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Date: Friday, September 26, 1997
FOR IMMEDIATE RELEASE
Contact: FOOD AND DRUG ADMINISTRATION, Media Press:(301) 827­6242, 
Broadcast Media: (301) 827­3434,Consumer Hotline: (800) 532­4440

FDA Warns Consumers About Two Unapproved Home­Use Test Kits
FDA is advising consumers and pharmacists about two unapproved, fraudulently marketed home­use test kits distributed by Lei­Home Access Care, a division of Jin­Greene Biotechnology, Inc. in Sunnyvale, Calif. One test kit is advertised on the internet as the "Personal HIV Test Kit" and is labeled the "Lei­Home Access HIV Test." The other test kit is labeled as an "In­home Hepatitis A Test Kit." Results from any unapproved tests for home use are unreliable.

The human immunodeficiency virus(HIV) is the virus that causes the disease AIDS. The hepatitis A virus, usually a food­borne illness, causes a mild, rarely serious, liver disease. FDA is recommending that pharmacists remove any of these unapproved test kits from their stores.

Currently, the only approved HIV home collection system being marketed in the United States is the Home Access HIV­1 Test System (also called the Home Access Express HIV­1 Test System), manufactured by the Home Access Health Corporation, Hoffman Estates, Ill. With this home system, the user mails a dried blood sample obtained from a finger prick to a laboratory for analysis. Confidential, highly accurate test results are obtained by telephone, with a trained counselor available. FDA has not approved a hepatitis A home test kit.

FDA is advising consumers who purchased the "Lei­Home Access HIV Test" or the "In­Home Hepatitis A Test Kit" to consult with a health professional about other available approved tests that detect antibodies to the HIV virus and the hepatitis A virus.

Note: HHS press releases are available on the World Wide Web at: www.hhs.gov.