A variety of companies, seeking healthy profits, are hoping that home AIDS tests will someday find their place alongside pregnancy tests in American drugstores.
The home tests will be discussed April 6 in Washington at a public hearing of the federal Food and Drug Administration.Many local health professionals are opposed to the concept.
"I would be surprised - even shocked - to see it (a home test) licensed. It is not a good idea," said Lewis Garrett, AIDS control section manager for the Utah Department of Health.
Garrett said the home test would be an ELISA test. "They have an occasional false-positive. And without a confirmative test, it's unwise to rely on an ELISA alone."
Some manufacturers obviously don't agree. Two years ago several companies came up with an idea that would bring in the bucks and provide complete anonymity to millions of potential victims who fear disclosure and possible discrimination.
A recent survey by the George Washington University showed that while four-fifths of the states provided some degree of anonymous testing, only 10 states provided complete anonymity. The Utah Legislature this year passed a law that requires mandatory reporting to the state Health Department of persons who test positively for AIDS and HIV. The one exception is the Salt Lake County Health Department, which will be able to continue its anonymous testing program.
Unlike pregnancy tests, the AIDS home test kits, to be sold in drugstores and other retail outlets, would require a person to send a sample of his blood to a testing site where it could be analyzed by licensed technicians.
The person would pierce his skin with a lancet provided in the kit and mail the blood sample to the designated testing site. After a week's wait, he would dial a toll-free number, give a number or code corresponding to the sample sent in, and get the results.
The method, company officials say, would be simple and provide complete anonymity.
Thus far, the FDA hasn't agreed and has refused to approve the home test kits. Like Garrett, FDA officials cited concerns about false-positive results. They are also worried about sending possibly dangerous blood samples by mail.
But the biggest concern of the FDA and Garrett is the lack of personal counseling for people who would take the home test. "The biggest problem is that there would be no pre-test or post-test counseling, which is critical," Garrett said.
Personal counseling is mandatory for federally funded AIDS clinics and programs.