The US Food and Drug Administration (FDA) has approved the first rapid point-of-care test that detects both HIV-1/2 antibodies and the HIV-1 antigen in human serum, plasma, and venous or fingerstick whole blood specimens.
The Alere Determine HIV-1/2 Ag/Ab combo test, manufactured by Orgenics of Yavne, Israel, is also the first FDA-approved test that independently distinguishes results for HIV-1 p24 antigen and HIV antibodies in a single test.
This test helps diagnose HIV infection by trained professionals in outreach settings, allowing individuals to seek medical care sooner.
Detection of HIV-1 antigen permits earlier monitoring of HIV-1 infection than is possible by testing for HIV-1 antibodies alone.
The combo test can distinguish acute HIV-1 infection from established HIV-1 infection when the blood specimen is positive for HIV-1 p24 antigen but is negative for HIV-1 and HIV-2 antibodies.
The Alere Determine HIV-1/2 Ag/Ab combo test is not intended to screen blood donors.
According to the estimation of the Centers for Disease Control and Prevention, approximately 50,000 people are infected with HIV every year in the US. About 80% of patients get diagnosed from the pool of more than one million HIV patients in the US.