FTC Warns Against Home-Use Tests for HIV

The Federal Trade Commission(FTC) released a consumer alert regarding home-use test kits for the human immunodeficiency virus (HIV). According to the FTC, some of the kits being marketed and sold on the Internet are giving users false information about their HIV status.

The FTC recently tested HIV kits advertised and sold on the Internet for self-diagnosis at home. Kits tested by the FTC have registered negative when used on a known HIV-positive sample. Using one of these kits could mislead persons who might be infected with HIV into thinking that they are free of the virus.

Although Internet ads for these home-use kits may say they are for sale outside the United States only, consumers in the United States have been able to purchase the kits. Some advertisements state or imply that the kits have been approved by the World Health Organization (WHO) or a similarly well-known health organization, or that the home-use test kits have been approved by the FDA. The World Health Organization does not approve or license HIV test kits, and the FDA has not approved any home-use HIV test kit for sale in the US.

FDA-Approved Home Collection Test System

The FDA has approved one HIV home collection test system for sale in the United States—the Home Access Express HIV-1 Test System. Manufactured by Home Access Health Corporation, this home system allows consumers to collect a blood sample in the privacy of their home, then requires that the sample be sent to a laboratory for analysis.

Safe, reliable HIV testing can be done only through a medical professional, a clinic, or through use of the Home Access Express HIV-1 Test System, said the FTC.