The D-dimer Rapid Test Cassette (Whole Blood/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of human D-dimer in whole blood or plasma as an aid in the diagnosis of Disseminated Intravascular Coagulopathy (DIC), deep venous thrombosis (DVT) and pulmonary embolism (PE).
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. It is so named because it contains two cross linked D fragments of the fibrin protein. D-dimer concentration may be determined by a blood test to help diagnose thrombosis. Since its introduction in the 1990s, it has become an
important test performed in patients with suspected thrombotic disorders. While a negative result practically rules out thrombosis, a positive result can indicate thrombosis but does not rule out other potential causes. Its main use, therefore, is to exclude thromboembolic disease where the probability is low. In addition, it is used in the diagnosis of the disorder Disseminated
The D-dimer Rapid Test Cassette (Whole Blood/Plasma) is a simple test that utilizes a combination of anti-D-dimer antibody coated particles and capture reagents to qualitatively detect D-dimer in whole blood or plasma. The minimum detection level is 500ng/mL.
How to use?
Allow the test, specimen, buffer and/or controls to reach room temperature (15-30 °C) prior to testing.
1. Bring the pouch to room temperature before opening it. Remove the test cassette from the sealed pouch and use it within one hour.
2. Place the cassette on a clean and level surface.
For Plasma specimen:
· Hold the dropper vertically and transfer 1 drop of plasma (approximately 25µL) to the specimen area, then add 2 drops of buffer (approximately 80µL), and start the timer. See illustration below.
For Venipuncture Whole Blood specimen:
· Hold the dropper vertically and transfer 1 drop of whole blood (approximately 25µL) to the specimen area, then add 2 drops of buffer (approximately 80µL), and start the timer.
See illustration below.
For Fingerstick Whole Blood specimen:
· To use a capillary tube: Fill the capillary tube and transfer approximately 25µL of fingerstick whole blood specimen to the specimen area of test cassette, then add 2 drops of buffer (approximately 80µL) and start the timer. See illustration below.
3. Wait for the colored line(s) to appear. Read result at 10 minutes. Do not interpret the result after 20 minutes.
Note: It is suggested not to use the buffer, beyond 6 months after opening the vial.
INTERPRETATION OF RESULTS
(Please refer to the illustration above)
POSITIVE:* A colored line in the control line region (C) and the presence of one colored line in the test line region indicate a positive result. This indicates that the concentration of D-dimer is above the minimum detection level.
*NOTE: The intensity of the color in the test line region will vary depending on the concentration of D-dimer, present in the specimen. Therefore, any shade of color in the test line region should be considered positive.
NEGATIVE: One colored line appears in the control line region (C). No line appears in the test line region (T).This indicates that the concentration of D-dimer are below the minimum detection levels.
INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test. If the problem persists, discontinue using the test kit immediately and contact your local distributor.