Important note: Information in this article was accurate in 1999. The state of the art may have changed since the publication date.
Important note: Information in this article was accurate in 1999. The state of the art may have changed since the publication date.
Reuters NewMedia - Thursday November 18, 1999
Only one kit is approved for home use, the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) said in a statement. That is the "Home Access Express HIV-1 Test System," made by Home Access Health Corp.
"The approved HIV test has been carefully reviewed by the FDA to ensure that the test system is capable of yielding accurate, dependable results," Steven Masiello of the FDA's Center for Biologics Evaluation and Research, said in a statement.
"The consumer has no assurance of the reliability or accuracy of the test results from unapproved HIV home test kits."
Many of the kits are sold on the Internet, the FDA said. "The Internet makes it easy for con artists to take advantage of consumers," Dr. Jane Henney, commissioner of the FDA, said in a statement. "Therefore, consumers need to be cautious."
The FTC said it had taken action against the maker of one unapproved kit, Cyberlinx Marketing Inc., and reached a settlement.
"Cyberlinx's egregious conduct threatened the health of those consumers who relied upon the representation that the kits gave accurate results," Jodie Bernstein, director of the FTC's Bureau of Consumer Protection, said in a statement.
"Cyberlinx and its president, Jeffrey S. Stein, have settled FTC charges that their unapproved HIV home test kits gave erroneous results," the FTC added in the statement.
"Under the stipulated final order settling the charges, Cyberlinx and Stein are banned from marketing any HIV home test kits in the future and must pay back the money they received from the sale of their kits," the statement added.
They were banned for life from marketing any HIV home test kit, and must post a bond to the FTC if they want to sell any medical device ever again. Another kit, the Confide HIV Testing Service made by Direct Access Diagnostics, had FDA approval but is no longer on the market.
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