INTENDED USE: This test is a single use, rapid device intended for qualitative detection of antibodies to Human Immunodeficiency Virus 1/2 in whole blood, serum or plasma specimens. It is intended for use in medical institution as an aid for the diagnosis and management of patients related to infection with HIV and for screening of blood donors, or blood products as well.

TEST PROCEDURE
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 whole blood/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 sample well.
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℃, then the interpreting time should be properly increased to 30 minutes.