AEGiS-AP: FDA Warns Against 2 Home HIV Tests

Important note: Information in this article was accurate in 1997. The state of the art may have changed since the publication date.

FDA Warns Against 2 Home HIV Tests

The Associated Press; 50 Rockefeller Plaza, New York, NY 10020 - Friday, September 26, 1997; 4:21 p.m. EDT

WASHINGTON (AP) -- The Food and Drug Administration warned consumers Friday not to use two at-home medical tests for the AIDS virus and hepatitis, saying they were fraudulently sold by a California company.

Neither product -- the "Lei-Home Access HIV Test" and the "In-home Hepatitis A Test Kit" -- has been shown to work, the FDA said.

Anyone who already has used the products should consider being retested, the FDA said. In fact, the agency said it could not be sure that blood samples consumers mailed to the company were checked for the viruses.

"We have no information at this time that any units were actually tested," said FDA compliance officer Steve Masiello. "Anyone who's used a kit from an unapproved source has to question the results."

The kits were sold by Lei-Home Access Care, a division of Jin-Greene Biotechnology Inc. of Sunnyvale, Calif. They were sold largely over the Internet, on a site that claims 100,000 HIV tests were sold in eight months.

But the FDA said some pharmacies also sold them, and urged all pharmacists to remove the unapproved tests from store shelves immediately.

Attempts to locate Jin-Greene were unsuccessful. The company had no listed phone number, and the toll-free number advertised on the Internet was out of service.

The FDA has approved one at-home test kit for the AIDS virus, Home Access Health Corp.'s Home Access HIV-1 Test System. Users prick a finger, smudge a blood spot on a special card identified only by a numerical code, and mail the card to a certified laboratory. The user then calls a hot line, provides the code and learns the test results from a trained counselor.

There is no FDA-approved home test for the liver virus hepatitis A.

The FDA says illegal sales of unapproved HIV tests are a growing problem. In May, the agency posted a warning on its own Internet page reminding consumers that the Home Access Health HIV kit was the only legal and reliable home HIV test.

Copyright 1997/The Associated Press. Reproduced with permission. Reproduction of this article (other than one copy for personal reference) must be cleared through the Permissions Desk, The Associated Press, 50 Rockefeller Plaza, New York, NY 10020.
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