NEWARK, N.J. - Hundreds of online shoppers may have unwittingly exchanged privacy for accuracy when they bought an unlicensed HIV home test, say authorities who are trying to find the buyers to warn them about the kit.
The online sites selling the Ana-Sal kit, which lacks federal approval, claimed it produced results in five minutes that were more than 99 percent accurate. But authorities said Wednesday that tests by the Food and Drug Administration disproved those claims.
''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,'' 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.
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.
The FDA has approved only one home test for the virus that causes AIDS: The Home Access Express HIV-1 Test System, which involves submitting blood samples to a laboratory.
At this point, alerting users of the unlicensed test is more important than continuing to respect the Internet buyers' confidentiality, said Riki Jacobs, executive director of the Hyacinth Foundation, an AIDS support organization.
''I think it's a balancing act, and in this case, I'm not sure there's another way,'' Jacobs 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 told Lapides over a year ago 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
