D-Dimer Rapid Test

Product information

The D-Dimer is a rapid screening test for the detection of D-Dimer in citrated plasma and whole blood samples as a tool to assess coagulation disorders by medical healthcare professionals. The determination of D-Dimers only is not sufficient to diagnose deep vein thrombosis nor pulmonary embolism.

Advantages of D-Dimer test

• Easy to perform
• No complex sample collection needed
• Accurate test result

General information

Fibrinogen is one of the main proteins of the blood coagulation system. As a result of the blood coagulation, thrombin is activating fibrinogen into fibrin monomers which are leading to clots formation. Fibrin clots are then digested by plasmin and D-Dimer, which is the main and the smallest component of fibrin clots lysis, is released into the bloodstream.

The presence of D-Dimer in blood samples is an indicator of various coagulation disorders, including deep venous thrombosis (DVT), pulmonary embolism (PE)  and atherosclerosis. D-Dimer assay is a widely used and simple exclusion method of DVT and PE which is, in addition, not requiring any expensive laboratory instruments. In healthy individuals, D-Dimer concentration in blood is less than 400 – 500 ng/mL FEU (FEU: Fibrin Equivalent Unit).

The D-Dimer Rapid Test is a rapid screening test for the detection of D-Dimer in citrated plasma and whole blood samples. As the samples flows through the absorbent device, the anti-D-Dimer immunoglobulins dye conjugate binds to the D-Dimer, forming an antibody-antigen complex.

This complex binds to the specific polyclonal antibodies directed against human D-Dimers in the positive reaction zone and produces a pink-rose colored band, if the D-Dimer concentration in the sample is greater than 400 ng/mL FEU. In case of the concentration level is lower than 400 ng/mL FEU, there is no line in the positive reaction zone.

The reaction mixture continues flowing through the absorbent device, past the reaction and control zones. Unbound conjugate binds to the
reagents in the control zone, producing a pink-rose color band, demonstrating that the reagents are functioning correctly.

Test procedure

1. Allow specimen and D-Dimer Rapid Test to come to room temperature prior to testing.
2. Remove the reaction device from its protective wrapper by tearing along the split.
3. Label device with the patient ‘s name or control number.
4. Fill the plastic pipette with specimen (citrated plasma) and, by holding it vertically, dispense one drop (25 μL) into sample well. If whole blood is used, dispense two drops (50 μL) into the sample well and wait for the whole blood sample to be completely absorbed before adding diluent.
5. Add 5 or 6 drops of diluent (200 μL) in the sample well, with an interval of 2-3 seconds between each drop.
6. Read the results after 10 to 15 minutes. For low positive samples, it is necessary to read the results at 15 minutes.

Interpretation of the results

Negative result: One colored band appears in the control zone. No apparent band in the test zone.

Positive result: In addition to the control band, a clearly distinguishable band also appears in the test zone. D-Dimer concentration is higher than 400 ng/mL FEU.

Invalid result: If there is no distinct colored band visible the control zone, the test is inconclusive for the corresponding parameter. In this case, it is recommended that the test be repeated.