HIV 1+2 Test Device Serum/Plasma (Cassette)

• Chasing buffer
• Pipette
• Instructions for use

Immunochromatographic assay

The HIV 1+2 Test Device Serum/Plasma (Cassette) is a single-use, rapid device intended for the qualitative detection of antibodies to Human Immunodeficiency Virus 1/2 in serum or plasma specimens. It is intended for use in medical institutions as an aid for the diagnosis and management of patients related to the infection of HIV and for screening of blood donors or blood products.

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 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 the room temperature range of 15 – 30°C. If your room temperature is significantly lower than 15℃, the interpreting time should be adequately increased to 30 minutes.)

• Negative: The presence of only one line in the control region indicates a negative result.
• HIV-1 Positive: The control line and HIV-1 line (T1) are visible in the result window. The test is positive for HIV-1. 
• HIV-2 Positive: The control line and HIV-2 line (T2) are visible in the result window. The test is positive for HIV-2. 
• HIV-1 and HIV-2 Positive: The control line, HIV-1 (T1), and HIV-2 (T2) lines are visible in the result window. The test is positive for HIV-1and HIV-2. (Regarding a positive result for both HIV-1 and HIV-2 in one patient, the possible reasons are: A) There is the homology in the amino acid sequence of HIV type-1 and type-2. It is possible that the test results simultaneously show positive HIV-1 and HIV-2 in one patient. B) Provisionally, you can conclude virus type according to the line density. If the line density of type-1 is darker than that of type-2 in the result window, you can read as HIV-1 positive. If the line density of type-2 is darker than that of type-1 in the result window, you can read as HIV-2 positive. If you want to determine virus type or co-infection exactly, you should perform the confirmatory assay [e.g., Western blot]).
• Invalid: If the pink color line in the C region is not visible, the result is considered invalid regardless of the presence or absence of the test line(s). (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.)