USA: The U.S. government approves the sale of the first at-home, over-the-counter HIV test - OraQuick. But the makers of the product say it is not meant to replace doctor or clinical tests, but merely supplement them

Record ID: 402407

  • Title: USA: The U.S. government approves the sale of the first at-home, over-the-counter HIV test - OraQuick. But the makers of the product say it is not meant to replace doctor or clinical tests, but merely supplement them
  • Date: 6th July 2012
  • Summary: LOS ANGELES, CALIFORNIA, UNITED STATES (JULY 06, 2012) (REUTERS) AIDE EXPLAINING ORAL HIV TEST WOMAN SWABBING MOUTH WITH HIV TESTER NEW YORK, NEW YORK, UNITED STATES (JULY 05, 2012) (REUTERS) (SOUNDBITE) (English) DOUG MICHELS, ORASURE CEO, SAYING: "We believe that this is another tool in the fight against HIV and AIDS. This doesn't replace testing that goes on in clini
  • Embargoed: 21st July 2012 13:00
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  • Location: Usa
  • Country: USA
  • Topics: Politics
  • Reuters ID: LVA7AMDFM12KFDEMDHCPZ5G3IXAN
  • Story Text: U.S. health regulators have approved an in-home test for HIV, making it the first over-the-counter, self-administered test for the virus that causes AIDS. Called OraQuick, the test provides results in 20 minutes by analyzing an oral fluid sample taken by swabbing the upper and lower gums inside the mouth.
    "We believe that this is another tool in the fight against HIV and AIDS," said Doug Michels, CEO of OraSure Technologies, the manufacturer of the OraQuick test.
    "We believe that this is going to increase people's awareness about HIV and AIDS and we hope it will serve to reduce the stigma that surrounds HIV and AIDS and make testing more normal."
    The OraQuick test is already being used by trained, clinical technicians across the U.S. The home version - which comes with a detailed instructional booklet - includes access to a 24/7 telephone hotline that people can call for support and information.
    Despite the approval, the Food and Drug Administration (FDA) cautioned that a positive result from the OraQuick test does not mean an individual is definitely infected with HIV, but rather that additional testing should be done in a medical setting to confirm the result - a statement supported by OraSure Technologies.
    "This is a screening test and so any positive result is preliminary. It needs to be confirmed by a health care professional and that's clearly explained in the product packaging," said Michels.
    As for health care professionals, the news of the FDA approval was welcomed, but met with caution. Many clinics in the U.S. use a rapid blood test - where blood is taken from a finger prick, then analyzed - instead of the oral swab. One such clinic is AIDS Project Los Angeles, where educational director Vallerie Wagner said that while there are no real cons to at-home, oral testing, she does have some concerns.
    "It's encouraging that people have another tool in their toolbox to actually learn their HIV status, but again that comes with a lot of questions that we have about how this is going to be rolled out and how it will be administered, how people will be guaranteed that the information that they have, or the information that they need, is there at their disposal. Will the people that are there at the other end of the 24-hour hotline actually have all the information that is necessary to be able to give appropriate information to people that are calling in to find out, or to help them in reading the results of their test?"
    Clinical trials for the test showed it was accurate 92 percent of the time in diagnosing people who had HIV -- meaning one out of every 12 test results would be a false negative. False negatives are of particular concern because they could lead HIV-positive individuals to take fewer precautions, raising the danger that they will engage in unprotected sex.
    The test will also not detect HIV within the first 3 months of infection.
    "People can test, but if they've had that high-risk event, then they should test again three months later," said Michels.
    The OraQuick test is scheduled to hit store shelves in October. While the cost has not yet been set, some clinical technicians say to expect a price point somewhere between 20 and 60 dollars.
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