There are four FDA-approved antibody-only tests. All but one detect IgM and IgG against HIV-1 and HIV-2. Three detect antibodies to both HIV-1 and HIV-2, while the fourth only detects HIV-1 antibodies, and one will pick up Group O.
- Two of these tests are moderate complexity and two are high complexity with run times varying from less than one hour to more than three hours.
- Sample volume can be as small as 15 μL and up to 80 μL.
- Positive results occur approximately 23-25 days following exposure, but the window period per CDC is 90 days. Therefore, a negative test after 90 days is considered to rule out HIV infection from the identified exposure.