase
Nicotinamide adenine dinucleotide
phosphate (oxidized form)
GLU Reactant Solution 21

ascorbic acid (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 assay
range, dilute the sample with saline and repeat
the measurement.
＊

Control method: Approved in vitro diagnostic(glucokinase method)3) Urine N=50 r=0.999 y=0.99x+1.13
Control method: Approved in vitro diagnostic(hexokinase method)
6. Standard Material
SRM917（NIST）
Precautions for Use or Handling ＊1. Precautions for Handling (to Ensure Safety)
1) All samples used in the test should be handled asa 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 Reactant
Solution 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) 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 orautoclaved 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 Reactant 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
Do not use the containers for other purposes.

＊

Dosage/Administration (Assay Procedure) ＊1. Preparation of reagents
Reagent (1): GLU Enzyme Solution 1 is readyto use.
Reagent (2): GLU Reactant 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.
37°CMeasurement
Sample Reagent (1)+───▶
3 μL
260 μL(Absorbance I※)
5 min
37°C
Measurement
Reagent (2)───▶
130 μL(Absorbance II※)
5 min
─── Calculation of─▶ concentration※

Absorbance I and II: The difference in absorbance
between 450 nm and 340 nm.
Calibration material: Serum Multicalibrater(SEKISUI) or Anaserum GLU standard solution(Manufacture's assigned value)
Reagent blank: Purified water or saline＊ ＊Assessment of Assay Results ＊1. Reference standard range1)
Fasting blood glucose level:
73–109 mg/dL (Within the JCCLS commonstandard)
2. Precautions for Assessment
There may be reactions or interfering reactions with
non-target substances. If assay results appear to beunreliable, repeat the measurement (if necessary, afterdilution) or try another analytical methods.
Performance ＊1. Sensitivity
1) Reagent blank: absorbance being equal to or
lower than 0.05
2) Sensitivity: The absorbance is 0.58–0.87 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 Range5): (On Hitachi 7170S
automated analyzer)
1–1000 mg/dL
5. Correlation5)
1) Serum N=100 r=0.999 y=0.99x+0.42
Control method: Approved in vitro diagnostic(hexokinase method)
2) Plasma N=50 r=0.999 y=0.99x+0.80

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 outer package.)2

Packaging
NamePackage
GLU Enzyme(1)
2×400 mL
Solution 1
Pureauto S
GLU
GLU Reactant(2)2×200 mL
Solution 2
Constituent reagents are available in otherconfigurations. For further details please contact
SEKISUI MEDICAL CO., LTD.
＊ ＊References ＊1) Kanai M. (supervising editor): Kanai’s manual ofclinical laboratory medicine. 35th ed. 519,
Kanehara Shuppan, 2020.
2) Meiling G. E. et al.: Clin. Chem, 25, 1581, 1979.
3) Koda K.: Med Tech, 10, 143, 1982.
4) Sasaki M. et al.: Sampling of constituents of thehuman body, 237, Kodansha, 1972.
5) In house data, SEKISUI MEDICAL CO., LTD.
Contact
SEKISUI MEDICAL CO., LTD.
international@sekisui.com
Manufacturer ＊SEKISUI MEDICAL CO., LTD.
1-3, Nihonbashi 2-chome, Chuo-ku, Tokyo, Japan"Pureauto" 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 aretrademarks or registered trademarks of their respective
companies.

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