Federal Court Issues Restraining Order To Prevent Sales, Distribution of ‘Discreet’ Home HIV Test Kits
A U.S. District Court in Seattle has granted a request from the Federal Trade Commission and issued a temporary restraining order to prevent the sale and distribution of "defective" home HIV test kits, according to an FTC release. According to FTC, the kits' maker, Seville Marketing of British Columbia, Canada, on two Web sites had advertised the "Discreet" home HIV test kits as producing 99.4% accurate results based on three independent studies. However, CDC studied the test kits and found they were not as accurate as the company claimed on its Web site. Three minutes after performing the test according to the package instructions, 15.4% of the results were inaccurate; after eight minutes, 29.6% of the results were inaccurate; and 59.3% of the tests produced inaccurate results after 15 minutes. The kits gave both false-positive and false-negative results, according to the release. The kits, which cost $29.95, have been available on the Web sites aidshivtest.com and discreettest.com. FTC noted in its complaint that the kits cannot be sold legally in the United States because they are not approved by FDA as a diagnostic tool, according to the release. FTC will seek a permanent ban on sales and advertising of the kits in the United States and a permanent order to seize any kits that are imported. Consumers who have used the kits are advised to see a health professional for another test to determine their HIV status, according to the release (FTC release, 6/1).This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.