U.S. approves new oral HIV swab test

WASHINGTON — On-the-spot testing for the AIDS virus is getting easier: The government has approved the first oral HIV test that gives results in 20 minutes.

Until now, rapid HIV testing required pricking a person's finger to test a spot of blood.

With the new alternative from OraSure Technologies Inc., health workers simply wipe a treated cotton swab along the gums, picking up not saliva but cells lining the mouth.

Just as they do with OraSure's rapid blood test, workers then put the swab into a sticklike testing device. Infection is signaled by the presence of reddish-purple lines that appear in a window on the dipstick-like device.

About one-fourth of the 850,000 to 950,000 Americans living with HIV don't know it, according to the Centers for Disease Control and Prevention.

The rapid blood test was hailed when it won approval in November 2002 as a way to dramatically increase the number of people who know they are infected. 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 — because some people shun blood tests and 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 Thompson said in announcing the Food and Drug Administration's approval on Friday. "It will improve care for these people, and improve the public health as well."

Such testing is crucial not just so patients can seek HIV treatment, but because people who know they're infected usually take steps to prevent transmission to their sexual partners, added CDC's Dr. Dixie Snider.

Just like the rapid blood test, the rapid oral test is more than 99 percent accurate, the FDA said. But people who test positive will need an additional laboratory-run test to confirm HIV infection.

Both tests are called OraQuick.

The new oral test is "physically the same device" as the rapid blood test, but "much simpler to use," said OraSure chief executive Mike Gausling.

Thus, it will sell for the same price, about $8 per test for public health officials and $8 to $20 for other organizations, depending on the number ordered.