HIV 1+2 Test Device Whole Blood (Strip)

• Chasing buffer
• Sterile lancet
• Pipette
• Instructions for use

Immunochromatographic assay

The HIV 1+2 Test Device Whole Blood (Strip) is a single-use rapid device intended for the qualitative detection of antibodies to Human Immunodeficiency Virus 1/2 in whole blood, serum, or plasma specimens. It is intended for use in a 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.

Test Procedure:

1. Bring the pouched test strip to room temperature(15-30℃) before testing. Do not open the pouch until ready to perform the assay. 
2. Remove the test strip from the sealed pouch. Lay it on a flat, clean, and dry surface.
3. Hold the dropper vertically and transfer 1 drop of WB/Serum/Plasma to the sample pad of the test strip. Then hold the buffer bottle vertically, add 1 drop, and start the timer.
4. Wait for the red line to appear. Read the result between 10-20 minutes. Do not interpret the result after 20 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 area. The test is positive for HIV-1.
• HIV-2 Positive: The control line and HIV-2 line (T2) are visible in the result area. 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 area. The test is positive for HIV-1 and 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 (Figure 3) 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 strip. If the problem persists, contact your local distributor.)