Important note: Information in this article was accurate in 1999. The state of the art may have changed since the publication date.
The Bay Area Reporter - July 9, 1999
Mark Norby
FTC claims that in every case the kits showed a negative result when used on a known HIV-positive person, and that the tests should have shown a positive result. "These tests were given to a number of known HIV-positive individuals and in each case the test failed," FTC press agent Vickie Streitfeld told the Bay Area Reporter.
While Streitfeld was able to confirm the test's apparent failure, she was unable to provide evidence on the number of individuals that were tested, nor was she able -- due to strict FTC public information guidelines -- to comment on when the tests were conducted.
Although Internet ads for these home-use kits may say they are only for sale outside the U.S., American consumers have been able to purchase some of these kits. Some ads state or imply that the kits have been approved by the World Health Organization (WHO) or a similar human services health organization, or that the test kits have been approved by the U.S. Food and Drug Administration (FDA).
The FTC warns consumers that neither the FDA nor WHO approve or license HIV test kits, and that neither organization has yet approved any home-use HIV test kits for use or sale in the U.S. However, the FDA has approved only one HIV test for consumers, called the Home Access Express HIV-1 Test System, for sale in the U.S. It is not a home test like a home pregnancy test, for example, but a system where consumers collect blood samples and send them to a laboratory for analysis, where they are processed through FTC-approved guidelines.
The FTC concludes that reliable HIV testing can be done only through a medical professional or clinic, or through use of the Home Access Express HIV-1 Test System.
For more information, call the FTC consumer info line at 1-877-FTC-HELP.
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