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UMA CO., LTD.

MEASURE ALB
2-19-6 Yokosuka Reagent for determination of Albumin
Matsudo, Chiba, Japan Bromocresol Green Method

á 2 ~ 8 °C IVD In vitro Diagnostics Packages


R1 2 ´ 90 mL
T DO NOT freeze 6 24 months/block from light R1 2 ´ 60 mL

1. PURPOSE OF USE absorbance of generated complex.


In vitro determination of Albumin in serum or plasma. Albumin + Bromocresol Green (BCG)

2. GENERAL INSTRUCTION
→ Albumin Bromocresol Green Complex

1. For in vitro diagnostics use only.


7. STANDARD MEASUREMENT OPERATION
2. Diagnosis should be made in a comprehensive manner,
Specimen Calibrator Blank
in accordance with other related test results and clinical
(S) (Std) (B)
symptoms by the doctor in attendance.
Specimen (µL) 20 - -
3. For guaranteed results, usage of this product must
Calibrator (µL) - 20 -
comply with the instruction in this manual.
Saline (µL) - - 20
4. If you use automatic analyzers, follow their instructions
R-1 (µL) 2000 2000 2000
carefully.
Incubate at 37 °C in 5 minutes
3. MATERIALS REQUIRED BUT NOT INCLUDED Mix well; incubate at 37 °C for 5 minutes; measure
- Saline 0.9 % and high grade purified water absorbance at 660/700 nm
- Micropipet and other basic laboratory equipment.
Note: See sample preparation for details of specimen
- Calibrators and Controls (separatedly sold)
8. CALCULATION & UNIT CONVERSION
4. REAGENT COMPOSITION & PREPARATION
Calculation
- Reagent R-1: Bromocresol Green Sodium Salt.
- Calculate ∆Abs of specimen & standards vs blank
Reagent R-1 is ready for use
- Plot a calibration curve Alb = f(∆Abs)
- Calibrators & Controls (separatedly sold): Put 1 mL of
- Calculate Albumin in specimen using the curve
purified water to each vial of calibrators and control; leave at
(doing same procedure for Controls)
room temparature for 30 minutes before use. After
Unit conversion
reconstituted, resulted solutions can be use without dilution.
g/dL = 10 g/L
5. SAMPLE PREPARATION & STORAGE
9. PERFORMANCE & CORRELATION TEST
- Serum: Wait until blood sample completly coagulated.
Performance
Take the supernatant to use as specimen.
- Sensitivity: Change in absorbance when measuring
- Plasma: Treat blood sample by anticoagulant (i.e
purified water ranges from 0.025 to 0.125 and when
heparin lithium); leave it to stand for 3 hours or centrifuge at
measuring samples of 4.0 g/dL ranges from 0.07 to 0.35.
2000 rpm for 2 minutes; take the plasma layer
- Specificity: The accuracy is within ±10.0%.
(supernatant) and use as specimen.
- Reproducibility: CV value < 3.0%.
- Analyze sample soon after collection. In case of storing
- Measuring range: 0.1 ~ 7.0 g/dL.
sample 2~8 °C, analyze within 3 days.
- DO NOT use hemolytic sample. 10. EXPECTED VALUES
- 3.5 to 5.5 g/dL
6. MEASUREMENT PRINCIPLE
Reference range should be established at each facility and
Albumin in patient samples binds with Bromocresol Green
judgement should base on measurement results in a
(BCG) and generates blue complex. Albumin concentration
comprehensive manner together with clinical symptoms
in patient samples can be determined by measuring
and other measurement results.

1/2 Revision 03/2016


11. INTERFERENCES (active chloride concentration of over 1000 ppm).
- Hemoglobin concentration up to 500mg/dL: Not influence 2. This reagent contains sodium azide. Sodium azide can
- Ascorbic acid up to 50 mg/dL: Not influence react with lead pipe and/or steel pipe and can generate
- Bilirubin > 20 mg/dL: Within 0.2 ~ 0.3g/dL explosive metal azide. Make sure to use plenty of water at
- Lipemic sera > 3000 FTU: Within 0.2 ~ 0.3 g/dL disposal. Concentration of sodium azide in R-2 is 0.05%.

12. INFORMATION FOR AUTOANALYZERS 14. OTHER INSTRUCTIONS AND CAUTION


Calculation Method 1-point end - Results may differ depending on the sample/reagent

Temperature 37 °C ratio. Adjust parameters for different analyzer.


- Prepare the calibration curve on the day of
Specimen 2.0
Volume (μL) R1 200 determination.

- -
Main 660
Wavelength (nm)
Sub- 700
Point 1 10
Measurement
Point 2 34
(cycle) Point 3 -

Calibration type Linear


Unit g/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
specimen and wipe it out.
Usage
1. Store reagents under specified condition. Do not use
after expiration date.
2. Do not use the container and auxiliaries included in this
kit for other purposes.
3. Do not mix reagents of different lot for use.
4. Do not add to the reagent being used even if it is the
same lot number.
Disposal
1. All specimens, as well as all instruments (e.g. test tubes)
that come in contact with the specimens, must be treated by
the following methods, or they must be treated according to
the manual for infectious medical waste provided in each
facility.
・ Sterilize with an autoclave, subjecting them to high
pressure saturated steam at 121 °C for more than 20
minutes. Do not process waste containing sodium
hypochlorite solution with an autoclave.
・Immerse at least one hour in sodium hypochlorite solution

2/2 Revision 03/2016

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