FDA expected to approve rapid HIV test
BY Advocate.com Editors
October 01 2002 11:00 PM ET
Government analysts expect the Food and Drug Administration to give final approval for a fast-response finger-prick test for HIV antibodies within the next two weeks, the Los Angeles Times reports. In May the FDA awarded preliminary approval to the test, which requires only one drop of blood and can produce results within 20 minutes. Standard HIV antibody tests require blood taken from a vein and can take 10 to 14 days to produce results. The final approval is expected because lingering technical and manufacturing issues cited in May by the FDA have been cleared up, the analysts say.
Health care workers hope to use the quick-turnaround test on people who undergo HIV antibody tests at health clinics but do not return several days later for their results. "The potential for saving lives by using this technology, we think, is revolutionary," said Clint Trout, associate director of federal government affairs for Los Angeles-based AIDS Healthcare Foundation. "We think that the rapid test could be for prevention what protease inhibitors have been for treatment."
Test manufacturer OraSure Technologies also is seeking approval from the FDA to waive requirements that the test results be processed by laboratory technicians, which would allow HIV outreach workers to conduct on-the-street testing in at-risk communities. It's unclear whether the regulatory body will approve that waiver.