USA: Home HIV / AIDS test up for approval by US Food And Drug Administration

Record ID: 402612

  • Title: USA: Home HIV / AIDS test up for approval by US Food And Drug Administration
  • Date: 7th November 2005
  • Summary: (AM) WASHINGTON, DC, UNITED STATES (FILE) (REUTERS) AIDS PATIENT WALKING TO WHITMAN-WALKER AIDS CLINIC AIDS PATIENT GETTING HER BLOOD PRESSURE TAKEN (2 SHOTS)
  • Embargoed: 22nd November 2005 12:00
  • Keywords:
  • Location: Usa
  • Country: USA
  • Topics: Health
  • Reuters ID: LVA4WLP0WF3UN6C3UT948AVP1CUG
  • Story Text: The US food and Drug Administration is considering whether to approve an HIV test currently being used in health clinics, for over the counter use. The approval would mean that for the first time a person could give themselves an HIV test right in their own homes.
    Advocates for home use of the Quick-Response say that it would allow people too shy to walk into a clinic to test for the HIV virus in the privacy of their own homes. "There are still a number of people who don't know their status and there are still a number of people who don't go and get tested. We believe that by making this available over the counter, it will encourage more people to know their HIV status," said Douglas Michels, Chief Executive of Orasure Technologies. The HIV test is similar to a home pregnancy test. One line means negative and two lines, positive. It just takes a swab of saliva and 20 minutes to find out your HIV status. While studies show the test is more than 99 per cent accurate,
    Dr. Philippe Chiliade of the Whitman Walker Clinic says the test could give a false negative result. "There is a window period between a few weeks after infection up to sometimes a couple of months, up to six months, where the test can be negative and in fact a person can be extremely infectious during that period of time, " said Michels. The FDA panel still has concerns about the danger of false positive or false negatives as well has learning the results and not having a counsellor on hand. Tom Donohue of an HIV education group said that the home testing could be a lifesaver for the more than 333 thousand Americans who are unaware they have HIV. "In rural, smaller communities, there's a huge stigma when they go to maybe an AIDS service organisation to go and get tested and risk someone seeing them going there. And people don't want to do that," said Donohue.
    Testing kits that allow consumers to mail a blood sample to a laboratory for results have been approved in the past, but advocates said allowing people to find out their HIV status at home makes testing easier, faster and more private. The FDA panel appeared to support marketing the test to consumers, but said that it would be important to get a second test to confirm the result.
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