The D-Dimer Test Cassette (Whole Blood/Plasma) is based on Fluorescence Immunoassay to
measure D-Dimer in human whole blood or plasma as an aid in the diagnosis of DVT and PE.
【SUMMARY】
D-dimer (or D dimer) is a fibrin degradation product (or FDP), a small protein fragment present
in the blood after a blood clot is degraded by fibrinolysis. Its formation or increase reflects the
activation of coagulation and fibrinolysis system, and its plasma level can represent the
production of thrombin active agent fibrin in vivo. It can be used as an indicator of thrombosis in
the body. The D-dimer content in patients with thrombosis is significantly elevated. 1
In addition, studies have shown that low levels of D-Dimer (0.1-0.5mg/L) are closely related to
the occurrence of cardiovascular diseases, and high levels of D-Dimer may be early exclusion
diagnostic indicators for DVT and PE. 2
【PRINCIPLE】
The D-Dimer Test Cassette (Whole Blood/Plasma) detects D-Dimer based on Fluorescence
Immunoassay. The sample moves through the strip from sample pad to absorbent pad. If the
specimen contains D-Dimer, it attaches to the fluorescent microspheres-conjugated
anti-D-Dimer antibodies. Then the complex will be captured by the capture antibodies coated
on the nitrocellulose membrane (Test line). The concentration of D-Dimer in the sample
correlates with the fluorescence signal intensity captured on the T line. According to the
fluorescence intensity of the test and the standard curve, the concentration of D-Dimer in the
sample can be calculated by
Analyzer to show D-Dimer concentration in specimen.
【REAGENTS】
The test includes anti-D-Dimer antibody coated fluorphores and anti-D-Dimer antibody coated
on the membrane.
【PRECAUTIONS】
1. For professional in vitro diagnostic use only.
2. Do not use after the expiration date indicated on the package. Do not use the test if the foil
pouch is damaged. Do not reuse.
3. Avoid cross-contamination of specimens by using a new specimen collection container for
each specimen obtained.
4. Do not eat, drink or smoke in the area where the specimens and tests are handled. Handle
all specimens as if they contain infectious agents. Observe established precautions against
microbiological hazards throughout the procedure and follow standard procedures for proper
disposal of specimens. Wear protective clothing such as laboratory coats, disposable gloves
and eye protection when specimens are assayed.
5. Do not interchange or mix reagents from different lots.
6. Humidity and temperature can adversely affect results.
7. Used testing materials should be discarded in accordance with local regulations.
8. Read the entire procedure carefully prior to any testing.
9. The D-Dimer Test Cassette should only be used with the analyzer by medical professionals.
【STORAGE AND STABILITY】
1. The kit should be stored at 4-30°C before the expiry date printed on the sealed pouch.
2. The test must remain in the sealed pouch until use.
3. Do not freeze.
4. Care should be taken to protect the components of the kit from contamination. Do not use if
there is evidence of microbial contamination or precipitation. Biological contamination of
dispensing equipment, containers or reagents can lead to false results.
【SPECIMEN COLLECTION AND PREPARATION】
Preparation
Before performing the test, please make sure that all components are brought to room
temperature (15-30 °C). Cold buffer solution or moisture condensation on the membrane can
lead to invalid test results.
Sample Handling
1. Collect the specimen according to standard procedures.
2. Do not leave specimens at room temperature for prolonged periods. Plasma specimens may
be stored at 2-8 °C for up to half-day, for long term storage, specimens should be kept below
-20 °C. Whole blood collected by venipuncture should be stored at 2-8 °C if the test is to be run
within half-day of collection. Do not freeze whole blood specimens. Whole blood collected by
finger stick should be tested immediately.
3. Bring specimens to room temperature prior to testing. Frozen specimens must be
completely thawed and mixed well prior to testing. Avoid repeated freezing and thawing of
specimens.
4. EDTA K2, Heparin sodium, Citrate sodium and Potassium Oxalate can be used as the
anticoagulant for collecting the specimen.
Sample Dilution / Sample Stability
1. The specimen (5μL of plasma/7.5μL of whole blood) can be added directly with the micro
pipette into the buffer.
2. Close the tube and shake the sample by hand vigorously for approximately 10seconds to
mix the sample and dilution buffer
3. Let the diluted sample homogenize for approximately 1 minute.
4. It is best to place the diluted sample on an ice pack and leave the sample at room
temperature for no more than 8 hours.
【MATERIALS】
Materials Provided
• Test Cassettes
• Specimen Collection Tubes with dilution buffer
• ID Card
• Package Insert
Materials Required But Not Provided
• Timer
• Centrifuge
• Fluorescence Immunoassay Analyzer
• Pipette
• Specimen Collection Containers
【DIRECTIONS FOR USE】
Refer to Fluorescence Immunoassay Analyzer User Operation Manual for the complete
instructions for the use of the analyzer. The test should be conducted at room temperature.
Allow the test, specimen and buffer to reach room temperature (15-30 °C) prior to
testing.
1. Turn on the Analyzer power.
2. Take out the ID card and insert it into the ID Card Slot. Choose test mode and/or sample
type according to needs.
3. Remove the test cassette from the sealed foil pouch and use it as soon as possible. Best
results will be obtained if the assay is performed immediately after opening the foil pouch.
4. Place the test on a flat and clean surface.
Plasma: Pipette 5 μL of plasma into the buffer tube; mix the specimen and the buffer well.
Whole blood: Transfer 7.5 μL of whole blood into the buffer tube with pipette; mix the
specimen and the buffer well.
5. Add diluted specimen with a Pipette: Pipette 85 μL of diluted specimen into the
sample well of the test cassette. Start the timer at the same time.
6. Test results should be interpreted at 15 minutes with the use of Fluorescence
Immunoassay Analyzer.
Caution: There are different test modes of the Fluorescence Immunoassay Analyzer. The
difference between them is incubation of the test cassette is outside or inside the analyzer.
Choose test mode accordingly and confirm sample type. Consult the user manual of the
analyzer for detailed operation information.
Operator must consult the Fluorescence Immunoassay Analyzer User Manual prior to use and
become familiar with the processes and quality control procedures.
【INTERPRETATION OF RESULTS】
Results read by Fluorescence Immunoassay Analyzer.
The result of tests for D-Dimer is calculated by Fluorescence Immunoassay Analyzer and
display the result on the screen. For additional information, please refer to the user manual of
Fluorescence Immunoassay Analyzer.
Linearity range of D-Dimer Test is 0.1~10 mg/L.
Reference range:＜0.5 mg/L
