Editorials Urge FDA to Approve OraSure Technologies' Rapid HIV Test for Home Use

An advisory panel of FDA on Thursday is scheduled to review a proposal to make OraSure Technologies' rapid HIV test available for use in the home. After the panel makes a recommendation, OraSure said it likely will formally apply to sell the test over the counter. The test, called the OraQuick Advance Rapid HIV 1/2 Antibody Test, has been proven safe, effective and easy to use and currently is only sold to doctors and clinics. The test requires users to swab their gums and then place the swab in a holder. After 20 minutes, one line appears on the strip if the HIV result is negative, two appear if the result is positive. At-home HIV testing has been debated for the past 18 years, as AIDS advocates and public health officials have feared that making such tests available without counseling might lead people to commit suicide, panic or overwhelm public health clinics (Kaiser Daily HIV/AIDS Report, 10/13). Summaries of two recent editorials on the test appear below.

• Albuquerque Journal: At-home HIV testing is a "no-brainer," and such a test "should be put on shelves across the country," the Journal says. "Home HIV testing for those who are afraid, embarrassed or unwilling to go to a clinic could lead more people to get diagnosed and see[k] treatment," the editorial adds, concluding, "That should be reason enough for the FDA" to approve the test (Albuquerque Journal, 11/1).
  
  
• Orlando Sentinel: OraSure's at-home HIV test "easily could be one of the top innovations of 2005," and "swift FDA approval of the request is in order," a Sentinel editorial says. "The convenience and accuracy of the 20-minute test far outweighs FDA concerns about an absence of medical counseling," the editorial says, adding that "proper warnings" must be included. At-home HIV tests "could be the best weapon yet in the world's fight against AIDS," the editorial concludes (Orlando Sentinel, 11/2).

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