Settlement pulls HIV test kits off U.S. market
June 04 2005 12:00 AM ET
A settlement announced by the U.S. Federal Trade Commission this week prevents a Canada-based Internet company from selling HIV antibody test kits to U.S. consumers, the Miami Herald reports. Seville Marketing and Gregory Stephen Wong, both of British Columbia, are ordered not to market Discreet brand HIV antibody test kits to U.S. consumers until the product is approved by the Food and Drug Administration. The product has not been submitted to the FDA for review. Hundreds of the test kits seized earlier this year by the U.S. Customs Service that were intended for delivery to U.S. consumers also will be destroyed, according to the terms of the settlement. Federal officials say the test kits are wildly inaccurate. Kit makers say the test is 99.4% accurate, but U.S. tests showed it failed in 59.3% of the time to produce correct test results for HIV-positive and HIV-negative blood samples.