Southern California clinical trials of a blood collection kit are sparking an impassioned debate over the issue of home testing for antibodies to the AIDS virus.
The kit is being marketed by USAT Laboratories Inc. of Newbury Park, Calif., which last week began taking out newspaper advertisements seeking participants in the trials. The ads have drawn intense criticism from local AIDS groups, which cite concerns about confidentiality and adequate counseling for people before they take the test and after they receive the results.
"This form of antibody testing can be very dangerous," said Dr. John C. Wolfe, chief executive officer of AIDS Project Los Angeles. "I am very concerned about people being told they are positive over the phone. There is an incredible psychological reaction."
He added: "Is it confidential if you send a check or use a credit card?"
In addition, officials of the Food and Drug Administration and the U.S. Postal Service say they are concerned about the ramifications of widespread mailing of human blood, some of which might be contaminated with the human immunodeficiency virus (HIV) which causes AIDS.
Company officials argue that the mail-in test provides more privacy than a visit to a doctor's office or a blood-testing clinic, at about a third of the cost. In addition, they insist they have taken extraordinary steps to ensure clients' confidentiality and to provide effective counseling to those who test positive.
"The issue is a major one facing this country and we're hoping to offer an alternative to conventional testing services that are now available," said Los Angeles physician Dr. Richard Bank, USAT's medical director. "We're aiming for mainstream America. Mainstream people who want the test and want anonymity and don't want to go to a doctor's office or a testing site."
The FDA said last week that it is reviewing applications by four other companies for permission to conduct trials of home AIDS test kits. In addition, it is investigating reports that several other kits already are being offered for sale to the public.
None of the blood collection kits actually promises test results in the home, unlike, for instance, home test kits for pregnancy and diabetes. Instead, customers must draw a sample of their own blood, seal it in a vial and mail it either to a central company laboratory or to an affiliated blood lab in their area. They get the results seven to 10 days later by phoning a toll-free number and supplying a personal code number.
The kits first came to the FDA's attention in January, 1986, a spokesman said. The agency ruled then that they were new medical devices subject to regulation under the federal Food, Drug and Cosmetic Act Device Amendments of 1976. Regulations are still being developed by the FDA's office of Biologics Research and Review, whose recommendations will go to the Public Health Service for additional study.
A consultant's report presented at a December meeting of the FDA's Blood Products Advisory Committee advised that the home tests should meet a standard known as the four C's: consent, (meaning that the testing is voluntary); confidentiality; confirmation (the use of additional tests to confirm preliminary screening); and counseling.
"The issues are complex--the regulation of counseling with the tests, ensuring confidential results," an FDA spokesman said. "Then, another issue is sending blood through the mails. That's an issue with the Postal Service, to make sure it will be sent properly."
In Canada, health and postal officials have already completed studies of similar home antibody test proposals and ruled that there will be no transport of blood through the mails for such tests.
Meeting the Regulations
"There is heightened concern about shipping blood specimens," a U.S. Postal Service spokesman said last week. "We want to make sure the shipping containers are safe and meet the regulations for packaging of hazardous, restricted or perishable biological materials."
He added that postal officials in Washington are drafting a letter to major health industry groups asking that they confer with the Postal Service on the issue.
To conduct its clinical trials, USAT plans to sell 15,000 to 20,000 of its Safe Check blood collection kits at $40 each. The FDA requires that the trials include 3,000 people considered to be at low risk of acquiring AIDS and 100 from high-risk groups. High-risk groups include homosexuals and bisexuals, intravenous drug users, hemophiliacs and their sexual partners. Following the tests in Southern California, USAT will begin additional studies in the San Francisco area in four to six weeks.
If the USAT kit is approved, an FDA spokesman said, it would still take "a year or so" to reach the market. USAT says it would sell the kit for $50, about one-third of what a private physician or lab would charge.