D-dimer Rapid Test
Product Background
D-dimer (or D dimer) is a fifibrin degradation product (or FDP), a small protein fragment present in the blood after a blood clot is degraded by fifibrinolysis. It is so named because it contains two crosslinked D fragments of the fifibrin 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 blood disorder disseminated intravascular coagulation.
Intended use
The D-dimer Rapid Test 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 myocardial infarction (MI).
Operation steps and result interpretation
POSITIVE:* A colored line in the control line region (C) and the presence of one colored lines in the test line regions indicates 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. Insuffiffifficient 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.