Regulators Warn Against Self-Administered Hiv Tests

      WASHINGTON - Two federal agencies are cracking down on the illegal sale of unapproved and inaccurate self-administered HIV tests.

      Federal regulators say many unapproved HIV test kits are illegally available to American consumers over the Internet and by direct mail. Only one self-administered HIV test has been approved by the U.S. Food and Drug Administration (FDA).

      The crackdown by the FDA and the Federal Trade Commission (FTC) has produced four lawsuits and more than a dozen warning letters to U.S. makers of the so-called home tests for HIV, the human immunodeficiency virus that causes AIDS.

      ``The consumer has no assurance of the reliability or accuracy of the test results from unapproved HIV home test kits,'' said Steve Masiello, director of the FDA office of compliance and biologics quality.

      Unapproved self-administered test kits have a high risk of producing inaccurate results, often showing the absence of HIV even though the person is in fact infected.

      The FDA prohibits the sale of unapproved HIV tests in the United States and the FTC polices anti-fraud laws governing misleading advertising on U.S.-made products, regardless of where they are purchased. The FDA also enforces some quality control standards for production and packaging of products aimed for the export market, but those manufacturers don''t have to meet the tough ``safe and effective'' test that the FDA requires for drugs and medical devices sold in the United States.

      The relatively lax rules governing HIV test kits manufactured for export have led FTC Commissioner Orson Swindle to question whether U.S. laws ``at least theoretically can contribute to the global threat posed by AIDS.''

      ``International efforts to combat the spread of AIDS are supported by our government, but defective test kits may contribute to the spread of AIDS,'' he said. ``In light of these considerations, should there be a public health mechanism in place in the United States to prevent the export of faulty HIV tests?''

      Since 1997, the FDA has sent letters to more than a dozen companies warning them they had illegally exported test kits because their quality controls were unacceptable or nonexistent. The companies, most of which are based in California and Florida, have exported tests to China, Brazil, Mexico and other countries, according to the agency.

      Some also have illegally sold the unapproved test kits in the United States, under such names as ``EZ MedTest,'' ``HIV 1/2 STAT-PAK Ultra Fast,'' ``Red Dot HIV 1+2 Diagnostic Test Kit'' and ``HBsAG One-Step Test.''

      ``A lot of times, people get into this not realizing it''s prohibited to distribute (the products) domestically,'' said Masiello.

      The sole FDA-approved self-administered HIV test is the Home Access Express HIV-1 Test System, which won FDA approval in 1996. Since then, about 500,000 people have used the kits, according to manufacturer Home Access Health Corp., of Hoffman Estates, Ill.

      The product generally costs about $55 and claims to be 99.9 percent accurate. People using the test collect a blood sample on a coded card, ship the dry sample back to the company and call a toll-free number at least three days later to learn the results.

      By contrast, the most common unapproved test kits promise fast results, like home pregnancy tests, according to Karen Jagielski, a FTC attorney. People using the unapproved test kits are told to put blood or saliva samples on a reactive strip and add a developing solution. A characteristic line or symbol develops, showing the results in about 10 to 15 minutes.

      Since late 1999, the FTC has sued four companies for making false claims about the accuracy of the HIV tests they sold. Three of the cases have been settled:

      -- The FTC last November reached agreement last November with Cyberlinx Marketing, Inc. of Las Vegas, prohibiting Cyberlinx or its president, Jeffrey Stein, from again selling any HIV home test kits.

      -- In March, the FTC won agreement from David Rothbart, who distributed unapproved HIV tests under the company name Medimax, Inc. The Deltona, Fla.-company agreed to stop selling HIV tests.

      -- Last month, the FTC reached a settlement with Novato, Calif.-based Sovo Tec. The company agreed to drop its claim that its screening kits were the ``most accurate technology available.'' The company will continue exporting HIV tests without the claim, said General Manager Deborah Colby, who insisted that the company''s accuracy claim was correct even though individual test kits may fail.

      If any of the firms violate the terms of the settlements, they could be found in contempt of court and might be subject to criminal charges, according to Jagielski.

      A pending case, filed last January in U.S. District Court in San Diego, seeks a court order preventing Alfa Scientific Designs from misrepresenting its tests made for export.

      The lawsuit cites research conducted at the University of Maryland Medical System on the accuracy of Alfa''s HIV tests. There, the tests were administered to 12 known HIV-positive blood samples, but 10 of the tests came out negative.

      One FDA case produced a prison sentence.

      In 1998, Larry Greene of Los Banos, Calif., was sentenced to more than five years in prison after being convicted of selling more than 100 unapproved HIV tests in 1996 and 1997. Greene peddled his kits over the Internet and by phone solicitations to pharmacies in California''s Central Valley.

      Like the FDA-approved Home Access test, Greene''s kits required a small blood sample. However, Greene''s version directed users to place a drop of blood on a Band-Aid attached to a card.

      According to the FDA, people using the kits were advised to send the card to Greene, who had no scientific basis for evaluating them himself. Instead, Greene fabricated the test results, the FDA charged.

      According to the July-August 1999 issue of FDA Consumer Magazine, ``His wife said he could tell whether a person was HIV negative or not by holding the sample up to a light.''

     

c.2000 Hearst Newspapers