The U.S. Food and Drug Administration (FDA) has announced its approval of the first rapid HIV test that can detect both HIV-1 and HIV-2 antibodies as well as a key antigen that indicates a recent infection with HIV-1.  

The test uses samples of finger stick or venous whole blood, plasma or human serum.

Because the HIV-1 p24 antigen appears earlier after infection than HIV antibodies, the Alere Determine HIV-1/2 Ag/Ab Combo assay can accurately diagnose cases that would otherwise produce false negative result with a standard antibody test—thus narrowing the “window period.” The antigen test can also aid in determining whether or not an infection is very recent.

Trained health care professionals can use the test in outreach settings with populations who might not have access to testing in a traditional health care environment.

To read the FDA release, click here.