Washington Blade - November 18, 2005
Andrew Keegan

But the Nov. 3 session also included HIV organizations, some of which are concerned about what happens to someone after they test positive at home. Proponents argue that the test, which delivers results in about 20 minutes, would help address the estimated 25 percent of the nearly 1 million people in the U.S. infected with HIV but unaware they are carrying the disease.

OraSure Technologies released OraQuick last year for use by physicians and now wants to expand access to the test.

"There's no doubt that more people are getting test results from rapid HIV tests as opposed to waiting two weeks," said Jessica Frickey, a spokesperson for the Centers for Disease Control & Prevention.

Frickey said the CDC attended the FDA meeting to discuss criteria for at-home testing.

"This is just the beginning," she said, adding no decision was made at the meeting.

Officials with OraSure did not return calls for comment.

Counseling a concern

Gene Copello, executive director of the Washington, D.C.-based AIDS Institute, also attended the conference. He said the test would reach a portion of people who aren't currently getting tested through other outlets.

"We know from many studies that it's important to know your HIV status - for your own health and to reduce transmission of the virus," Copello said.

But he said it's also critical to have counseling available to those who test positive. Currently, people who are tested for HIV must receive the results in person from a health official.

"One of our suggestions is for a 24-hour hotline, seven days a week with licensed counselors," he said. "Another idea is to launch the test in a pilot program in cooperation with health departments and pharmacies that have HIV-trained staff."

OraSure will make counseling available to users of the home test, Ronald Spair, OraSure's executive vice president and chief financial officer, told HealthDay.

In 1997, the FDA approved a home HIV test for consumers. The test requires a user to send in a drop of blood from a finger prick to a lab and wait up to seven days for the results, which are retrieved over the phone using an anonymous identification number. Counseling is also available.

Pre-screen partners?

The possibility of individuals using the test to screen partners before engaging in unprotected sex is also a concern among some HIV agencies.

"Literature with the test must emphasize again and again that people still need to practice safer sex," Copello said. "There is always the danger of STDs and a false negative.

Julie Zawisza, an FDA spokesperson, said given the number of AIDS organizations that attended the meeting, a number of scenarios were discussed, including consumers using the test to screen partners before sex.

"Right now it's all speculation," Zawisza said. "But, we're certainly going to be looking into all comments from the meeting."

Fred Dillon, communications director for the San Francisco AIDS Foundation, said instructions for the test must be clear and counseling must be immediately available for test users.

"We must be sure the test doesn't provide a false sense of security," he said. "Just because you test negative doesn't mean the virus is not in your body - it may be inactive."

Regardless, Dillon said the benefits far outweigh concerns.

"Reducing the barrier to testing is of great importance," he said.

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