OraSure Technologies (Bethlehem, Pa.) received Food and Drug Administration (FDA) approval for its OraQuick Rapid HIV-1/2 Antibody Test, an oral HIV test that can give results from saliva samples with over 99% accuracy in 20 minutes. The company has marketed an identical rapid HIV test that uses blood samples since November 2002. The test is expected to help expand AIDS screening tests in the United States and abroad.

To perform the test, a subject wipes the inside of his/her mouth with a swab and then places the sample in a vial of reactant. After 20 minutes, the test shows the presence or absence of antibodies to HIV-1. While the test is approved to detect antibodies to HIV-1 and HIV-2 when used on blood, this approval in oral fluid is limited to detection of antibodies to HIV-1. Patients who test positive must have the results confirmed by an additional, more specific HIV test.

The OraQuick Rapid HIV-1/2 Antibody Test can be stored at room temperature and requires no specialized equipment. It will be available initially in approximately 4,000 certified clinics and hospitals nationwide.