Makers of Unapproved Home HIV Test Kits Settle With FTC
Two makers of unapproved home HIV test kits settled with the FTC Tuesday over charges that they "falsely claimed the tests accurately detected [HIV]," the AP/Contra Costa Times reports. The FTC "charged" that the test kits manufactured by Chembio Diagnostic Systems and Alfa Scientific Designs are not always accurate and "sometimes fail to detect the presence of HIV." The FDA never approved the two companies' test kits. The settlement prohibits the two manufacturers from "misrepresenting the accuracy of any medical device," and the companies are required to notify the FTC of any consumer complaints or refund requests associated with the tests. Chembio said in a statement that while the company "disagreed" with the agency's charges, it decided to settle so it could "focus on medical research." Alfa stated that it neither admits nor denies the allegations but remains "committed 'to quality and excellence.'" Since 1999, six marketers of unapproved at-home HIV test kits have been targeted by government regulators (AP/Contra Costa Times, 1/16).This is part of the KHN Morning Briefing, a summary of health policy coverage from major news organizations. Sign up for an email subscription.