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."
Thompson said rapid oral testing also could help international efforts to fight HIV in Africa, which is particularly hard-hit by the epidemic.
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.
The CDC is expected to be a prime purchaser; the agency already has bought half a million of OraSure's OraQuick rapid blood tests in the past year.
About 40,000 Americans a year are believed to become infected with HIV, a rate that has held constant for years. Worse, there are disturbing signs that efforts to fight the epidemic are waning, such as recent increases in new HIV cases among gay men.
So last April, the— including a strong emphasis on using rapid tests to screen for HIV in homeless shelters, drug treatment centers, jails and other non-medical settings.
Hospitals also are prime users of rapid HIV tests, using them mostly to tell if health workers were exposed to HIV-infected blood and thus need HIV-blocking medicine. Hospitals also rapid-test women in labor who weren't checked for HIV earlier in pregnancy, so newborns of infected mothers can get anti-HIV drugs in hopes of keeping them virus-free.
Oral HIV testing already is popular with health workers — OraSure has long sold a version that required a laboratory to give results. In about five years, oral testing took over about 30 percent of the traditional HIV testing market, Gausling said.
But it will take OraSure a few more months to be able to sell the rapid version of the oral test outside of hospitals and large health clinics. A law restricts who can use certain types of medical tests, and it will take a waiver of that law to allow the oral test to be sold in the same non-medical settings — like mobile testing vans and homeless shelters — that rapid blood tests already are.
By Lauran Neergaard