Wednesday, May 16, 2012

FDA panel supports at-home HIV test, OraQuick

Posted By on Wed, May 16, 2012 at 10:22 AM

An FDA advisory panel just recommended an at-home test kit that can determine an individual's HIV status in twenty minutes with a simple mouth swab. While the test is not as accurate in the hands of nonprofessionals, the panel is hopeful the test will help slow the spread of HIV. The FDA is expected to follow the panel's advice and approve OraQuick for consumer use later this year.

The FDA has approved other at-home testing kits, but this would be the first rapid-response test which informs users of their status in twenty minutes, and which does not require you to send a blood sample to a lab. Orasure has sold a version of OraQuick to health professionals since 2004. The professional kit costs $17.50, but it is unsure how much the kit will sell for over-the-counter.

In the hands of health professionals, OraQuick has been shown to identify carriers from non-carriers 99% of the time. However, a preliminary trial showed that at-home tests only correctly detected HIV carriers 93% of the time. Human error is expected to be responsible for this discrepancy.

Most people agree that this at-home test is a step in the right direction. OraQuick would provide a fast, easy, discreet, and hopefully cheap method of screening yourself, and potential partners, for HIV.

Still, there are two main concerns with making such a test available for private use. The first is that those who use the test may use a negative test result as an excuse to have unprotected sex. This could lead to more unwanted pregnancies, the spread of other STDs, as well as HIV infections in partners who receive a false negative. The other concern is that the test does not come with mandatory counseling.

This comes on the heels of another FDA panel endorsing Truvada as the first drug to be taken by HIV negative individuals who are most at risk for contracting the virus.

Some studies estimate that as many as 240,000 of the 1.2 million people with HIV in the US are not aware of their status. The hope is that this test will reduce the 50,000 new HIV infections a year in the US.

Read more about OraQuick at

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