This package insert follows the Pharmaceuticals, Medical devices and Other Therapeutic Products Act of Japan.
In Vitro Diagnostics
Marketing Approval No. 21600AMZ00484000**Revised: January 2017 (7th edition)*Revised: June 2014 (6th edition)

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

Procedural Precautions＊
1. Properties of Samples and Sampling Methods
1) Samples
Serum and plasma (heparin plasma, EDTA
plasma, 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, 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 sameday.
Bring samples to room temperature (15 –30C)
before use.
2. Interfering substances
1) Assay results are not affected by free bilirubin(up to 20 mg/dL), conjugated bilirubin (up to20 mg/dL), ascorbic acid (up to 50 mg/dL), orformazin turbidity (up to 3000 FTU).
2) On Hitachi 9000 series automated analyzers,
hemolysis causes the negative impact to themeasurement result. Therefore, perform
re-measurement with another device or test
method if the results obtained are extremely
low compared with those of other related
variables.
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.

QUALIGENT AMY-G2
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. 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 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.
Description (Kit Components) ＊＊Component: Ingredients
AMY-G2 Buffer Solution 1
AMY-G2 Substrate Solution 2:
α-2-Chloro-4-nitrophenyl-galacto
pyranosyl maltoside
Intended Use
Measurement of amylase in serum, plasma orurine＊＊

Dosage/Administration (Assay Procedure) ＊1. Preparation of reagents
Reagent (1): AMY-G2 Buffer Solution 1 isready to use.
Reagent (2): AMY-G2 Substrate Solution 2 isready to use
2. Assay Procedure
This product is compatible with Hitachi 9000
series and LABOSPECT series automatedanalyzers. Assay procedure is indicated below.

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.
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).

37CSample Reagent (1)+────▶
2.2 L100 L
5 min
37C
Measurement
Reagent (2)
────▶
※
33 L
98–219 sec (Absorbance )────▶ Calculation of activity※

-Amylase

Gal-G2-CNP ────▶ Gal-G2 + CNP2. Features
Reaction system based on simple measurement
principles.

1Absorbance: The difference in absorbance
between 546 nm and 415 nm (on a Hitachi 9000
series automated analyzer）
Calibration material: Enzyme Calibrator Plus
“Daiichi” (Manufacturer’s assigned value)
Reagent blank: Purified water or salinearea 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
1) Do not use the containers for other purposes.
2) Do not take apart the reagent cartridge before
use.

Assessment of Assay Results ＊1. Reference Criteria7)
In blood: 40–126 U/L
In urine: 87–665 U/L (random urine samples)
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 0.010/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-housemethods.)
4. Measurement Range8): (On Hitachi 9000 series
automated analyzers)
5–2000 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 Reference
Materials.

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＊ ＊＊NameQUALIGENTAMY-G2Package
AMY-G2
BufferSolution 1
Set
1 × 15.0 mL(Cassette forHitachi 9000
AMY-G2series)
Substrate
Solution 2
1 × 5.0 mL
AMY-G2
BufferSolution 1L set(Set for Hitachi 1 × 46.0 mL
LABOSPECT AMY-G2series)
Substrate
Solution 2
1 × 16.0 mL×2

×2

Constituent reagents are available in otherconfigurations. For further details please contact
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 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. Precautions for use
1) This product should be stored as directed, avoid
freezing. 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 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 spilled

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, 135–144, 2003.
6) Sasaki M. et al.: Sampling of constituents of thehuman body, 181, Kodansha, 1972.
7) Kosaka M. et al.: J Med Pharm Sci, 49, 503–507,
2003.
8) 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, Japan2