U.S. Government Considers First Do-It-Yourself HIV Test

On Nov. 3, the Food and Drug Administration's Blood Products Advisory Committee will consider whether to recommend over-the-counter sales of an oral HIV test. The OraQuick Advance HIV test could become the first FDA-approved HIV test consumers can take without the presence of a health care worker or the need to mail a sample to a lab.

Briefing documents posted by FDA on the Internet say home sales of the kits could help diagnose more HIV cases, resulting in earlier treatment, and could encourage testing by people reluctant to test in other settings. However, the documents also acknowledge concerns arising from people learning they are HIV-positive when they are likely alone, without access to health professionals or counselors.

Terje Anderson, executive director of the National Association of People with AIDS, called the test "a step forward. Anything that helps more people learn their status is a good thing." But he said most people would still probably choose to test in a medical setting, and he noted that the test's popularity will be influenced by its price. The test's maker, OraSure Technologies Inc., has not decided its price to consumers. Doctors and clinics currently pay $12-$17 per test kit, said Ron Spair, OraSure's chief financial officer.

Spair said OraSure would work with FDA to create instructions for people who test positive; these will likely include a phone number and a Web site address. Spair said the test is accurate more than 99 percent of the time.

Another home test, made by Home Access Health Corp., is FDA-approved for sale in the United States, but it requires the user to collect a sample and mail it to a lab for testing.

Back to other news for October 28, 2005