FDA 核可OTC 販售愛滋病快篩!!

FDA approves 20 minute take-home HIV test   By Jonathan Fincher  May 16, 2012    One of the biggest problems in fighting the spread of AIDS has always been convincing people to have themselves tested regularly. Unfortunately, getting someone to take a trip to a clinic isn't always easy, particularly in areas where there aren't many options for discrete testing. In a development that could leap right over this privacy hurdle, the U.S. Food and Drug Administration has just unanimously approved an over-the-counter HIV test that enables people to test themselves in their own home and receive results in just 20 minutes.  The company behind the test, Orasure, has been distributing its OraQuick HIV test to doctors and medical facilities since 2004. With the stamp of approval from the FDA though, the same test could be as easy for consumers to obtain and use as a pregnancy test. There have been take-home HIV tests before, but those have involved mailing a blood sample off to a lab and then waiting several days for results.  By approving the test - which uses an easier and faster testing method - the FDA hopes to appeal to a much broader range of potential customers and help people determine whether they are HIV-positive much sooner. With government officials estimating that as much as 240,000 people in the U.S. alone do not realize they are infected, a test like this could be a huge step towards slowing the spread of the disease.  When used by medical professionals, the test has shown to be accurate 99% of the time, but a trial conducted by Orasure found that this accuracy dropped to 93% when used by average consumers. After deliberating with a panel of experts, the FDA decided the benefits of the test far outweighed this drawback. Panelists who spoke with the FDA also stressed the importance of clearly stating on the test's packaging that a negative result does not necessarily mean a person is HIV-free.  Orasure has not revealed how much the OraQuick HIV test will cost once it appears in stores, but the professional version is currently priced at US$17.50. 

Source: Orasure via New York Times