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    MEASURE GLU (Fixed)

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    This document provides instructions for using a glucose reagent kit to determine glucose levels in serum, plasma, or urine samples. The kit contains two reagents, R1 and R2, which are used in an enzymatic colorimetric assay. Glucose is oxidized to produce a colored product that can be measured spectrophotometrically. The kit has a measuring range of 2-600 mg/dL and shows good correlation and reproducibility. Proper sample collection and handling is required, and various precautions are outlined to ensure safe use of the reagents.

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    MEASURE GLU (Fixed)

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    Trần Văn Bình
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    This document provides instructions for using a glucose reagent kit to determine glucose levels in serum, plasma, or urine samples. The kit contains two reagents, R1 and R2, which are used in an enzymatic colorimetric assay. Glucose is oxidized to produce a colored product that can be measured spectrophotometrically. The kit has a measuring range of 2-600 mg/dL and shows good correlation and reproducibility. Proper sample collection and handling is required, and various precautions are outlined to ensure safe use of the reagents.

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    MEASURE GLU ( Fixed )

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    This document provides instructions for using a glucose reagent kit to determine glucose levels in serum, plasma, or urine samples. The kit contains two reagents, R1 and R2, which are used in an enzymatic colorimetric assay. Glucose is oxidized to produce a colored product that can be measured spectrophotometrically. The kit has a measuring range of 2-600 mg/dL and shows good correlation and reproducibility. Proper sample collection and handling is required, and various precautions are outlined to ensure safe use of the reagents.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    80 views3 pages

    MEASURE GLU (Fixed)

    Uploaded by

    Trần Văn Bình
    This document provides instructions for using a glucose reagent kit to determine glucose levels in serum, plasma, or urine samples. The kit contains two reagents, R1 and R2, which are used in an enzymatic colorimetric assay. Glucose is oxidized to produce a colored product that can be measured spectrophotometrically. The kit has a measuring range of 2-600 mg/dL and shows good correlation and reproducibility. Proper sample collection and handling is required, and various precautions are outlined to ensure safe use of the reagents.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    of 3

    UMA CO., LTD.

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

    　2 ~ 8 °C IVD In vitro Diagnostics Packages


    R1: 90 mL R2: 30 mL
    　DO NOT freeze  12 months/block from light R1: 60 mL R2: 20 mL

    1. PURPOSE OF USE analyzed soon, store sample 2 ~ 8 C and analyze within 3 days.
    In vitro Determination of Glucose in serum, plasma or urine.
    6. MEASUREMENT PRINCIPLE
    2. GENERAL INSTRUCTION In the first reaction, ascorbate oxidase (AOD) eliminates ascorbic
    1. For in vitro diagnostics use only. acid in the specimen. In the second reaction, glucose is oxidized
    2. Diagnosis should be made in a comprehensive manner, in by pyranose oxidase and generates H2O2. Further, in the
    accordance with other related test results and clinical symptoms presence of peroxidase, H2O2 generates quinine colored pigment,
    by the doctor in attendance. with which glucose can be measured.
    3. For guaranteed results, usage of this product must comply with 2 Ascorbate + O2 AOD2 Dehydroascorbate + 2H O 2

    the instruction in this manual. →

    4. Follow the automatic analyzers instructions carefully. D-glucose + O2


    ∏ →¿ ¿ 2 Dehydro-D-Glucose + H O 2 2

    3. MATERIALS REQUIRED BUT NOT INCLUDED


    - Saline 0.9 % and high grade purified water 2H2O2 + 4-AA + HDAOS + H3+O POD
    →
    - Micropipet and other basic laboratory equipment.
    Red-violet colored quinone pigment + 5H2O
    - Calibrators and Controls (separatedly sold)
    7. CALCULATION & UNIT CONVERSION
    4. REAGENT COMPOSITION & PREPARATION
    Calculation
    - Reagent R-1: N-(2-hydroxy-3-sulfopropyl)-3,5- dimethoxyaniline
    - Calculate ∆Abs of specimen & standards vs blank
    sodium salt (HDAOS)
    - Plot a calibration curve GLU (U/L) = f(∆Abs)
    Reagent R-1 is ready for use
    - Calculate GLU concentration in specimen using the curve
    - Reagent R-2: Pyranose oxidase (PROD), Peroxidase (POD), 4-
    (doing same procedure for Controls)
    Aminoantipyrine (4-AA)
    Unit conversion
    Reagent R-2 is ready for use
    1 mg/dL = 0.0555 mmol/L
    - Calibrator (separatedly sold): Ready for use
    - Controls Lyo-1 & Lyo-2 (separatedly sold): Put 1 mL of purified
    water to the vials of controls (L, H); leave at room temparature for
    30 minutes before use. After reconstituted, controls can be use
    without dilution.

    5. SAMPLE PREPARATION & STORAGE


    - Serum: Collect blood sample after 12 ~ 14 hours fasting. Wait
    until sample completly coagulated. Take the supernatant to use as
    specimen.
    - 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.
    - Urine: Collect into clean cup and dilute before use.
    - Analyze sample soon after collection. In case, it could not be

    1/3 Revision 11/2013


    8. PERFORMANCE & CORRELATION TEST Temperature 37 C
    Performance Specimen 2.1

    - Sensitivity: When using purified water, absorbance change is Volume (μL) R1 210

    0.000 ~ 0.005; when using standard solution (D-Glucose 200 R2 70


    Main 570
    mg/dL), absorbance change is in 0.550 ~ 0.755. Wavelength (nm)
    Sub- 800
    - Specificity test: When measuring a known concentration of control
    Point 1 0
    serum, the accuracy is within ±10 %.
    Measurement Point 2 27
    - Reproducibility Test: When identical specimens are measured ten
    (cycle) Point 3 0
    times simultaneously, the within-run cv is below 5.0%.
    Point 4 10
    - Measuring range: Linearity up to 600 mg/dL was obtained by
    Calibration type Linear
    evaluation with control serum of known concentration.
    Unit mg/dL
    Correlation test
    Same measuring principle
    12. HANDLING, USAGE & DISPOSAL
    Serum
    Handling
    Regression equation Y = 0.9987X+0.5337 (n=60)
    1. Specimen can be potentially positive for infectious agents
    Correlation coefficient R = 0.9997
    including hepatitis B virus and HIV. Wear glove and goggle when
    Urine
    needed.2. In case reagents got into skin, eye or mouth by mistake,
    Regression equation Y = 1.0069X－0.5498 (n=60)
    wash it immediately with plenty of water and consult the doctor if
    Correlation coefficient R = 0.9997
    needed.
    (Y: value obtained from using UMA reagent)
    3. If reagents are spilled, dilute with water and wipe it out. If
    9. EXPECTED VALUES
    specimen is spilled, spray 80% of alcohol over the specimen and
    Normal reference range
    wipe it out.
    - 70 – 109 mg/dL (3,9 – 6,0 mmol/L)
    Usage
    Reference range should be established at each facility and
    1. Store reagents under specified condition. Do not use after
    judgement should base on measurement results in a
    expiration date.
    comprehensive manner together with clinical symptoms and other
    2. Do not use the container and auxiliaries included in this kit for
    measurement results.
    other purposes.
    10. INTERFERENCES 3. Do not mix reagents of different lot for use.
    - Not available for common interferences 4. Do not add to the reagent being used even if it is the same lot
    - Do not use hemolytic sample number.
    Disposal
    11. INFORMATION FOR AUTOANALYZERS
    1. All specimens, as well as all instruments (e.g. test tubes) that
     For Hitachi Analyzers
    come in contact with the specimens, must be treated by the
    Calculation Method 2-point (fix)
    following methods, or they must be treated according to the
    Temperature 37 C
    Specimen 2.1 manual for infectious medical waste provided in each facility.

    Volume (μL) R1 210 ・ Sterilize with an autoclave, subjecting them to high pressure
    R2 70 saturated steam at 121 °C for more than 20 minutes. Do not
    Main 570 process waste containing sodium hypochlorite solution with an
    Wavelength (nm)
    Sub- 700 autoclave.
    Point 1 10 ・ Immerse at least one hour in sodium hypochlorite solution
    Measurement
    Point 2 16
    (cycle) (active chloride concentration of over 1000 ppm).
    Point 3 34
    2. This reagent contains sodium azide. Sodium azide can react
    Calibration type Linear
    with lead pipe and/or steel pipe and can generate explosive metal
    Unit mg/dL
    azide. Make sure to use plenty of water at disposal. Concentration
    of sodium azide in R-2 is 0.05%.
     For Beckman Coulter Analyzers

    Calculation Method END 13. OTHER INSTRUCTIONS AND CAUTION

    2/3 Revision 11/2013


    - Results may differ depending on the sample/reagent ratio.
    Adjust parameters for different analyzer.
    - Prepare the calibration curve on the day of determination.

    3/3 Revision 11/2013

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