This package insert follows the Pharmaceuticals, Medical devices and Other Therapeutic Products Act of Japan.
In Vitro Diagnostics
Marketing Approval No. 21200AMZ00392000**Revised: February 2021 (9th edition)*Revised: January 2017 (8th edition)

This package insert must be read carefully prior to use.
Amylase assay kit(Classification No.:38502002)

Gal-G2-CNP
Gal-G2 + CNP
2. Features
1) Liquid reagents, ready-to-use.
2) Applicable to various automated analyzers.

Pureauto S AMY-G2
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.
Read carefully the “2. Interfering Substances,” inthe “Procedural Precautions” section, as well as “2.
Precautions for Assessment” in the “Assessment ofAssay 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 (heparin plasma, EDTA plasma,
citrated plasma and NaF-EDTA plasma) andurine may be used.
2) Storage of samples
If the isolated serum or plasma sample cannot
be tested on the same day, specimens should be
stored as follows6):
2–10C: for tests within 3 weeks≤ -20C: for tests after more than 3 weeks
Urine samples should be tested on the same day.
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), ascorbic
acid (up to 50 mg/dL), or formazin turbidity (up to5600 FTU).
3. Others
1) Always use Enzyme Calibrator Plus “Daiichi”
for calibration material.
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
AMY-G2 Buffer Solution1AMY-G2 Substrate Solution 2:
α-2-Chloro-4-nitrophenylgalactopyranosyl maltoside

Dosage/Administration (Assay Procedure) ＊1. Preparation of reagents
Reagent (1): AMY-G2 Buffer Solution 1 is readyto use.
Reagent (2): AMY-G2 Substrate Solution 2 isready to use
2. Assay Procedure
This product is compatible with various types ofautomated analyzer. An example of the assay
procedure is indicated below.

Intended Use
Measurement of amylase in serum, plasma or urine
Amylase is a digestive enzyme. It is found in thepancreatic fluid, saliva, blood, and urine. Because theserum amylase level increases rapidly in acutepancreatitis and other diseases, the measurement ofamylase is important for the diagnosis of pancreaticdisease.

Sample+4 μL

37C
5 min
37CMeasurement
Reagent (2)90–210 sec (Absorbance※)
60 μL

Assay Principle ＊＊1. Assay Principle
When blood or urinary amylase (-amylase) actson-2-chloro-4-nitrophenyl-galactopyranosyl
maltoside (Gal-G2-CNP) as the substrate, it isdecomposed to form 4-galactopyranosyl maltose(Gal-G2) and 2-chloro-4-nitrophenol (CNP).
Amylase activity is determined by measuring thevelocity of CNP production (yellow color).
- Amylase

Reagent (1)180 μL

Calculation of activity※

Absorbance: The difference in absorbance between
546 nm and 405 nm
Calibration material: Enzyme Calibrator Plus
“Daiichi” (Manufacture's assigned value)
Reagent blank: Purified water or saline1＊2) To prevent infections from spilled samples orsolutions containing samples, wipe the spilledarea thoroughly with disinfectants such assodium 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 in accordancewith the Water Pollution Control act or relatedregulations.
4. Other precautions
Do not use the containers for other purposes.

＊Assessment of Assay Results ＊1. Reference standard range7)
Serum: 44–132 U/L (JCCLS common standardrange)
Urine: 50–500 U/L (reference value)
2. Precautions for Assessment
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 0.010/min
2) Sensitivity: The change of absorbance is0.017–0.027/min per 100 U/L of amylase.
2. Accuracy: 90–110% of the expected assay value
3. Within-run reproducibility:
Coefficient of variation ≤5%(Test methods used for 1–3 are in-house methods.)
4. Measurement Range8): (On Hitachi 7600Dsautomated analyzer)
2–2000 U/L
5. Correlation 8)
1) Serum N=54 r=0.999 y=0.97x＋5.8
Control method: Approved in vitro diagnostic(CNP G3 method)
2) Plasma N=136 r=0.999 y=0.98x＋0.7
Control method: Approved in vitro diagnostic(CNP G5 method)3) Urine N=55 r=0.999 y=0.99x＋17
Control method: Approved in vitro diagnostic(CNP G3 method)
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 ＊NamePackage
AMY-G2 Buffer(1) Solution 1
2 × 50 mL
Pureauto S
AMY-G2AMY-G2 Substrate(2) Solution 2
2 × 20 mL
Constituent reagents are available in otherconfigurations. For further details please contact
SEKISUI MEDICAL CO., LTD.
＊ ＊References ＊1) Jpn J Clin Med, 57 (extra edition), 359–361, 1999.
2) Morishita Y., et al.: Jpn J Clin Chem, 46, 928−933,2000.
3) Ikeda K. et al.: J Jpn Soc Clin Labo Autom, 27,183–188, 2002.
4) Suzuki H. et al.: J Jpn Soc Clin Labo Autom, 27,229–232, 2002.
5) Noguchi M. et al.: J Clin Lab Inst Reag, 26, 135144, 2003.
6) Sasaki M. et al.: Sampling of constituents of thehuman body, 181, Kodansha, 1972.
7) Kanai M. (supervising editor): Kanai’s manual ofclinical laboratory medicine. 35th ed. 609,Kanehara Shuppan, 2020.
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, 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.
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.

Contact
SEKISUI MEDICAL CO., LTD.
international@sekisui.com
Manufacturer ＊SEKISUI MEDICAL CO., LTD.
1-3, Nihonbashi 2-chome, Chuo-ku, Tokyo, Japan"Pureauto" is a trademark or registered trademark ofSEKISUI MEDICAL CO., LTD. in Japan and/or othercountries.
All other brands, product names and service names aretrademarks or registered trademarks of their respective
companies.

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