Rapid HIV Tests OK'd for Accelerated FDA Approval

From the WebMD Archives

June 15, 2000 (Washington) -- The FDA would be justified in lowering its current approval standards to hurry the OK of a rapid HIV test, a panel of expert agency advisers assured agency reviewers Thursday. If the FDA now acts on this advice, then these tests will need to be only 98% sensitive, rather than 100% sensitive as the FDA currently requires.

Rapid HIV tests can detect the presence of an HIV antibody within 20 minutes. The tests are intended for use in clinical settings, such as emergency rooms, where obtaining the immediate results could be beneficial. In current practice, it usually takes between 24 hours to two weeks to get the test results because the testing primarily is conducted in batches at centralized testing laboratories.

The panel's decision was based primarily on testimony given by health care experts, including members of the CDC, who assured the FDA advisers that these rapid results are needed desperately. At the very least, the delay in getting the results from individual tests needs to be eliminated because an estimated 8,000 HIV-positive individuals each year fail to return for their results, Robert Janssen, MD, director of HIV/AIDS prevention for the CDC, told committee members.

A study soon to be published by the CDC also indicates that rapid detection could significantly decrease HIV transmission if these individuals were informed immediately, Janssen added. That study concluded that HIV-positive people are 60% more likely to use a condom, 36% less likely to have sex, and 10% more likely to only have sex with other HIV-positive individuals, he said.

Other studies have shown that there is a need to provide rapid results for pregnant women at risk of having an HIV infection, testified Nancy Wade, MD, MPH, a member of the New York State Department of Health. These studies have demonstrated that antiviral therapy initiated during labor to previously untreated mothers and/or to neonates during the first 48 hours after birth can reduce the incidence of HIV transmission, she said.

To accommodate the need for rapid HIV tests, the FDA already has reduced the number of patient samples needed to demonstrate the effectiveness of the tests.

The panel's decision was a big deal because it shows that the agency will not hold these tests to an unachievable effectiveness standard as some companies have suggested, Kimber Poffenberger, PhD, a regulatory scientist at the FDA in charge of reviewing HIV-detection tests, tells WebMD. "What we did is we said that we will keep the door open," she says.

But in the long run, it truly might not matter. Several manufacturers are developing tests that -- based on preliminary test results -- appear to be more effective than the standard now being considered by the FDA, Poffenberger says. These tests include the Multispot HIV-1/HIV-2 Test, the Medmira Rapid HIV Test, and the Quix HIV-1/HIV-2 Test.

Will Thursday's action also expedite the approval of these tests? Probably not, admits Poffenberger. The agency will still need about six months to review any test, and as of now, the FDA has yet to receive an application for the approval of any of these tests, she tells WebMD.