FDA considers over-the-counter sales of fast HIV test

ASSOCIATED PRESS

Take a sample of saliva from inside your mouth. Put it into a vial of test fluid, and 20 minutes later you will learn whether you are infected with the virus that causes AIDS.

The OraQuick Advance test is widely available in health clinics and doctors’ offices, and the Food and Drug Administration (FDA) is considering permitting it to be sold over the counter.

Supporters of home kits say they will spur more people to be tested and get treatment sooner if infected. However, concerns have been raised about whether a doctor or counselor should be nearby when people find out they are HIV-positive.

If approved, OraQuick Advance 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 Technologies 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, Mr. 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 the cheek and gum, and inserts the saliva 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 acquired more recently.

Next Thursday, the 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.

The kits are a good idea, said Terje Anderson, executive director of the National Association of People with AIDS. 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 when they are tested. Use of the kits also may depend on their price.

“Overall, I would say they are a step forward,” he said. “Anything that helps more people learn their status is a good thing.”

But the discovery that 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.

The FDA has approved one test, made by Home Access Health Corp., for sale in the United States. People taking this test must collect a sample from themselves and mail it to a lab for examination.

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