UMA CO., LTD.

MEASURE TP
2-19-6 Yokosuka Reagent for measuring Total Protein
Matsudo, Chiba, Japan CuSO4

á 2 ~ 8 °C IVD In vitro Diagnostics Packages

R1 1 ´ 100 mL R2 1 ´ 60 mL
T DO NOT freeze 6 24 months/block from light R1 1 ´ 30 mL R2 1 ´ 18 mL

1. PURPOSE OF USE obtained by measuring absorbance of this generated

In vitro determination of Total Protein in serum or plasma. complex
2+
Protein + Copper Ion (Cu ) ® Chelate Complex (purple)
2. GENERAL INSTRUCTION
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. For automatic analyzers: follow their instructions. R-1 (µL) 750 750 750

3. MATERIALS REQUIRED BUT NOT INCLUDED Incubate at 37 °C in 5 minutes

- Saline 0.9 % and high grade purified water R-2 (µL) 450 450 450

- Micropipet and other basic laboratory equipment.
- Calibrators and Controls (separatedly sold)
4. REAGENT COMPOSITION & PREPARATION
- Reagent R-1: Buffer solution
Reagent R-1 is ready for use
- Reagent R-2: Copper(II) Sulfate Solution
Reagent R-2 is ready for use
- 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: Wait until blood sample completly coagulated.
Take the supernatant to use as specimen.
- Plasma: Treat blood sample by anticoagulant; leave it to
stand for 3 hours or centrifuge at 2000 rpm for 2 minutes;
take the plasma layer (supernatant) and use as specimen.
- Analyze sample soon after collection. In case of storing
sample at 2 ~ 8 °C, analyze within 3 days.
6. MEASUREMENT PRINCIPLE
Protein in the samples binds with copper ion in the
reagents and generates purple complex.
Concentration of total protein in the sample can be
Mix well; incubate at 37 °C for 5 minutes; measure
absorbance at 546/700 nm
Note: See sample preparation for details of specimen
8. CALCULATION & UNIT CONVERSION
Calculation
- Calculate ∆Abs of specimen & standards vs blank
- Plot a calibration curve TP (g/dL) = f(∆Abs)
- Calculate TP concentration in specimen using the curve
(doing same procedure for Controls)
Unit conversion
1 g/dL = 10 g/L
9. PERFORMANCE & CORRELATION TEST
Performance
- Sensitivity: Absorbance when measuring purified water
ranges from 0.25 ~ 0.05 and absorbance when measuring
sample of 4.0 g/dL ranges from 0.08 to 0.4.
- Specificity: The accuracy is within ±10.0%.
- Reproducibility: CV value < 3.0%.
- Measuring range: 0.1 ~ 15.0 g/dL.
10. EXPECTED VALUES
Normal reference range
6.0 ~ 8.3 g/dL
Reference range should be established at each facility and
judgement should base on measurement results in a

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comprehensive manner together with clinical symptoms hypochlorite solution with an autoclave.
and other measurement results. ・Immerse at least one hour in sodium hypochlorite solution
(active chloride concentration of over 1000 ppm).
11. INTERFERENCES 2. This reagent contains sodium azide. Sodium azide can
- No influence can be given to the measurement values by react with lead pipe and/or steel pipe and can generate
Bilirubin up to 20 mg/dL, hemoglobin up to 500mg/dL explosive metal azide. Make sure to use plenty of water at
lipemic sera of 3000 formazin turbidity and Ascorbic Acid disposal. Concentration of sodium azide in R-2 is 0.05%.
up to 50mg/dL.
14. OTHER INSTRUCTIONS AND CAUTION
12. INFORMATION FOR AUTOANALYZERS - Results may differ depending on the sample/reagent
Calculation Method 2-point end (fixed) ratio. Adjust parameters for different analyzer.
Temperature 37 °C - Prepare the calibration curve on the day of
determination.
Specimen 4.0
Volume (μL) R1 150
R2 90
Main 546
Wavelength (nm)
Sub- 700
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
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 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

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