Dengue NS1 Antigen Rapid Test

INTENDED USE

The Dengue NS1 Antigen Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of dengue virus NS1 antigen in human whole blood, serum, or plasma as an aid in the diagnosis of primary

and secondary Dengue infections.

MATERIALS

Materials Provided

 Individually packed test devices

 Disposable pipettes

 Package insert

Materials Required but Not provided

 Specimen collection container

 Centrifuge

 Micropipette

 Timer

 Lancets

PROCEDURE

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

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

2. 2. Using the provided disposable pipette, transfer 3 drops of specimen (approximately 75 µL) to the specimen well (S) of the device, then start the timer.

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

As the test begins to work, color will migrate across the membrane.

3. 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.

4. INTERPRETATION OF RESULTS
   
   

   POSITIVE: Two colored bands appear on the membrane. One band appears in the control region (C) and another band appears in the test region (T).

   NEGATIVE: Only one colored band appears, in the control region (C). No apparent colored band appears in the test region (T).

   INVALID: Control band fails to appear. Results from any test which has not produced a control band at the specified read time must be discarded. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor.

   NOTE:

   1. A negative result can occur if the quantity of Dengue virus NS1 antigen present in the specimen is below the detection limits of the assay, or the antigens that are detected are not present during the stage of disease in which a sample is collected.
   2. A negative test result cannot exclude a recent infection.
   3. The presence of detectable Dengue virus NS1 Ag may mean positive for early Dengue Infection. As with all diagnostic tests, all results must be considered with other clinical information available to the physician.

   4. LIMITATIONS OF THE TEST

   1.The Dengue NS1 Antigen Rapid Test is for in vitro diagnostic use only. The test should be used for the detection of Dengue NS1 antigen in whole blood, serum or plasma specimens only.

   2.The Dengue NS1 Antigen Rapid Test will only indicate the presence of Dengue NS1 antigen in the specimen and should not be used as the sole criteria for the diagnosis of Dengue.