FTC Halts US Sales of Defective "Discreet" HIV Home Test Kits

FTC News Release
June 1, 2004

A US District Court has issued a Temporary Restraining Order to halt US sales of a HIV/AIDS home test kit. The Federal Trade Commission filed a complaint alleging that the kit's marketer deceptively advertised that its results were 99.4 percent accurate, and was advertising and selling the kits in the United States in violation of federal laws. At the FTC's request, Judge Robert S. Lasnik ordered a temporary bar on the advertising and distribution of the kits in the United States, and ordered that any kits that are imported into the United States be seized. The FTC will seek a permanent ban on the advertising and sale of the defective kits.

According to the FTC complaint, Seville Marketing, Ltd., a British Columbia, Canada, corporation, and its principal, Gregory Stephen Wong, have marketed and sold the "Discreet" HIV home test kit from Web sites aidshivtest.com and discreettest.com. The kits cost $29.95. Advertising on the Web sites makes claims such as "Over the past two years we've had three independent studies done on Discreet and our 99.4% accuracy rate is based upon these studies." On behalf of the FTC, the Centers for Disease Control and Prevention tested the accuracy of the kits. Results of the testing, based on the package instructions, "changed dramatically" during the15 minutes that the results were reported. After three minutes, 15.4 percent of the kits gave erroneous readings; after 8 minutes, 29.6 percent registered inaccurate results; after 15 minutes, 59.3 percent of the kits gave inaccurate results. Moreover, the kits showed both inaccurate HIV-positive results and inaccurate HIV-negative results.

Any consumer who has previously relied upon the results of a Discreet HIV home test kit should see a health professional and take another test to determine his or her HIV status.

In documents filed with the court, the FTC notes that the Discreet kits cannot legally be sold in the United States because the defendants have neither requested nor received approval from the Food and Drug Administration to sell what qualifies as a "diagnostic" instrument under the Federal Food, Drug and Cosmetic Act.

The FTC will seek a permanent ban on the advertising and sales of the kits in the United States. The agency will seek a permanent order to seize any kits that are imported, and it will seek redress for consumers.

This case was brought with the invaluable assistance of Centers for Disease Control and Prevention, the US Food and Drug Administration, and the US Customs and Border Protection.

The Commission vote to file the complaint was 5-0.

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This page was posted on October 10, 2005.

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