Rapid HIV test approved for HIV type 2
June 24 2004 12:00 AM ET
OraSure Technologies, the maker of the OraQuick Rapid HIV Antibody Test, announced Wednesday that the company has received Food and Drug Administration approval to use the rapid test to screen for HIV type 2. The test has already been approved to test for type 1 of the virus, the subtype most common in North America and Europe. HIV-2 is rare in the United States but is the predominant form of the virus in West Africa. The new approval makes the test the world's only HIV antibody test that can screen for HIV-2 and HIV-2 in oral fluids, plasma samples, blood from finger-stick tests, and blood drawn intravenously. The test can produce results in about 20 minutes. OraSure is now seeking a Clinical Laboratory Improvements Amendment of 1988 (CLIA) waiver from the federal government that will allow the test to be given in nonclinical settings, including street outreach programs and at AIDS service organizations.