FDA approves rapid oral HIV test
March 27 2004 1:00 AM ET
The first oral test for HIV that gives results in 20 minutes won approval from the Food and Drug Administration Friday, creating a new option for people who want rapid results from an HIV test but don't want to give a blood sample. The test, called OraQuick, was previously approved to screen blood samples for HIV antibodies but now also is approved to identify HIV antibodies in oral fluids. With the new alternative, health workers simply wipe a treated cotton swab along the gums and stick the swab into a special testing device for on-the-spot results. Studies show the rapid oral test is more than 99% accurate, the FDA said. But people who test positive will need an additional laboratory-run test to confirm HIV infection.
OraQuick was hailed when it hit the market in 2002 as a way to dramatically increase the number of people who knew they were infected with HIV. Until then, routine HIV tests took up to two weeks to provide results, and 8,000 people a year who tested positive at public clinics never returned to get the news. The rapid oral test may further expand efforts to get more high-risk people tested--not just because some of them shun blood tests but because needle-free testing also is safer for health workers.
"This oral test provides another important option for people who might be afraid of a blood test," Health and Human Services secretary Tommy Thompson said in announcing the FDA's approval. "It will improve care for these people and improve the public health as well."