Improving the nation’s response to identifying the nearly 240,000 Americans who don’t know they have HIV and get them into care is a key goal of the National HIV/AIDS Strategy. The FDA has taken another step towards that goal by approving the first rapid test that detects both HIV’s p24 antigen as well as antibodies to HIV-1 and HIV-2.
Taken together, two improvements make the Alere Determine HIV-1/2 Ag/Ab Combo test a notable improvement over current tests. First, this test is not restricted to healthcare workers, so trained professionals in outreach settings such as testing counselors and health outreach workers can utilize this test in their communities. Second, the test can identify HIV much earlier than a traditional antibody-only test.
When testing for antibodies alone, certain tests may not identify HIV until 2 or more weeks after infection, up to 6 weeks. And although this new test can identify the antibodies to both HIV-1 and HIV-2, waiting several weeks after a possible exposure to get tested can cause undue anxiety for individuals. However, by looking for the p24 antigen (a piece of HIV that remains mostly unchanged from person to person), this test can cut down the waiting time after an exposure to 10-12 days.
Since this is a new test, it will likely take some time for it to roll out to healthcare and community outreach settings over the next year. If it’s available, individuals may want to ask their healthcare providers specifically for the test. People should not assume that this test will automatically replace the current inventory of various HIV testing products on the market today.