FDA Okays Home HIV Test

The Food and Drug Administration approved a kit for at-home HIV test after decades of controversy. Bu using this, a person can get preliminary results in less than 30 minutes.

This new HIV test one of its kind is the first one that helps the Americans to detect whether or not they are victims of HIV, a disease that is considered as a shame by many. This test is easy to use like the home pregnancy detector.

OraSue Technologies have come up with OraQuick test, that uses a mouth swab to detect the disease and gives you result in 20 to 40 minutes. This new test is very different from that one that previously existed, where the person had to prick a finger and mail a drop of dried blood to a lab.  OraQuick, will hit supermarkets and pharmacies by early October.

This test would be limited to people above 17 years and buying this demands for identity proof.

This new step is defined as a "positive step forward" by Dr. Anthony S. Fauci, the long-time AIDS researcher and director of the National Institute of Allergy and Infectious Diseases. He believes this new test could bring the 30 year old epidemic under control.

Tests for the human immunodeficiency virus, which causes AIDS, have become increasingly simpler and quicker to use since their introduction in the 1980s. In 2002, the FDA approved the first on-the-spot tests for clinics. In 2005, the FDA began exploring the possibility of approving a home test.

The FDS emphasizes that the antibodies that is being detected in the swab from the gums should not be the final result.  When observed this new test failed to detect HIV in 1 in every 12 patients known to be infected, and returned false positives in 1 in 5,000 cases.  The agency makes it clear that people receiving positive result should follow up with a medical provider. 

It is estimated that about 240,000 people, of the 1.2 million HIV carriers in the U.S. are not aware they are infected.

FDA stressed in its approval announcement that the test is not 100 percent accurate. A trial conducted by Orasure showed the home test only correctly detected HIV in those carrying the virus 92 percent of the time. That means that the test could miss one person for every 12 HIV-infected people who use the kit.

The agency said it hoped the new tests would reach people who were not getting tested, which, in turn, could lead to early treatment and reduce the transmission rate of the virus.

It is believed that this home test will b available in more than 30,000 pharmacies and the cost at which it be sold is not yet decided though it will be more than $ 17.50.

Chip Lewis, a spokesman for Whitman-Walker Health, which provides AIDS care in Washington, said, "At-home testing could reach some people who didn't want to go to a clinic. But removing medical professionals from the process could cause problems. It's not like a home pregnancy test. You need really a lot of information about how to read the test, how to use the test properly."