UMA CO., LTD.

MEASURE UA
2-19-6 Yokosuka Reagent for measuring Uric Acid
Matsudo, Chiba, Japan Uricase/POD

á 2 ~ 8 °C IVD In vitro Diagnostics Packages

R1 1 ´ 90 mL R2 1 ´ 30 mL
T DO NOT freeze 6 24 months/block from light R1 1 ´ 60 mL R2 1 ´ 20 mL

1. PURPOSE OF USE 6. MEASUREMENT PRINCIPLE

In vitro determination of Uric acid in serum and plasma In the first reaction, ascorbate oxidase eliminates
ascorbate in the sample. In the second reaction, uricase
2. GENERAL INSTRUCTION
and peroxidase generate blue-violet quinine pigment which
1. For in vitro diagnostics use only.
enables the measurement of uric acid.
2. Diagnosis should be made in a comprehensive manner,
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in accordance with other related test results and clinical 2 Ascorbbate + O2 dehydroascorbate + 2H2O
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symptoms by the doctor in attendance. Uric acid + O2 + 2H2O allantoin + H2O2 + CO2
+ ,#$
3. For guaranteed results, usage of this product must 2H2O2 + 4-AA + HDAOS + H3O
blue-violet quinone pigment + 5H2O
comply with the instruction in this manual.
4. For automatic analyzers: follow their instructions. (lmax= 583 nm)

3. MATERIALS REQUIRED BUT NOT INCLUDED 7. STANDARD MEASUREMENT OPERATION

- Saline 0.9 % and high grade purified water Specimen Calibrator Blank

- Micropipet and other basic laboratory equipment. (S) (Std) (B)

- Calibrators and Controls (separatedly sold) Specimen (µL) 30 - -

Calibrator (µL) - 30 -
4. REAGENT COMPOSITION & PREPARATION
Saline (µL) - - 30
- Reagent R-1: N-(2—hydroxy-3-sulfopropyl)-3,5-
R-1 (µL) 1500 1500 1500
dimethylanilin sodium (HDAOS); Ascorbate oxidase (AOD)
Incubate at 37 °C in 5 minutes
Peroxidase
R-2 (µL) 500 500 500
Reagent R-1 is ready for use
Mix well; incubate at 37 °C for 5 minutes; measure
- Reagent R-2: Uricase; Peroxidase (POD);
absorbance at 600 nm
4-Aminoantipyrine (4-AA)
Note: See sample preparation for details of specimen
Reagent R-2 is ready for use
- Calibrator (separatedly sold); ready to use 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 UA (mg/dL) = f(∆Abs)
controls can be use without dilution. - Calculate UA concentration in specimen using the curve

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

- Serum: Collect blood sample, wait until sample completly Unit conversion

coagulated. Take the supernatant to use as specimen. 1 mg/dL = 59.4800 µmol/L

- Plasma: Treat blood sample by anticoagulant; leave it 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: Using purified water, absorbance change is
- Analyze sample soon after collection. In case, it could 0.001~ 0.050, using solution of uric acid 10mg/dL;
not be analyzed soon, store sample 2 ~ 8 °C and analyze ansorbance change is 0.040 ~ 0.200
within 3 days. - Specificity: The accuracy is within ±5.0%.

1/2 Revision 01/2014

 - Reproducibility: CV value < 3.0%. specimen and wipe it out.
- Measuring range: 0.1 ~ 20 mg/dL. Usage
Correlation Test Results 1. Store reagents under specified condition. Do not use
Serum (n=50) after expiration date.
Regression equation: Y=0.9995X－0.0522 2. Do not use the container and auxiliaries included in this
Correlation coefficient: R= 0.9978 kit for other purposes.
Plasma (n=50) 3. Do not mix reagents of different lot for use.
Regression equation: Y = Y =1.0058X－0.0454 4. Do not add to the reagent being used even if it is the
Correlation coefficient: R = 0.9992 same lot number.
(Y: value obtained from using UMA’s reagent) Disposal
Reference Materials for Calibration 1. All specimens, as well as all instruments (e.g. test tubes)
- JCCRM223 that come in contact with the specimens, must be treated by
the following methods, or they must be treated according to
10. EXPECTED VALUES
Normal reference range the manual for medical waste provided in each facility.
・ Sterilize with an autoclave, subjecting them to high
Male: 3.1~ 7.0 mg/dL.
pressure saturated steam at 121 °C for more than 20
Female: 2.5~ 6.0 mg/dL
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
comprehensive manner together with clinical symptoms ・Immerse at least one hour in sodium hypochlorite solution
(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
- There are no data for normal interference such as:
explosive metal azide. Make sure to use plenty of water at
ascorbic acid, conjugated bilirubin….
disposal. Concentration of sodium azide in R-2 is 0.05%.
- Avoid to use hemolytic sample.
14. OTHER INSTRUCTIONS AND CAUTION
12. INFORMATION FOR AUTOANALYZERS
- Results may differ depending on the sample/reagent
Calculation Method 2-point (fix)
ratio. Adjust parameters for different analyzer.
Temperature 37 °C - Prepare the calibration curve on the day of
Specimen 3.0 determination.
Volume (μL) R1 150
R2 50
Main 600
Wavelength (nm)
Sub- 800
Point 1 10
Measurement
Point 2 16
(cycle) Point 3 34

Calibration type Linear

Unit mg/dL

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
mouth by mistake, wash it immediately with plenty of water
and consult the doctor if needed.
3. If reagents are spilled, dilute with water and wipe it out. If
specimen is spilled, spray 80% of alcohol over the

2/2 Revision 01/2014