D-dimer Rapid Test Device

A D-dimer Rapid Test Device can assist your healthcare professional in determining whether you could have a blood clotting disorder. Your healthcare practitioner may order further blood tests and/or imaging procedures for you if your blood D-dimer level is high in order to make a diagnosis.

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Products Description

The D-dimer Rapid Test Device (Whole blood/Plasma) detects D-Dimer through visual interpretation of color development in the internal strip. Anti-D-Dimer antibodies are immobilized on the test region of the membrane, and anti-mouse antibodies immobilized on the control region. During testing, the specimen reacts with anti-D-Dimer antibodies conjugated to colored particles and precoated onto the sample pad of the strip. The mixture then migrates through the membrane by capillary action and interacts with reagents on the membrane. If there is sufficient D-Dimer in the specimen, a colored band will form at the test region of the membrane. The presence of this colored band indicates a positive result, while its absence indicates a negative result. The appearance of a colored band at the control region serves as a procedural control, indicating that the proper volume of specimen has been added and membrane
wicking has occurred.

Composition

Materials Provided

 Individually pouched test device

 Package insert

 Dropper

 Buffer

 Desiccant

Materials Required But Not Provided

 Specimen collection container

 Timer

 Centrifuge

Test Procedure

Bring tests, specimens, and/or controls to room temperature (15-30°C) before use.

1. Remove the test from its sealed pouch, and place it on a clean, level surface. For best results the assay should be performed within one hour.

2. Transfer 2 drops of whole blood (approximately 50 µL) or 1 drop of plasma (approximately 25 µL) to the specimen well (S) of the device with the provided dropper, and add 1 drop of buffer (approximately 40 µL). Start the timer.

Avoid trapping air bubbles in the specimen well (S), and do not add any solution to the result area.

3. Wait for the colored band(s) to appear. The result should be read at 10 minutes. Do not interpret the

result after 20 minutes.

The D-dimer Rapid Test (Whole blood/Plasma) has been evaluated with a leading commercial

D-dimer EIA test using clinical specimens. The results show that the sensitivity of the D-dimer Rapid

Test is 98.6%, the specificity is 98.9% and the accuracy is 98.8% relative to the leading EIA test.

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