MONDAY, Nov. 11, 2002 (HealthDayNews) -- The U.S. Food and Drug Administration has approved a test for the AIDS virus that can return accurate results within 20 minutes, compared with two weeks for conventional methods.
The test, called OraQuick, uses a plastic stick that, when dipped into a vial of developing fluid and blood, stains red-purple in the presence of HIV. Similar to a pregnancy test, a single line on the stick indicates no virus, while two lines mean there's about a 99.6 percent the person has HIV-1.
If the rapid test is positive, it must be confirmed by an additional blood test. The OraQuick test can also read saliva samples, but the FDA approval does not yet extend to that use.
"Each year, 8,000 HIV-infected people who come to public clinics for HIV testing do not return a week later to receive their test results," Health and Human Services Secretary Tommy Thompson said in a statement. "With this new test, in less than a half an hour they can learn preliminary information about their HIV status, allowing them to get the care they need to slow the progression of their disease and to take precautionary measures to help prevent the spread of this deadly virus."
More than 816,000 Americans have developed AIDS, according to the Centers for Disease Control and Prevention, and nearly 468,000 have died of the infection. Worldwide, some 40 million people have HIV, the agency said.
Roughly 40,000 doctors offices, hospitals, clinics and other facilities are now authorized to perform the test, said Michael Gausling, president of OraSure Technologies, of Bethlehem, Pa., which makes the test. Americans take 17 million HIV tests a year, not including screening of potential blood donors.
Here is the FDA Talk Paper describing the device and its approval. To find out more about testing for HIV infection, visit the Centers for Disease Control and Prevention.
