WASHINGTON (AP) -- People who trust unapproved rapid home test kits for AIDS may be risking their lives.
The unapproved kits can give inaccurate results, officials of the Food and Drug Administration and Federal Trade Commission warned today.There is currently only one approved home test kit for the AIDS virus, the agencies stressed. It is the "Home Access Express HIV Test System" made by Home Access Health Corp.
In the Home Access test customers take their own blood sample at home and send it to the laboratory for testing. Results are obtained by telephone using an anonymous personal identification number.
The two agencies said there are other kits being offered for sale, often via the Internet, which promise results at home in 15 minutes using saliva or blood from a finger prick.
These unapproved tests lack laboratory controls and may give inaccurate results, the FDA said.
The FTC also announced that it had reached a settlement with one unapproved kit seller in which the company will stop marketing its product and will turn over to the commission the money it received from customers for the tests.
Cyberlinx and its president, Jeffrey S. Stein, settled charges that they violated federal law by misrepresenting the accuracy of their "EZ MEDTEST" HIV home test kit. FDA said the kits it checked were not reliable.
Under the settlement, Cyberlinx and Stein are banned for life from marketing any home HIV tests and must pay back the money received from sale of the kits. In addition, if Stein or Cyberlinx wish to sell some other medical device they will be required to post a $500,000 bond each.