FDA to Consider Approving Home Test Kit for HIV
Posted on: Sunday, 30 October 2005, 09:00 CST
By John J. Lumpkin
Swab the inside of your mouth. Put that swab into a vial of test fluid, and 20 minutes later you'll learn whether you're infected with the virus that causes AIDS.
The OraQuick Advance test already is widely available in health clinics and doctors' offices. The Food and Drug Administration is considering permitting it to be sold over the counter.
Supporters of home kits say they will spur more people to get tested and get treatment sooner if infected. But questions have arisen on whether a doctor or counselor should be on hand when people find out they are HIV-positive.
If approved, the test would become the first FDA-approved test that a person can take without the presence of a health care worker or the requirement of mailing a sample to a lab.
Ron Spair, chief financial officer of OraSure Technology, has not decided how much the Bethlehem, Pa., company that makes the kits will charge consumers.
The company sells the kits to clinics and doctors for $12 to $17, he said.
The test is accurate more than 99 percent of the time, Spair said. Still, a positive result from the test should be confirmed through an additional test by doctors or public health officials, he said.
On Nov. 3, FDA's Blood Products Advisory Committee will consider whether to recommend the product for over-the-counter sales. The FDA has the final say; it usually follows the advice of its advisory committees.
Terje Anderson, executive director of the National Association of People with AIDS, called the kits a good idea. He said he doubts they will be as popular as at-home pregnancy test kits, suggesting most people who want an HIV test would prefer to be with a doctor. Their use also may depend on their price.
But the discovery one has HIV is "potentially traumatic," he said.
"There have got to be safeguards built in so they can get all the support they need," he said.
Some companies market unapproved HIV tests for home use; the FDA says it has no information on their reliability.
About 1 million people in the United States are believed to have HIV.
Source: Buffalo News
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