Dengue NS1 Rapid Diagnostic Test Kit

SUMMARY AND EXPLANATION OF THE TEST

Dengue NS1 Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection of dengue virus antigen (Dengue Ag) in human serum ,plasma or whole blood. It is intended to be used as a screening test and as an aid in the diagnosis of infection with Dengue viruses.

QUICK CHECK:

easy to use in simple step, 15 minutes out of results.

RESPONSIVE:

High accuracy and stability, double antigen sandwich assay.

CLEAR RESULTS:

The detection board is divided into two lines, the result is clear and easy to read.

REAGENTS AND MATERIALS PROVIDED

1.Each kit contains 25 test devices, each sealed in a foil pouch with two items inside:
a. One cassette device.
b. One desiccant.

2. 25 x 5 µL mini droppers.

3. Sample Diluent (2 bottles, 5 mL).

4.One package insert (instruction for use).

STORAGE AND SHELF-LIFE

1. Store the test device packaged in sealed foil pouch at 2-30℃(36-86F).Do not freeze.
2. Shelf-life: 24 months from manufacturing date.

ASSAY PROCEDURE

Step 1: Bring the specimen and test components to room temperature if refrigerated or frozen. Once thawed, mix the specimen well prior to assay.

Step 2: When ready to test, open the pouch at the notch and remove device. Place the test device on a clean, flat surface.

Step 3: Be sure to label the device with specimen’s ID number.

Step 4: For whole blood test:

- Apply 2 drop of whole blood (about 80-100 µL) into the sample well.

- Then add 1 drop (about 30-40 µL) of Sample Diluent immediately.

For serum or plasma test:

- Fill the pipette dropper with the specimen.

-  Holding the dropper vertically, dispense 1 drop (about 30-45 µL) of specimen into

the sample well making sure that there are no air bubbles.

-  Then add 1 drop (about 30-40 µL) of Sample Diluent immediately.

Step 5: Set up timer.

Step 6: Results can be read in 15 minutes. Positive results can be visible in as short as 1 minute.

INTERPRETATION OF RESULTS

NEGATIVE RESULT:

If only the C band is present, the absence of any burgundy color in the both test bands (G and M) indicates that no anti- dengue virus antibodies are detected.  The result is negative or non-reactive.

POSITIVE RESULT:

2.1 In addition to the presence of C band, if only G band is developed, indicates for the presence of IgG anti- dengue virus; the result suggests past infection or re-infection of dengue virus.
2.2 In addition to the presence of C band, if only M band is developed, the test indicates for the presence of IgM anti-dengue virus. The result suggests fresh infection of dengue virus.
2.3 In addition to the presence of C band, both G and M bands are developed, indicates for the presence of IgG and IgM anti-dengue virus. The result suggests current infection or secondary infection of dengue virus.
Samples with positive results should be confirmed with alternative testing method(s) and clinical findings before a positive determination is made.

INVALID:

If no C band is developed, the assay is invalid regardless of any burgundy color.