FDA Approves Oral, Rapid-Result HIV Test

WASHINGTON —  The first oral test for the AIDS virus that gives results in 20 minutes won approval from the Food and Drug Administration on Friday, giving a new option to people leery of blood testing.

It’s the second rapid HIV test on the market -- the other requires pricking a person’s finger to test a spot of blood.

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.

Both rapid tests are made by OraSure Technologies Inc.

The rapid blood test 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 is safer for health workers, too.

“This oral test provides another important option for people who might be afraid of a blood test,” Health and Human Services Secretary Tommy G. Thompson said in announcing the FDA’s approval. “It will improve care for these people, and improve the public health as well.”

Studies show the rapid oral test is 99% accurate, the FDA said. But people who test positive will need an additional laboratory-run test to confirm HIV infection.