Dengue IgG/IgM (DEN) Rapid Test (Cassette)

• Pipette 
• Instructions for use 
• Buffer

Immunochromatographic assay

The Dengue IgG/IgM Rapid Test (Cassette) is a qualitative test for the detection of dengue virus IgM and IgG antibodies in human serum or plasma. This test is for in-vitro diagnostic use only.

Test Procedure:

1. Bring the pouched test device to room temperature(15-30℃) before 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. sample well.
6. Interpret test results within 10-15 minutes. Do not interpret after 20 minutes. (Caution: The above interpreting time is based on the room temperature range of 15-30°C. If your room temperature is significantly lower than 15°C, the interpreting time should be adequately increased to 30 minutes.)

• IgG Positive: 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.
• IgM Positive: 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.
• Negative: 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
• Invalid: 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 the problem persists, contact your local distributor.)