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FDA Approves New Rapid HIV Test Delivering Results in 60 Seconds

By Richard Klein

December 3, 2010

Richard Klein, FDA.

Richard Klein, FDA.

Earlier this week the Food and Drug Administration (FDA) announced the approval of the INSTI™ HIV-1 Antibody Test, a new, single use rapid test for the detection of HIV antibodies developed by bioLytical Laboratories of Canada. The newly approved test provides results in as little as 60 seconds, in contrast to the six previously approved rapid HIV tests, which typically deliver results in about 10 - 20 minutes.

The new test contributes to the tools available to us as we work toward the National HIV/AIDS Strategy's goal of increasing the number of people living with HIV who know their serostatus, a critical step in our efforts to curb the spread of HIV/AIDS. Rapid HIV tests allow people to learn their HIV status in a single visit to a testing site, instead of returning days later for results, dramatically increasing the number of people who ultimately learn their serostatus after taking an HIV test.

Rapid testing also helps increase access to HIV testing because testing can be performed outside of the traditional laboratory setting. Individuals who undergo testing can be counseled immediately concerning their HIV status and, if they are positive, given the opportunity to enter medical care.

Read more about FDA's approval of the INSTI™ HIV-1 Antibody Test.

Richard Klein is with the Office of Special Health Issues at the U.S. Food and Drug Administration.

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