High accuracy One Step D-Dimer Rapid Test, gold colloidal method,quickly and easily , 4mm cassette


Accessories:

Instruction for use, Specimens dilution tube with buffer


Intended Use:


The D-dimer cassette test is a rapid, visual test for the qualitative detection of D-dimer in plasma or whole blood. This kit is intended as an aid in the diagnosis of disseminated intravascular coagulation (DIC), deep venous thrombosis (DVT) and pulmonary embolism. For professional in vitro diagnostic use only.


Summary:


D-dimer testing was originally developed in the diagnosis of disseminated intravascular coagulation (DIC). In the 1990s, it was turned out to be useful in diagnosis of thromboembolic process. D-dimer is a fibrin degradation product, a small protein fragment present in the blood after a blood clot is degraded by fibrinolysis. During coagulation of blood, fibrinogen is metabolized to fibrin by thrombin activation. Fibrin consists of D- and E- units. The cleavage of fibrin leads to so called D-dimers. 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 suspected of thrombotic disorders. While a negative result practically rules out thrombosis, a positive result can indicate thrombosis but does not rule out other potential etiologies. Its main use, therefore, is to exclude thromboembolic disease where the probability is low. D-dimer testing is of clinical use when there is a suspicion of deep venous thrombosis (DVT) or pulmonary embolism (PE). In patients suspected of disseminated intravascular coagulation (DIC), D-dimer testing may aid in the diagnosis.



Test Principle:



The D-dimer cassette test is intended for use in the detection of D-dimer in plasma or whole blood. This information can be used by the physician and the patient for disease management. The D-dimer cassette test has been designed to detect D-dimer in plasma or whole blood through visual interpretation of color development in the test device, which is a sandwich immunoassay. The membrane was precoated with an antibody of D-dimer on the test line region (T). During the test the diluted specimen is allowed to react with a colored conjugate (anti-D-dimer antibody-gold conjugate) which was submitted on the pad inside the test cassette. The mixture then moves on the membrane chromatographically by a capillary action. If D-dimer is present in the specimen, a colored line with a specific antibody-antigen- conjugate complex will form at the test line region (T) of the membrane. This complex consists of a colored anti-D-dimer antibody, D-dimer from the specimen and the antibody immobilized on the membrane at the test line region (T). On the other hand, a colored line will always appear at the control region (C) using another antigen-antibody reaction (with anti-mouse antibodies). This control line serves as a procedural indicator for the proper function of the device. It shows that the test procedure has been correct and membrane wicking has occurred. A distinct color development in the test line region (T) indicates a positive result and absence of a color line in the test line region (T) suggests a negative result.



TEST PROCEDURE


1. Bring the pouched test device to room temperature(15-30℃) prior to testing. Do not open the pouch until ready
to begin testing.
2. Remove the device from the sealed pouch and lay it on a flat and dry surface.
3. Using the provided pipette, add one drop of fresh specimen to the sample well.
4. Hold the buffer bottle vertically and add 1 drop to the sample well. /If using a pipette, change a new one to avoid cross-contamination. Draw and transfer 2-3 drops of buffer to the sample well.
5. Read the result between 15-20minutes. Do not read results after 20 minutes.

Quality Control

An internal procedural control is included in the test. A reddish control line appearing in the control region (C-region) of the membrane indicates proper performance of the test. Good laboratory practice (GMP) recommends the use of external controls for the indication of the proper function of the test






PERFORMANCE CHARACTERISTICS


Sensitivity and Specificity


The D-DIMER Rapid Test Card has been evaluated with a leading commercial D-DIMER EIA test using clinical specimens. The results show that relative to leading EIA test.