Important note: Information in this article was accurate in 1997. The state of the art may have changed since the publication date.
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United Press International; Friday, September 26, 1997 10:19 PM EDT
The FDA warned today that it had approved neither the "Lei-Home Access HIV Test" nor the "In-Home Hepatitis A Test Kit."
The agency notes the HIV test, for the virus that causes AIDS, is advertised on the Internet as "Personal HIV Test Kit."
Lei-Home Access Care, a division of Jin-Greene Biotechnology, Inc. in Sunnyvale, Calif., distributes both the AIDS and hepatitis kits.
The FDA advises people who have used these kits to call a clinic or health professional for a reliable test.
The agency emphasizes these tests should not to be confused with an HIV test kit that has won FDA approval. The FDA has cleared only the Home Access HIV-1 Test System, or Home Access Express HIV-1 Test System.
This approved kit allows someone to collect a finger-prick blood sample and mail it to a laboratory for confidential testing. Users phone in for results and can speak with trained counsellors. The Home Access Health Corporation of Hoffman Estates, Ill., makes the approved test.
The FDA has not cleared any home-use test kits for hepatitis A.
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