FDA approves rapid saliva test for AIDS virus

(Agencies)

Updated: 2004-03-27 09:06

The United States approved the first rapid saliva test for the HIV virus that causes AIDS, health officials said on Friday.

The test, made by OraSure Technologies Inc., provides results within 20 minutes with 99 percent accuracy. Other approved rapid HIV tests require blood samples.

Shares of Bethlehem, Pennsylvania-based OraSure gained $1.55, or 19.02 percent, to close at $9.70 on Nasdaq.

"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.

Officials also said the test, called the OraQuick Rapid HIV-1/2, could help on two fronts, encouraging more people to get tested as well as actually getting them the results.

One-fourth of the roughly 900,000 HIV-infected people in the United States are not aware they have the virus, according to estimates by the Centers for Disease Control and Prevention.

People given standard tests that take a week or two often do not return to get the results. With a rapid test, a patient can get an answer in just one clinic visit. Those who test positive can start treatment quickly and take steps to keep from spreading the virus.

The new saliva test also helps protect health-care workers from becoming infected with HIV because they do not have to handle blood, officials said.

The device could be a valuable tool in fighting the AIDS epidemic in Africa because it is so quick and accurate, Thompson said.

U.S. aid agencies at some point might buy the tests for distribution in Africa, but no plans are yet in place, Thompson said.

The OraSure saliva test is cleared for detecting antibodies to HIV-1, but not for HIV-2, the strain prevalent in parts of Africa. OraSure's 20-minute blood test for HIV is approved for both types.

Only a minority of African patients who test positive for HIV have access to medicines that can suppress the virus.

The Bush administration came under criticism this week from AIDS activists, who accused the government of pushing expensive, brand-name drugs in poor countries over cheaper generics. The administration has said it is concerned that the generics, which often mix several drugs in one pill, may not be safe or completely effective in the long term.

The new test involves wiping a swab along the gums and placing it into a liquid in the testing device. When antibodies to the HIV virus are detected, two reddish-purple lines appear on the device.

Results should be confirmed by a second, more specific test, the Food and Drug Administration said.

At first, the new saliva test will be available only at hospitals and major clinics which are approved to use that type of test. OraSure could apply for a federal waiver to allow more widespread use at health-care facilities.

The saliva tests could eventually be sold without prescription in drug stores, as pregnancy tests are, Thompson said. The test would have to clear several regulatory hurdles first.

Officials would have to consider how patients might react to the results at home, without health-care workers on hand, said Jesse Goodman, director of the FDA's Center for Biologics Evaluation and Research. False positives could be troublesome, he said.

Separately, OraSure said the FDA was requiring additional data before it would clear the company's Uplink Oral Fluid Drug Detection System, a test for cocaine, marijuana and other abused drugs.