WASHINGTON – 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 is already 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. However, concerns have been raised about whether a doctor or counselor should be nearby if 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.
The maker, OraSure Technology of Bethlehem, Pa., has not decided how much it will charge consumers for the kit, said Ron Spair, the company’s chief financial officer. The company sells the kits for between $12 and $17 to clinics and doctors, 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.
To take the test, a person swabs the inside of his mouth, between his cheek and gum, picking up not saliva but cells lining the mouth. The user then inserts the swab into a vial of fluid that comes with the kit. Twenty minutes later, an indicator will light up if the test detects the presence of HIV-1 or HIV-2 antibodies.
Those antibodies become present in the body several weeks after a person acquires HIV; the test will not detect the virus if it was more recently acquired.
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.
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