Safety of AIDS Home Test Kits Still Doubted by FDA
Federal health officials Thursday said that they remain skeptical about the “safety and accuracy” of new home testing kits for detecting the AIDS virus and said that the government must be cautious before approving their sale.
Food and Drug Administration Commissioner Frank E. Young, testifying before a House subcommittee, said that a final decision has not been made on the home testing kits. The FDA has rebuffed company requests to market the kits and plans a public hearing on the issue next month.
But some manufacturers charged that the FDA was unfairly blocking their marketing efforts by refusing to review their license applications for the kits. They contended that the kits, by allowing maximum privacy, would encourage testing more people for the virus.
Gathering More Information
Young said that the FDA is gathering more information on the kits and will ask company representatives to address the health agency’s concerns at an April 6 meeting.
“Caution at this time is prudent,” Young said before the House Small Business Committee’s subcommittee on regulations, business opportunities and energy.
Young said that federal officials fear at-home AIDS test results would be unreliable, both because the tests would be performed by untrained people and because some people may not be able to follow the directions accurately. “Nothing can substitute for well-qualified individuals using . . . effective tests,” he said.
Young said that further problems could result when blood samples drawn with the kits were shipped to a laboratory for analysis. Delays in arrival of the sample and exposure to temperature extremes could affect the results, he said.
Could Call Lab
After sending off their blood samples, those tested could call the lab about a week later, identify themselves with a special code number and receive the results.
Critics of the at-home tests said they are concerned that those testing positive would not receive proper counseling. “Patients may quickly interpret positive results as a virtual death warrant,” said Rep. Ron Wyden (D-Ore.), the subcommittee chairman.
“In the hands of the untrained, the unscrupulous and the insensitive, home AIDS testing can inflict considerable human damage,” Wyden said.
Elliot J. Millenson, president of Cross Industry Management of Rockville, Md., complained that the FDA has refused to review license applications for any company developing home testing kits.
‘Feasible to Implement’
“The concept of home testing makes sense,” Millenson said. “It is feasible to implement, and the potential benefits appear to be far greater than potential risks.”
Millenson, whose company has developed a home testing kit, said that professional counseling would be provided to people using the kit. But critics said that the telephone counseling may be inadequate for a disease that is fatal.
Young said the FDA, by adopting a cautious stance on home testing kits, does not intend to discourage people from taking the AIDS virus test. With testing now available at many clinics and other health facilities, “we’re not robbing people of access to tests,” Young said.