D-dimer Rapid Test Cassette with High Precise / Accurate
| Product features | Parameters |
| Principle | Chromatographic Immunoassay |
| Format | Cassette |
| Specimen | WB / P |
| Certificate | CE |
| Reading Time | 10 minutes |
| Pack | 10 T |
| Storage Temperature | 2-30°C |
| Shelf Life | 2 Years |
| Sensitivity | 97.20% |
| Specificity | 94.00% |
| Accuracy | 96.40% |
| Cut-Off | 500 ng/mL |
Applications:
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).
Description:
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 Intravascular Coagulopathy.
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.
Order Information
| Cat. No. | Product | Specimen | Pack |
| CDM-402 | D-dimer Rapid Test | WB/S/P | 10T |
