Tests Advertised As "Most Accurate Technology Available" Produced False Results
A California distributor of rapid HIV tests that were advertised on the Internet as being the "most accurate technology available" has settled Federal Trade Commission charges that, in some instances, its tests produced false results. This marks the third settlement the FTC has reached in the past year with marketers and distributors of faulty HIV tests.
The Commission alleged that Sovo Tec Diagnostics, Inc. ("Sovo Tec"), its President, Amhad Shirzadi, and Sovo Tec's General Manager, Deborah Colby, distributed rapid HIV tests under the names, "HIV 1/2 STAT-PAK Ultra Fast" and "HIV 1/2 Whole Blood" that they claimed accurately detected HIV infection in human blood. According to the FTC complaint, in some instances, defendants' HIV tests have not accurately detected the presence of HIV antibodies.
The tests are referred to as "rapid tests," because they provide test results in fifteen minutes or less. Rapid HIV tests use a simple finger prick process for blood collection or a special sponge device for saliva collection. The sample is applied to a plastic testing device and a developing solution, or diluent, is added to determine if the sample is positive for antibodies to HIV. Currently, there are just two rapid HIV tests approved for sale in the U.S. which are only available to medical professionals. Since 1996, U.S. manufacturers have been permitted to export medical devices that are unapproved for sale in the United States, including rapid HIV tests, without Food and Drug Administration (FDA) approval.
The rapid HIV tests Sovo Tec distributed are unapproved for sale in the United States but can be exported.
In November 1999, the FTC settled similar charges against Cyberlinx Marketing, Inc. of Las Vegas, Nevada. Cyberlinx agreed to be banned from marketing any HIV tests and to pay back the money it received from the sale of its tests. According to a warning letter issued by the FDA, Cyberlinx's test were labeled, "HIV 1/2 STAT-PAK Ultra Fast manufactured for Sovo Tec Diagnostics, Inc." In addition, on March 22, 2000, the Commission settled another case against a distributor of rapid HIV tests, David M. Rothbart, President of Medimax, Inc. Finally, on January 13, 2000, the Commission filed a complaint and stipulated preliminary injunction against Alfa Scientific Designs, Inc. of San Diego, California alleging that the company manufactured inaccurate rapid HIV tests. According to the FTC, Alfa Scientific Designs was the supplier of faulty HIV tests to Medimax.
Under the stipulated final order settling the charges, Sovo Tec, Shirzadi, and Colby are prohibited from making false or misleading representations in connection with the advertising or sale of any HIV test, or any other medical device not approved by the U.S. FDA. In addition, the settlement requires the defendants to (1) inform all past purchasers of the FTC settlement; (2) notify the Commission of any complaints or refund requests in the future; and (3) permit the Commission, for a period of five years, to randomly select and test any HIV test or other unapproved device for accuracy.
The Commission vote to approve the stipulated final judgment and order was 5-0, with Commissioners Orson Swindle and Thomas B. Leary issuing separate, concurring statements.
Commissioner Swindle issued a concurring statement strongly supporting this settlement and previous FTC actions that involved allegedly false claims about the accuracy of HIV home use test kits. "Nonetheless," he wrote, "these cases leave unresolved a number of disturbing questions about the export from the United States of potentially faulty HIV tests or test kits. . . . As a practical matter, [the current export regime] permits the export of unapproved HIV tests and test kits without regard to their accuracy." Citing the gravity of AIDS and its devastating impact on the world's population, Commissioner Swindle urged the FDA and Congress to take "a hard look at whether current [U.S.] export laws and practices adequately address the export of devices that, if faulty, may contribute to the spread of AIDS."
Commissioner Leary, in his own separate concurring statement, joined Commissioner Swindle's call for a review of current legislation and regulation governing these exports.
NOTE: A stipulated final judgment and order is for settlement purposes only and does not constitute an admission by the defendant of a law violation. Stipulated orders have the force of law when signed by the judge.
Copies of the Complaint, Stipulated Final Order and the Commissioner's statements are available from the FTC's web site at http://www.ftc.gov and also from the FTC's Consumer Response Center, Room 130, 600 Pennsylvania Avenue, N.W., Washington, D.C. 20580; 877-FTC-HELP (877-382-4357); TDD for the hearing impaired 1-866-653-4261. To find out the latest news as it is announced, call the FTC NewsPhone recording at 202-326-2710.
Claudia Bourne Farrell
Office of Public Affairs
Bureau of Consumer Protection
(FTC File No. 992 3252) (Sovotec)