Hundreds of HIV test kits sold without FDA approval

NEWARK, N.J. - Hundreds of people used the Internet to buy an HIV home test kit that lacks federal approval and doesn't yield accurate results, authorities said Wednesday.

The online sites selling the Ana-Sal kit claimed it produced results in five minutes that were more than 99 percent accurate.

However, tests by the Food and Drug Administration disproved those claims, Assistant U.S. Attorney Scott Christie said. Neither Christie nor the FDA could say whether the kits, which tested saliva samples, tended to give false positive or false negative results.

The FDA has approved only one home test kit for the virus that causes AIDS: The Home Access Express HIV-1 Test System involves sending blood samples to outside facilities.

Stanley Lapides, 56, pleaded guilty Wednesday to a felony charge of distributing misbranded medical devices with the intent to mislead. He said he mailed 628 kits to U.S. customers from October 1997 to March 1999 without advising them the devices lacked FDA approval.

Christie said the government was attempting to notify the buyers. It wasn't clear how many had been mailed to other countries.

''It's imperative that we at least contact people to let them know they should not rely on them - or shouldn't have relied on them,'' he said.

The Ana-Sal kits are made by Americare Biologicals Inc. of Miami., a subsidiary of Americare Health Scan Inc.

Miyoshi Smith, general counsel of Americare Health Scan, said that the company sent Lapides and others letters over a year ago telling them to stop selling the product in the United States, and also notified the FDA.

She said she was unfamiliar with FDA testing of Ana-Sal but said the product is approved for use in other countries.

The kits sold for $49.95, generating $31,368 in U.S. sales, court papers said. Lapides solicited orders through several now-defunct Web sites, including hivoraltest.com and hivsalivatest.com.

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On the Net:

FDA: http://www.fda.gov/cber/infosheets/hiv-home2.htm