UMA CO., LTD.

MEASURE D-Dimer
2-19-6 Yokosuka
Matsudo, Chiba, Japan Reagent for Fibrin Decomposing Material
Latex Immunoturbidimetric Method

　2 ~ 8 °C IVD In vitro Diagnostics Packages

R1 1  60 mL R2 1  20 mL
　DO NOT freeze  24 months/block from light R1 1  45 mL R2 1  15 mL

1. PURPOSE OF USE latex and turbidity increase when coagulation occurs. D-

In vitro determination of D-Dimer in blood serum or blood Dimer in patient samples can be determined by measuring
plasma. the variation of turbidity by spectrophotometer.

2. GENERAL INSTRUCTION 7. STANDARD MEASUREMENT OPERATION

1. For in vitro diagnostics use only. Specimen Calibrator Blank
2. Diagnosis should be made in a comprehensive manner, (S) (Std) (B)
in accordance with other related test results and clinical Specimen (L) 60 - -
symptoms by the doctor in attendance. Calibrator (L) - 60 -
3. For guaranteed results, usage of this product must Saline (L) - - 60
comply with the instruction in this manual. R-1 (L) 1500 1500 1500
4. For automatic analyzers, follow the instruction carefully. Incubate at 37 C in 5 minutes

3. MATERIALS REQUIRED BUT NOT INCLUDED R-2 (L) 500 500 500

- Saline 0.9 % and high grade purified water Mix well; incubate at 37 C for 5 minutes; measure

- Micropipet and other basic laboratory equipment. absorbance at 570 nm/800 nm

- Calibrators and Controls (separatedly sold) Note: See sample preparation for details of specimen

4. REAGENT COMPOSITION & PREPARATION

- Reagent R-1: D-Dimer buffer.
- Reagent R-2: D-Dimer latex solution
- Calibrators & Controls (separatedly sold): Calibrators
(Level 1 – Level 6) and controls (L, H) are ready for use
wthout dilution.
5. SAMPLE PREPARATION & STORAGE
- Use serum or plasma as specimens.
- Collect samples by normal method and determine while
they are fresh. Coagulated agent like EDTA, heparin or
citric acid should be used.
- Analyze sample soon after collection. In case, it could
not be analyzed soon, store samples at -80 ℃ in freezer
and analyze within 1 month (avoid freeze and thaw).
- When using frozen samples, thaw them in room
temperature and determine after mixing it well (transparent
solution) before use.
6. MEASUREMENT PRINCIPLE
D-Dimer in patient samples develops a reaction with anti-
human D-Dimer mouse monoclonal antibody-sensitized
8. CALCULATION & UNIT CONVERSION
Calculation
- Calculate ∆Abs of specimen & standards vs blank
- Plot a calibration curve D-Dimer (µg/mL) = f(∆Abs)
- Calculate D-Dimer in specimen using the curve
(doing same procedure for Controls)
Unit conversion
N/A
9. PERFORMANCE & CORRELATION TEST
Performance
- Sensitivity: When measuring known concentration of
control sera (D-Dimer 0.0 µg/mL and 0.5 µg/mL) for 5
times simultaneously, mean value of 0.5 µg/mL minus 2SD
is mean value of 0.0 µg/mL plus 2SD.
- Specificity: The accuracy is within ±10.0%.
- Reproducibility: CV value < 10.0%.
- Measuring range: 0.5 ~ 50 µg/mL
Correlation test
Company A (same principle)

1/2 Revision 11/2015

 Regression equation: Y = 1.0072X + 1.0291 (n = 67) 3. If reagents are spilled, dilute with water and wipe it out. If
Correlation coefficient: R = 0.994 specimen is spilled, spray 80% of alcohol over the
Company B (same principle) specimen and wipe it out.
Regression equation: Y = 0.9797X + 0.1420 (n = 67) Usage
Correlation coefficient: R = 0.995 1. Store reagents under specified condition. Do not use
(Y: Value obtained from using UMA’s reagent) after expiration date.
- Between Serum and Plasma 2. Do not use the container and auxiliaries included in this
Regression equation: Y = 0.9838X - 0.0113 (n=67) kit for other purposes.
Correlation coefficient: R = 0.999 3. Do not mix reagents of different lot for use.
(Y: Serum; X: Plasma) 4. Do not add to the reagent being used even if it is the
Reference Materials for Calibration same lot number.
- N/A Disposal
1. All specimens, as well as all instruments (e.g. test tubes)
10. EXPECTED VALUES
that come in contact with the specimens, must be treated
- Less than 1.0 µg/mL.
by the following methods:
- Reference range should be established at each facility
・ Sterilize with an autoclave, subjecting them to high
and judgement should base on measurement results in a
pressure saturated steam at 121 °C for more than 20
comprehensive manner together with clinical symptoms
minutes. Do not process waste containing sodium
and other measurement results.
hypochlorite solution with an autoclave.
11. INTERFERENCES
・ Immerse at least one hour in sodium hypochlorite
No influence of free bilirubin upto 18 mg/dL, conjugated
solution (active chloride concentration of over 1000 ppm).
bilirubin upto 21 mg/dL, hemolysis (upto 500 mg/dL),
2. This reagent contains sodium azide. Sodium azide can
formazin turbidity upto 1400 FTU and reumatoic factor
react with lead pipe and/or steel pipe and can generate
upto 550 IU/mL against determination were observed by
explosive metal azide. Make sure to use plenty of water at
internal experiments.
disposal. Concentration of sodium azide in R-2 is 0.05%.
12. INFORMATION FOR AUTOANALYZERS
14. OTHER INSTRUCTIONS AND CAUTION
Calculation Method 2-end point (fix)
- Results may differ depending on the sample/reagent
Temperature 37 C ratio. Adjust parameters for different analyzer.
Specimen 6.0 - Prepare the calibration curve on the day of
Volume (μL) R1 150 determination.
R2 50
Main 570
Wavelength (nm)
Sub- 800
Point 1 10
Measurement
Point 2 18
(cycle) Point 3 34

Calibration type Spline

Unit µg/mL

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.

2/2 Revision 11/2015