Broader access now available for HIV test
Get ready for wider availability of the OraQuick HIV-1/2 rapid HIV test: with a June 2004 waiver issued by the Food and Drug Administration (FDA), the test now can be used by more than 180,000 sites in the United States, including outreach clinics, community-based organizations, and physicians’ offices.
While the FDA had issued approval for use of the test, manufactured by OraSure Technologies of Bethlehem, PA, on oral fluid samples in March 2004, its application was limited to facilities certified for high-complexity tests. With the CLIA (Clinical Laboratory Improvements Amendments of 1988) waiver in hand, the OraQuick test now can be used in many more health care settings by many different health providers. (Contraceptive Technology Update reported on the FDA approval on oral fluid samples in the article, "FDA approves oral fluid-based test," June 2004, p. 64.)
With the OraQuick diagnostic technology, patients can have a finger prick or a swab of saliva tested, with the results available in about 20 minutes. As with all screening tests for HIV, any reactive test result must be confirmed with an additional specific test.
In making the June announcement, federal officials said that widespread availability of the rapid HIV test may help increase overall HIV testing and decrease the estimated 225,000 Americans who are unaware they are infected with the HIV virus.