UMA CO., LTD.

MEASURE D-Dimer
2-19-6 Yokosuka Reagent for Fibrin Decomposing Material
Matsudo, Chiba, Japan 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 coagulation occurs. D-Dimer in patient samples can be

In vitro determination of D-Dimer in blood serum or blood determined by measuring the variation of turbidity by
plasma. 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 latex and turbidity increase when
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)
Regression equation: Y = 1.0072X + 1.0291 (n = 67)
Correlation coefficient: R = 0.994

1/2 Revision 11/2015

Company B (same principle) Usage
Regression equation: Y = 0.9797X + 0.1420 (n = 67) 1. Store reagents under specified condition. Do not use
Correlation coefficient: R = 0.995 after expiration date.
(Y: Value obtained from using UMA’s reagent) 2. Do not use the container and auxiliaries included in this
- Between Serum and Plasma kit for other purposes.
Regression equation: Y = 0.9838X - 0.0113 (n=67) 3. Do not mix reagents of different lot for use.
Correlation coefficient: R = 0.999 4. Do not add to the reagent being used even if it is the
(Y: Serum; X: Plasma) same lot number.
Reference Materials for Calibration Disposal
- N/A 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 by

- Less than 1.0 µg/mL. the following methods:

- Reference range should be established at each facility ・ Sterilize with an autoclave, subjecting them to high
pressure saturated steam at 121 °C for more than 20
and judgement should base on measurement results in a
comprehensive manner together with clinical symptoms minutes. Do not process waste containing sodium

and other measurement results. hypochlorite solution with an autoclave.

・Immerse at least one hour in sodium hypochlorite solution
11. INTERFERENCES
(active chloride concentration of over 1000 ppm).
No influence of free bilirubin upto 18 mg/dL, conjugated
2. This reagent contains sodium azide. Sodium azide can
bilirubin upto 21 mg/dL, hemolysis (upto 500 mg/dL),
react with lead pipe and/or steel pipe and can generate
formazin turbidity upto 1400 FTU and reumatoic factor upto
explosive metal azide. Make sure to use plenty of water at
550 IU/mL against determination were observed by internal
disposal. Concentration of sodium azide in R-2 is 0.05%.
experiments.
14. OTHER INSTRUCTIONS AND CAUTION
12. INFORMATION FOR AUTOANALYZERS
- Results may differ depending on the sample/reagent
Calculation Method 2-end point (fix)
ratio. Adjust parameters for different analyzer.
Temperature 37 C - Prepare the calibration curve on the day of
Specimen 6.0 determination.
Volume (μL) R1 150
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.
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.

2/2 Revision 11/2015