Cleartest light D-Dimer

The CLEARTEST® light D-Dimer Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of human D-Dimer in whole blood or plasma and is used as an aid in the diagnosis of disseminated intravascular coagulopathy (DIC), deep vein thrombosis (DVT) and pulmonary embolism (LE). The detection limit is 500ng/ml. The test is for professional in vitro diagnostic use only.

D-dimer is a fibrin degradation product (FDP), a small protein fragment in the blood after the breakdown of a blood clot by fibrinolysis. The name is derived from the two cross-linked D-fragments of the fibrin protein. The D-dimer concentration is determined by a blood test to help diagnose thrombosis. Since its introduction in the 1990s, it has become an important test in patients with suspected thrombotic disease. While a negative result virtually rules out thrombosis, a positive result may indicate thrombosis but does not rule out other possible causes. The main use of the test is therefore to rule out thromboembolic disease when there is a low probability. It is also used for the diagnosis of disseminated intravascular coagulopathy.

The CLEARTEST® light D-dimer rapid test is a simple test that uses a combination of particles coated with anti-D-dimer antibodies and capture reagents to detect D-dimer.

Performance characteristics

Sensitivity, specificity and accuracy

D-dimer rapid test

• Sensitivity: 97.2 % (95 % CI*: 94.7 % to 98.7 %).
• Specificity: 94.0 % (95 % CI*: 87.4 % to 97.8 %).
• Accuracy: 96.4% (95% CI*: 94.2% to 98.0%).

3 step procedure (sample collection, preparation, testing).

Test evaluation after 10 minutes.

Can be performed with whole blood or plasma.

Store sealed bag at room temperature or refrigerated (2 -30 °C). Do not freeze.