The first rapid diagnostic test to simultaneously detect the HIV-1 p24 antigen and antibodies to both HIV-1 and HIV-2 earned Food and Drug Administration approval August 8.
Like other HIV tests, the Alere Determine HIV-1/2 Ag/Ab Combo test can detect antibodies to HIV-1, the most common type of HIV, and HIV-2 in human serum, plasma, or venous and fingerstick blood specimens.
Dr. Karen Midthun
But the new test also can distinguish acute HIV-1 infection from established HIV-1 infection, if the blood specimen is positive for HIV-1 p24 antigen but negative for HIV-1 and HIV-2 antibodies.
The new test could be a crucial tool for identifying HIV-infected individuals who might not be able to be tested in traditional health care settings, said Dr. Karen Midthun, director of the FDA’s Center for Biologics Evaluation and Research, in a statement.
"This test helps diagnose HIV infection at an earlier time in outreach settings, allowing individuals to seek medical care sooner," Dr. Midthun explained.
Orgenics makes the Alere Determine HIV-1/2 Ag/Ab Combo test.