Path to OTC status laid out for HIV test

Physicians worry that patients wouldn't get needed counseling, but the test maker promises to work with the medical community.

By Victoria Stagg Elliott — Posted April 17, 2006

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The rapid HIV test is one step closer to being made available over the counter.

The Food and Drug Administration's Blood Products Advisory Committee last month endorsed a proposed plan for studies needed to determine if allowing this move will be safe and effective. These studies will identify potential users and assess if this population can, with only the kit's accompanying instructions, use the test, interpret results and access the medical system, as appropriate, without the involvement of a health care professional.

"We are extremely encouraged by the proposal put forward by the FDA and the endorsement of the proposal by the committee," said Douglas A. Michels, president and CEO of OraSure Technologies, the test's manufacturer.

This possible shift of HIV testing from the health care setting has been greeted with general discomfort in the medical community. Most doctors would like to see the rapid test become more available but are concerned that making it obtainable over the counter will disengage it from pre- and post-test counseling. There are also concerns about getting people linked to care, if needed. For example, the AMA supports increased use of this test but opposes approval for a home version unless it is tied to proper laboratory evaluation and counseling services.

OraSure officials pledged to create print materials and run telephone counseling services that would facilitate the contacts that will help address patient needs. The company also intends to create educational programs for physicians to ensure medical personnel know how to respond to patients bringing in these test results.

"We're going to establish multiple ways for a consumer to get connected to care and counseling," Michels said. "And we intend to include the physician community in our plans to make sure that they are aware of the product, how the product is being marketed to the consumer and where and how we're trying to direct potential users. This will be a very collaborative and cooperative effort with the health care community."

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External links

Briefing materials, including information on over-the-counter HIV tests, from the Food and Drug Administration Blood Products Advisory Committee's March 9-10 meeting (link)

"Consolidation of AMA House Policies on HIV/AIDS" AMA Council on Scientific Affairs, 2003 (link)

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