UMA CO., LTD.

MEASURE AMYG7
2-19-6 Yokosuka Reagent for measuring Amylase Activity
Matsudo, Chiba, Japan G7CNP IFCC Method

á 2 ~ 8 °C IVD In vitro Diagnostics Packages

R1 1 ´ 60 mL R2 1 ´ 12 mL
T DO NOT freeze 6 18 months/block from light R1 5 ´ 60 mL R2 5 ´ 12 mL

1. PURPOSE OF USE 6. MEASUREMENT PRINCIPLE

In vitro Determination of Amylase in blood serum, blood α-Amylase reacts with substrate ethylidene-4-
plasma or urine. nitrophenol-G7 (maltoheptaose) [ethylidene-G7
(maltoheptaose)-PNP] and isolates nitrophenol
2. GENERAL INSTRUCTION
compounds.
1. For in vitro diagnostics use only.
When α-glucosidase coexists with this reaction system,
2. Diagnosis should be made in a comprehensive manner,
in accordance with other related test results and clinical p-nitrophenol (PNP) is generated by reaction. Activity of
α-amylase can be obtained by measuring change of
symptoms by the doctor in attendance.
absorbance of PNP.
3. For guaranteed results, usage of this product must
comply with the instruction in this manual. 7. STANDARD MEASUREMENT OPERATION
4. For automatic analyzers: follow their instructions. Specimen Calibrator Blank

3. MATERIALS REQUIRED BUT NOT INCLUDED (S) (Std) (B)

- Saline 0.9 % and high grade purified water Specimen (µL) 40 - -

- Micropipet and other basic laboratory equipment. Calibrator (µL) - 40 -

- Calibrators and Controls (separatedly sold) Saline (µL) - - 40

R-1 (µL) 1000 1000 1000
4. REAGENT COMPOSITION & PREPARATION
Incubate at 37 °C in 5 minutes
- Reagent R-1: α-glucosidase
R-2 (µL) 200 200 200
Reagent R-1 is ready for use
Mix well; incubate at 37 °C for 5 minutes; measure
- Reagent R-2: ethylidene-4-nitrophenol-G7
absorbance at 405/660 nm
(maltoheptaose) ethylidene-G7 (maltoheptaose)-PNP｝
Note: See sample preparation for details of specimen
Reagent R-2 is ready for use
- Calibrators: Kanto TraceCalib PLUS is recommended 8. CALCULATION & UNIT CONVERSION
- Controls Lyo-1 & Lyo-2 (separatedly sold): Put 1 mL of Calculation
purified water to the vials of controls (L, H); leave at room - Calculate ∆Abs of specimen & standards vs blank
temparature for 30 minutes before use. After reconstituted, - Plot a calibration curve AMY (U/L) = f(∆Abs)
controls can be use without dilution. - Calculate AMY concentration in specimen using the

5. SAMPLE PREPARATION & STORAGE curve (doing same procedure for Controls)

- Serum: Wait until sample completly coagulated. Take the Unit conversion

supernatant to use as specimen. 1 U/L = 0.0166 µkat/L

- Plasma: Treat sample by anticoagulant; leave sample to 9. PERFORMANCE & CORRELATION TEST
stand for 3 hours or centrifuge at 2000 rpm for 2 minutes; Performance
take the plasma layer (supernatant) and use as specimen. - Sensitivity: Change in absorbance when measuring
- Urine: Collect in clean cup and cap tightly purified water as sample ranges from 0.00 to 0.01. Change
- Analyze sample soon after collection or store sample 2 ~ in absorbance is 0.035～0.1 Abs/min. when measuring a
8 °C and analyze within 10 days; α-amylase is unstable in standard solution of known amylase activity of 100 ～200
acidic urine, so measure it immediately after collection U/L as sample.

1/2 Revision 11/2015

 - Specificity: The accuracy is within ±10.0%. mouth by mistake, wash it immediately with plenty of water
- Reproducibility: CV value < 10.0%. and consult the doctor if needed.
- Measuring range: 2 ~ 2000 U/L. 3. If reagents are spilled, dilute with water and wipe it out. If
(Dilute the samples properly with saline & others which specimen is spilled, spray 80% of alcohol over the
showed high values exceeding upper limit of measuring specimen and wipe it out.
range or samples which are expected to show high values Usage
in advance) 1. Store reagents under specified condition. Do not use
Correlation Test after expiration date.
Same principle (serum): 2. Do not use the container and auxiliaries included in this
Regression equation: Y = 1.0067X – 1.5160 (n=61) kit for other purposes.
Correlation coefficient: R=0.9995 3. Do not mix reagents of different lot for use.
Different principle (serum) 4. Do not add to the reagent being used even if it is the
Regression equation: Y = 1.0129X – .2657 (n=67) same lot number.
Correlation coefficient: R=0.9997 Disposal
Correlation between serum and plasma samples 1. All specimens, as well as all instruments (e.g. test tubes)
Y= 1.0044 X – 1.4353 that come in contact with the specimens, must be treated by
R= 0.9995 (n=61) the following methods, or they must be treated according to
the manual for infectious medical waste provided in each
10. EXPECTED VALUES
- Serum: 37 ~ 125U/L facility.
・ Sterilize with an autoclave, subjecting them to high
- Plasma: 33 ~ 120 U/L
- Urine: 50 ~ 500 U/L pressure saturated steam at 121 °C for more than 20
minutes. Do not process waste containing sodium
Reference range should be established at each facility and
hypochlorite solution with an autoclave.
judgement should base on measurement results in a
・Immerse at least one hour in sodium hypochlorite solution
comprehensive manner together with clinical symptoms
(active chloride concentration of over 1000 ppm).
and other measurement results.
2. This reagent contains sodium azide. Sodium azide can
11. INTERFERENCES
react with lead pipe and/or steel pipe and can generate
- No influence is observed by hemoglobin up to 500 mg/dL,
explosive metal azide. Make sure to use plenty of water at
bilirubin up to 60 mg/dL and ascorbic Acid up to 100 mg/dL.
disposal. Concentration of sodium azide in R-2 is 0.05%.

12. INFORMATION FOR AUTOANALYZERS 14. OTHER INSTRUCTIONS AND CAUTION

Calculation Method Rate - Results may differ depending on the sample/reagent
ratio. Adjust parameters for different analyzer.
Temperature 37 °C
- Prepare the calibration curve on the day of
Specimen 5
determination.
Volume (μL) R1 150
R2 30
Main 405
Wavelength (nm)
Sub- 660
Point 1 10
Measurement
Point 2 24
(cycle) Point 3 34

Calibration type Linear

Unit U/L

13. HANDLING, USAGE & DISPOSAL

Handling
1. Specimen can be potentially positive for infectious agents
including hepatitis B virus and HIV. Wear glove and goggle
when needed.2. In case reagents got into skin, eye or

2/2 Revision 11/2015