Rapid HIV test proposed for at-home use

The test using oral fluid was approved for use in health care settings last year. An OTC option is being met with both hope and hesitation.

By Victoria Stagg Elliott, AMNews staff. Nov. 28, 2005.

When Joseph Inungu, MD, DrPH, wanted to determine his HIV status, he used an over-the-counter home test kit to collect a blood sample and mail it in for laboratory analysis. He then received his results by phone.

"I didn't want to wait in a clinic for something I could do myself," said Dr. Inungu, a professor in the school of health sciences at Central Michigan University.

Now, a proposal by one HIV test manufacturer may make it possible for this testing process to take place entirely at home. No blood would be drawn and no sample would have to be mailed off. Rather, the test would detect HIV antibodies in a sample of oral fluid. And, a patient could get the results within 20 minutes, without talking to anyone.

It's an approach that is being greeted by physicians with both enthusiasm and trepidation.

"It's probably a good idea, but I have mixed feelings," said Jess Fogler, MD, assistant clinical professor in family and community medicine at the University of California, San Francisco. "Traditionally this whole system has been bracketed by pre- and posttest counseling because it's a very charged diagnosis."

OraSure Technologies Inc., which manufactures the rapid test, made a presentation this month to the Food and Drug Administration's Blood Products Advisory Committee to explore the possibility of making it available over the counter for at-home use.

The committee did not make any formal recommendations for or against, although the panel is expected to advise the agency about the kind of research that must be considered before giving it the nod.