The FDA has approved several rapid HIV antibody tests in the United States. Some examples are summarized below. There are 7 FDA-approved, rapid, point-of-care tests that the CDC identifies as suitable for use in clinical and nonclinical settings. Six of these tests detect antibodies to HIV-1 and HIV-2, and one detects antibodies only to HIV-1. These antibody test results are either reactive or nonreactive. Hence, none of the currently used point-of-care antibody tests can differentiate HIV-1 from HIV-2.
- Chembio DPP HIV 1/2 Assay: This IgG-sensitive assay can detect antibodies to HIV-1 and/or HIV-2. This assay can be performed on samples of oral fluid, fingerstick whole blood, venous whole blood, serum, or plasma. This immunochromatographic test utilizes the Dual Path Platform (DPP) and requires 10-15 minutes to perform with blood samples and 25-40 minutes for oral fluid.
- Chembio HIV 1/2 STAT-PAK Assay: This IgG-sensitive assay can detect antibodies to HIV-1 and/or HIV-2. Tests can be performed using fingerstick whole blood, venous whole blood, serum, or plasma samples. This immunochromatographic lateral-flow test requires 15 minutes to perform.
- Chembio SURE CHECK HIV 1/2 Assay: This IgG-sensitive assay can detect antibodies to HIV-1 and/or HIV-2. This test is approved for use with fingerstick whole blood, venous whole blood, serum, or plasma samples. This immunochromatographic lateral-flow test requires 15 minutes to perform.
- INSTI HIV-1/HIV-2 Antibody Test: This IgM/IgG-sensitive assay can detect antibodies to HIV-1 and/or HIV-2. This test is approved for use with fingerstick whole blood, venipuncture whole blood, and plasma samples. This flow-through immunoassay requires only 2 minutes to perform.
- OraQuick ADVANCE Rapid HIV-1/2 Antibody Test: This IgM/IgG-sensitive assay can detect antibodies to HIV-1 and/or HIV-2.] This assay can be performed on samples of oral fluid, fingerstick whole blood, venous whole blood, or plasma. This lateral flow immunoassay requires 20-40 minutes to perform.
- Reveal G4 Rapid HIV-1 Antibody Test: This IgG-sensitive assay can detect antibodies to HIV-1. The following samples are FDA-approved for testing: fingerstick whole blood, venipuncture whole blood, serum, and plasma. This vertical flow immunoassay requires less than 3 minutes to perform.
- Uni-Gold Recombigen HIV-1/2: This IgM/IgG-sensitive assay can detect antibodies to HIV-1 and/or HIV-2. This test is indicated for use with fingerstick whole blood, venous whole blood, serum, or plasma samples. This lateral-flow immunoassay requires 15-20 minutes to perform.
Multiple reports have shown problems with false-negative and false-positive test results with the oral fluid point-of-care test. Single-use, point-of-care rapid antibody tests are less sensitive than laboratory-based antigen-antibody tests for the detection of early HIV.
All positive point-of-care HIV test results are considered to be a presumptive positive test and require further supplemental testing for confirmation of HIV.
Reference
HIV Diagnostic Testing, National HIV Curriculum, November 16, 2025, 1-54.
https://www.hiv.uw.edu/go/screening-diagnosis/diagnostic-testing/core-concept/all
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