RAPID HIV TESTS: CDC Urges Quicker FDA Approval
CDC officials called this week for faster FDA approval of new rapid HIV tests that give quick results and could reduce new infections, the Los Angeles Times reports. In a "rare show of discord" between the two federal health agencies, Dr. Bernard Branson, a CDC medical epidemiologist who has researched the rapid tests' potential impact on infection rates, said the FDA is being "overcautious" in its approval, and the holdup is "wasting time and costing lives." According to Branson and AIDS advocates, the rapid results provided by the tests are vital to HIV detection, because many people who are tested fail to return for the results. Fearful of the social stigma associated with HIV/AIDS, about one-quarter of those tested for HIV, or 10,000 people annually, never make a second appointment to learn the outcome; those who are infected go untreated and may spread the disease. But with the new tests, people can receive results minutes after they are tested, rather than waiting for days or weeks, and infected individuals can start "almost immediately" on a treatment regimen. One CDC model estimates that using rapid tests at publicly funded HIV testing sites would allow 700,000 more people each year, including 8,000 who are infected, to learn their HIV status. But Dr. Jay Epstein, director of the FDA's office of blood research, said the approval process is "not a simple thing." Defending the FDA's pace, he said, "We understand there is an unmet need. We agree it would be good to have more [tests] on the market. ... [But] the public needs assurance that the (new tests) will meet standards of accuracy and consistency of manufacturing." In the meantime, he added, clinics may apply "under special circumstances" to use the tests prior to licensing. "We are trying to show flexibility and cooperate with the CDC," Epstein said.
In the Works
The only rapid test currently approved for sale, Abbott Laboratories' SUDS, offers results in 10 minutes, but its accuracy depends largely on the technician's training. New tests under development are more "user-friendly," as they require no equipment and little technical expertise. They also cost less than $2, making them particularly "attractive" to rural clinics, hospital emergency departments, mobile units and developing nations. To garner FDA approval, the test will have to demonstrate a "high level of accuracy," although they will not have to be as effective as the ELISA tests used now by most clinics. Instead, test providers would likely use several rapid tests at once to ensure statistically validated accuracy and to protect against false positives or negatives. AIDS Project Los Angeles Director of Education Lee Klosinski said, "The waiting period is one of the cruelest elements of HIV testing. It is having to endure two weeks of hell. Because of it, people get lost. It is the best reason for expediting this technology" (Cimons, 6/14).