Pipette, instruction for use, buffer
Principle of Test:
INTENDED USE: Dengue IgG / IgM Rapid Test is a qualitative test for the detection of IgM and IgG antibodies to dengue virus in human serum or plasma. This test is for in-vitro diagnostic use only.
1. Bring the pouched test device to room temperature(15-30℃) prior to testing. Do not open the pouch until ready to perform the assay.
2. Remove the test device from the sealed pouch. Lay it on a flat, clean and dry surface.
3. Use the pipette to draw and slowly add 1 drop of serum/plasma to the sample well.
4. Hold the buffer bottle vertically and add 1-2 drops 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
5. Interpret test results within 10-15 minutes. Do not interpret after 20 minutes.
Caution: The above interpreting time is based on room temperature range of 15 – 30°C. If your room temperature is significantly lower than 15 °C, then the interpreting time should be properly increased to 30 minutes.
INTERPRETATION OF RESULTS
The control line and IgG line (T1) are visible in the result window. The test is positive for IgG antibodies. This indicates a past dengue infection.
The control line and IgM line (T2) are visible in the result window. The test is positive for IgM antibodies. This indicates a primary dengue infection. IgM and IgG Positive:
The control line, IgM (T2)and IgG (T1) lines are visible in the result window. The test is positive for IgM and IgG antibodies. This indicates a secondary dengue infection.
The control line is the only line visible in the result window. No IgG or IgM antibodies have been detected. The result does not exclude dengue infection. If symptoms persist, a new specimen should be drawn from the
patient in 3-5 days and then should be retested
If the control line does not appear in the result window, the test results are INVALID regardless of the presence or absence of the line in the test region.
NOTE: Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for the control line failure. Review the procedure and repeat the test with a new device. If problem persists, please contact your local distributor.