The US Food and Drug Administration (FDA) announced on Tuesday that is has approved the first over the counter HIV test kit that allows Americans to test, in the privacy of their own homes, whether they are infected with the virus that causes AIDS.

The OraQuick In-Home HIV Test detects the presence of antibodies to human immunodeficiency virus type 1 (HIV-1) and type 2 (HIV-2). It is the first rapid diagnostic test for any infectious disease that the FDA has approved for sale over the counter.

The kit, from OraSure Technologies of Bethlehem, Pennsylvania, is an over the counter version of a test used by trained technicians in clinical settings that the FDA approved in 2004.
The user takes an oral swab, and places it in a specially prepared vial that comes with the kit. The result is ready in 20 to 40 minutes.

The kit is not as reliable as getting tested by a trained clinician. A positive result does not necessarily mean that the user is definitely infected with HIV, but that they should then go and get themselves tested in a medical setting to confirm the result.
Similarly, a negative result does not necessarily mean the user is definitely not infected: particularly if they may have picked up the virus in the previous three months.

Based on clinical studies, the kit is expected to show one false positive out of every 50,000 results and one false negative out of every 12 results. The idea is not for the home test kit to replace medical testing, but to provide another route for people to find out their HIV status. Karen Midthun, director of the FDA?s Center for Biologics Evaluation and Research, told the press:

?Knowing your status is an important factor in the effort to prevent the spread of HIV.? The availability of a home-use HIV test kit provides another option for individuals to get tested so that they can seek medical care, if appropriate,? she added.

Source : Medical News Today



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