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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
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.