AEGiS-FDA: FDA Warns Consumers About Two Unapproved Home-Use Test Kits

Important note: Information in this article was accurate in 1997. The state of the art may have changed since the publication date.

FDA Warns Consumers About Two Unapproved Home-Use Test Kits

Food and Drug Administration, U.S. Department of Health and Human Services - September 26, 1997

FDA is advising consumers and pharmacists about two unapproved, fraudulently marketed home-use test kits distributed by Lei-Home Access Care, a division of Jin-Greene Biotechnology, Inc. in Sunnyvale, Calif. One test kit is advertised on the internet as the "Personal HIV Test Kit" and is labeled the "Lei-Home Access HIV Test." The other test kit is labeled as an "In-home 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 food-borne 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 HIV-1 Test System (also called the Home Access Express HIV-1 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 "Lei-Home Access HIV Test" or the "In-Home 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.

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SOURCE: Food and Drug Administration (FDA).

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Always watch for outdated information. This article first appeared in 1997. This material is designed to support, not replace, the relationship that exists between you and your doctor.

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