New Rapid Diagnostic Test for HIV

The test has been cleared by the US Food and Drug Administration (FDA).

Using less than a drop of human blood, the test quickly and reliably detects antibodies to HIV-1, the virus that causes infection in most US cases. Unlike other antibody tests, this test can be stored at room temperature, requires no specialized equipment, and may be considered for use outside traditional laboratory or clinical settings. The test has not yet been approved to screen blood donors. Called the OraQuick Rapid HIV-1 Antibody Test, the test is manufactured by OraSure Technologies, Inc. (Bethlehem, PA, USA).

The FDA currently categorizes the test as of moderate complexity, which means that the test can only be given in laboratories approved by CLIA (Clinical Laboratories Improvements Amendments of 1988) by CLIA-certified laboratory technicians. However, if the manufacturer applies for a CLIA waiver, the FDA can then evaluate the test for use under less stringent conditions. OraSure says it intends to seek a CLIA waiver. The company has begun shipments of the test to Abbott Laboratories (Abbott Park, IL, USA), which is co-marketing the test with OraSure in the United States.

"This test will be a great help in identifying pregnant HIV-infected women going into labor who were not tested during pregnancy so that precautionary steps can be taken to block their newborns from being infected with HIV,” said Dr. Lester M. Crawford, FDA Deputy Commissioner.




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