October 2, 2002
AIDS advocacy groups have accused the Food and Drug Administration of dragging its feet while reviewing tests that proved extremely accurate and are used in 90 other countries. Test proponents say the delays have endangered the public's health because nearly a third of those who test positive for HIV each year never return to find out their results, which can take as long as two weeks to process.
FDA officials declined to comment on their timeline. The agency granted preliminary approval in May to two rapid HIV tests, pending inspections of manufacturing plants and approval for the products' labeling. It is not clear when the approval announcement will be made but some people familiar with the process say it could come within the next two weeks.
The first test slated to be approved is OraQuick, manufactured by OraSure Technologies of Bethlehem, Pa. When the test detects the presence of HIV antibodies, it displays two red bars on a small strip enclosed in plastic. The device is designed for just one use, and the company has not disclosed its price. The standard test for HIV, ELISA, takes a minimum of five hours to process, and sometimes as long as overnight. But because the test often is sent to labs -- where it is run in batches -- results often are not available for days or even weeks. Both with ELISA and the new rapid test, a person may be infected for several months before producing enough HIV antibodies to show a positive result.
Since 1993, Abbott Diagnostics has sold a test that can provide HIV results in 20 minutes. Advocates and public health experts, however, say the test is not very useful because it requires cold storage before use and is labor-intensive to perform. Abbott has not sought FDA approval of its easier-to-use rapid test Determine, which is manufactured and widely used outside the United States.