FDA approves new rapid-test kit for HIV
BY Advocate.com Editors
November 08 2002 1:00 AM ET
Department of Health and Human Services secretary Tommy G. Thompson announced Thursday that the U.S. Food and Drug Administration has approved a new rapid HIV diagnostic test kit that provides results with a reported 99.6% accuracy in as little as 20 minutes.
According to the manufacturer, OraSure Technologies, the OraQuick Rapid HIV-1 Antibody Test uses less than a drop of blood collected to detect antibodies to HIV-1, the virus that causes infection in most cases in the United States. OraSure says that, unlike other antibody tests for HIV, this test can be stored at room temperature, requires no specialized equipment, and may be considered for use outside traditional laboratory or clinical settings.
"Each year 8,000 HIV-infected people who go to public clinics for HIV testing do not return a week later to receive their test results," Thompson said. "With this new test, in less than a half an hour they can learn preliminary information about their HIV status, allowing them to get the care they need to slow the progression of their disease and to take precautionary measures to help prevent the spread of this deadly virus."
The FDA categorizes the OraQuick test as "moderate complexity" under the Clinical Laboratory Improvements Amendments of 1988. Under CLIA, new tests are categorized as either moderate or high complexity. This designation means that the OraQuick test can be given only in CLIA-approved labs by CLIA-certified laboratory technicians or medical staff. If the test manufacturer applies for a CLIA waiver, the FDA can evaluate it for use under less stringent conditions.
"I strongly urge the OraSure company to apply for a CLIA waiver," said Thompson. "If the FDA finds that the company's data proves that the OraQuick test is both easy and safe to use, it can get a CLIA waiver. Then the test could be given in many more health care settings, perhaps even administered by social workers in HIV counseling centers."