PACHA, Congressional Black Caucus, HIV/AIDS Organizations Support Widespread Availability of Rapid HIV Tests

The President's Advisory Council on HIV and AIDS, the Congressional Black Caucus, some House members and almost 100 HIV/AIDS organizations nationwide are urging the FDA to approve rapid HIV tests under a "waived" status under the Clinical Laboratories Improvement Act to allow for widespread availability of the tests, according to an AIDS Healthcare Foundation release. The tests, which can provide results in as soon as 20 minutes compared to one to two weeks with current HIV tests, could not be used or could only be used "on a very limited basis" in 90% of U.S. states if the FDA approves the test with a "moderately complex," instead of a "waived," status under CLIA, according to the release. Rep. Loretta Sanchez (D-Calif.), who supports the "waived" status, said that allowing the tests to be available in public health clinics, in the offices of family doctors and in mobile clinics could "dramatically reduce" the spread of HIV among African Americans and Latinos, who she said are "not likely to seek out testing on their own." Clint Trout, associate director for federal government affairs at the AIDS Healthcare Foundation, said, "The potential for saving lives by using this technology ... is revolutionary," adding, "Only if the tests are widely available to family doctors, emergency rooms and public health testing and counseling programs will they be of any use in curtailing the spread of the epidemic." However, opponents of the "waived" status said that the increased federal oversight with a "moderately complex" status is "necessary to ensure the tests are performed accurately." The FDA is expected to approve the test soon, according to the release (AIDS Healthcare Foundation release, 10/23).