UMA CO., LTD.

MEASURE GLU
2-19-6 Yokosuka Reagent for determination of Glucose
Matsudo, Chiba, Japan PROD/POD

á 2 ~ 8 °C IVD In vitro Diagnostics Packages

R1 1 ´ 90 mL R2 1 ´ 30 mL
T DO NOT freeze 6 12 months/block from light R1 1 ´ 60 mL R2 1 ´ 20 mL

1. PURPOSE OF USE - Urine: Collect into clean cup and dilute before use.
In vitro determination of Glucose in serum, plasma or - Analyze sample soon after collection. In case, it could
urine. not be analyzed soon, store sample 2 ~ 8 °C and analyze
within 3 days.
2. GENERAL INSTRUCTION
1. For in vitro diagnostics use only. 6. MEASUREMENT PRINCIPLE
2. Diagnosis should be made in a comprehensive manner, In the first reaction, ascorbate oxidase (AOD) eliminates
in accordance with other related test results and clinical ascorbic acid in the specimen. In the second reaction,
symptoms by the doctor in attendance. glucose is oxidized by pyranose oxidase and generates
3. For guaranteed results, usage of this product must H2O2. Further, in the presence of peroxidase, H2O2
comply with the instruction in this manual. generates quinine colored pigment, with which glucose can
4. For automatic analyzers: follow their instructions. be measured.
"#$
3. MATERIALS REQUIRED BUT NOT INCLUDED 2 Ascorbate + O2 2 Dehydroascorbate + 2H2O
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- Saline 0.9 % and high grade purified water D-glucose + O2 2 Dehydro-D-Glucose + H2O2
%#$
- Micropipet and other basic laboratory equipment. 2H2O2 + 4-AA + HDAOS + H3+O
Red-violet colored quinone pigment + 5H2O
- Calibrators and Controls (separatedly sold)
7. STANDARD MEASUREMENT OPERATION
4. REAGENT COMPOSITION & PREPARATION
Specimen Calibrator Blank
- Reagent R-1: N-(2-hydroxy-3-sulfopropyl)-3,5-
(S) (Std) (B)
dimethoxyaniline sodium salt (HDAOS)
Specimen (µL) 15 - -
Reagent R-1 is ready for use
Calibrator (µL) - 15 -
- Reagent R-2: Pyranose oxidase (PROD), Peroxidase
Saline (µL) - - 15
(POD), 4-Aminoantipyrine (4-AA)
R-1 (µL) 1500 1500 1500
Reagent R-2 is ready for use
Incubate at 37 °C in 5 minutes
- Calibrator (separatedly sold): Ready for use
R-2 (µL) 500 500 500
- Controls Lyo-1 & Lyo-2 (separatedly sold): Put 1 mL of
Mix well; incubate at 37 °C for 5 minutes; measure
purified water to the vials of controls (L, H); leave at room
absorbance at 585 nm
temparature for 30 minutes before use. After reconstituted,
Note: See sample preparation for details of specimen
controls can be use without dilution.

5. SAMPLE PREPARATION & STORAGE 8. CALCULATION & UNIT CONVERSION

- Serum: Collect blood sample after 12 ~ 14 hours Calculation
fasting. Wait until sample completly coagulated. Take the - Calculate ∆Abs of specimen & standards vs blank
supernatant to use as specimen. - Plot a calibration curve GLU (U/L) = f(∆Abs)

- Plasma: Collect blood sample after 12 ~ 14 hours
fasting. Treat sample by anticoagulant (i.e heparin lithium);
leave sample to stand for 3 hours or centrifuge at 2000 rpm
for 2 minutes; take the plasma layer (supernatant) and use
as specimen.
- Calculate GLU concentration in specimen using the
curve (doing same procedure for Controls)
Unit conversion
1 mg/dL = 0.0555 mmol/L

1/2 Revision 11/2013

9. PERFORMANCE & CORRELATION TEST 13. HANDLING, USAGE & DISPOSAL
Performance Handling
- Sensitivity: When using purified water, absorbance change 1. Specimen can be potentially positive for infectious agents
is 0.000 ~ 0.005; when using standard solution (D-Glucose including hepatitis B virus and HIV. Wear glove and goggle
200 mg/dL), absorbance change is in 0.550 ~ 0.755. when needed.2. In case reagents got into skin, eye or
- Specificity test: When measuring a known concentration of mouth by mistake, wash it immediately with plenty of water
control serum, the accuracy is within ±10 %. and consult the doctor if needed.
- Reproducibility Test: When identical specimens are 3. If reagents are spilled, dilute with water and wipe it out. If
measured ten times simultaneously, the within-run cv is specimen is spilled, spray 80% of alcohol over the
below 5.0%. specimen and wipe it out.
- Measuring range: Linearity up to 600 mg/dL was obtained Usage
by evaluation with control serum of known concentration. 1. Store reagents under specified condition. Do not use
Correlation test after expiration date.
Same measuring principle 2. Do not use the container and auxiliaries included in this
Serum kit for other purposes.
Regression equation Y = 0.9987X+0.5337 (n=60) 3. Do not mix reagents of different lot for use.
Correlation coefficient R = 0.9997 4. Do not add to the reagent being used even if it is the
Urine same lot number.
Regression equation Y = 1.0069X－0.5498 (n=60) Disposal
Correlation coefficient R = 0.9997 1. All specimens, as well as all instruments (e.g. test tubes)
(Y: value obtained from using UMA reagent) that come in contact with the specimens, must be treated by
the following methods, or they must be treated according to
10. EXPECTED VALUES
the manual for infectious medical waste provided in each
Normal reference range
facility.
- 70 – 109 mg/dL
・ Sterilize with an autoclave, subjecting them to high
Reference range should be established at each facility and
judgement should base on measurement results in a pressure saturated steam at 121 °C for more than 20
minutes. Do not process waste containing sodium
comprehensive manner together with clinical symptoms
hypochlorite solution with an autoclave.
and other measurement results.
・Immerse at least one hour in sodium hypochlorite solution
11. INTERFERENCES
(active chloride concentration of over 1000 ppm).
- Not available for common interferences
2. This reagent contains sodium azide. Sodium azide can
- Do not use hemolytic sample
react with lead pipe and/or steel pipe and can generate
explosive metal azide. Make sure to use plenty of water at
12. INFORMATION FOR AUTOANALYZERS
disposal. Concentration of sodium azide in R-2 is 0.05%.
Calculation Method 2-point (fix)

Temperature 37 °C 14. OTHER INSTRUCTIONS AND CAUTION

- Results may differ depending on the sample/reagent
Specimen 2.1
Volume (μL) ratio. Adjust parameters for different analyzer.
R1 210
R2 70 - Prepare the calibration curve on the day of

Main 570 determination.

Wavelength (nm)
Sub- 700
Point 1 10
Measurement
Point 2 16
(cycle) Point 3 34

Calibration type Linear

Unit mg/dL

2/2 Revision 11/2013