Combined Antigen/Antibody
There is only one FDA-approved rapid test that detects both HIV-1 p24 antigen as well as IgM and IgG against HIV-1 and HIV-2. This test can be used with whole blood, serum, or plasma. It has been classified as waived complexity for use with fingerstick whole blood, and moderate complexity for use with venous whole blood, serum, and plasma using 50 μL. It is capable of differentiating HIV-1 from HIV-2.
Self Tests: Antibody
One test has been FDA-approved for use at home. This test detects the presence of IgM and IgG to both HIV-1 and HIV-2 using oral fluid/oral swabs. It takes approximately 20 minutes to perform.
Rapid Point of Care: Antibody
Eight FDA-approved tests are available for the testing of IgM and IgG antibodies. Three are specific for HIV-1 while the others will detect both HIV-1 and HIV-2. Three are waived assays for whole blood use, one is moderate complexity for whole blood, serum, and plasma, and four are waived for fingerstick whole blood while moderate complexity for venous samples. One assay has combined the tests to also detect Treponema pallidum.
Run times are as short as 15 minutes or more than two hours. Sample volumes are small from 2.5 μL to 50 μL. All positive test results are considered presumptive and require follow-up testing.
