Drug Agency Approves a Quick Test for H.I.V.

By SHERYL GAY STOLBERG

ASHINGTON, Nov. 7 — The Food and Drug Administration approved a test today that can detect whether someone is infected with H.I.V., the virus that causes AIDS, in as little as 20 minutes. Experts said that advance might prompt thousands more Americans to get tested, which in turn might slow the spread of the disease.

The "while you wait" test, by OraSure Technologies Inc. of Bethlehem, Pa., will not be the first rapid H.I.V. test on the market. But, with a 99.6 percent accuracy rate, it is the first one that is highly reliable.

Standard tests for H.I.V. now take two days to two weeks to provide results, a time lag that experts say discourages thousands of people each year from returning to their testing center to find out whether they are infected.

"It's simple, it's accurate and it's very fast," Tommy G. Thompson, the secretary of health and human services, said of the new test.

Mr. Thompson called the agency's action "a very important step in America's war against H.I.V./AIDS."

Public health experts say the test is important for several reasons. It may help reduce mother-to-infant transmission of H.I.V. by enabling doctors to test pregnant women while they are in labor. It will also offer health care workers exposed to H.I.V.-tainted blood a quick way to determine if they need antiviral drugs that could prevent them from getting infected.

In addition, with the Bush administration considering whether to vaccinate all Americans against smallpox, the new test will offer health professionals a fast, easy way to determine if someone is infected with H.I.V., and thus ineligible for the vaccine.

An estimated 900,000 Americans are infected with the human immunodeficiency virus, but as many as a quarter of them do not know it, Mr. Thompson said. Each year, he said, as many as 8,000 people are tested and never return to find out the results.

Federal health officials said the the OraSure test might sharply cut those numbers. Cornelius Baker, executive director of the Whitman-Walker Clinic, a large AIDS healthcare agency in Washington, agreed.

"Right now, people come in for a test and they have to come back two days later to find out the results," Mr. Baker said. "This means we will be able to see more people, because we will be able to give people counseling and a test in one session as opposed to two."

To use the test, a health care worker pricks a patient's finger and draws a single drop of blood, which is dropped into a small vial that contains a liquid solution. The testing device, which resembles a dipstick, is then inserted into the vial.

The test detects whether antibodies to H.I.V. are present in the patient's blood. It takes 20 minutes to an hour to get results, company officials said.

There is, however, one hitch: people infected with H.I.V. do not develop antibodies to the virus until three months after exposure. So the Food and Drug Administration recommends that people who test negative repeat the test if they believe they have been exposed to the virus. The agency also recommends that, in the case of a positive test, a more traditional test be conducted to confirm the results.

The agency has approved the test, called the OraQuick, for use in hospitals, clinics and doctors' offices that meet certain federal laboratory standards.

Because it is so easy to use, Mr. Thompson said, the government may eventually consider making it available more broadly, perhaps even to social workers in H.I.V. counseling centers. Before that happens, however, OraSure must conduct another clinical trial to prove that untrained people can administer the test as reliably as health professionals.

Mike Gausling, the company's chief executive, said OraSure had already submitted a testing proposal to the food and drug agency.

Mr. Gausling said he did not know what the test would cost. But he said it would probably be cheaper than the company's other test for H.I.V., a saliva test that costs about $20. He said it would take about 45 days to get the first 50,000 OraQuick tests to the market.