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Home-Use Tests for HIV Can Be Inaccurate, FTC Warns

If you’ve tested yourself at home for HIV — Human Immunodeficiency Virus, the virus that causes AIDS — you may want to do it again. According to the Federal Trade Commission, some home-use test kits can give users false information about their HIV status.

The FTC recently tested HIV kits advertised and sold on the Internet for self diagnosis at home. In every case, the kits showed a negative result when used on a known HIV-positive sample — that is, when they should have shown a positive result. Using one of these kits could give a person who might be infected with HIV the false impression that he or she is not infected.

Although Internet ads for these home-use kits may say they are for sale outside the U.S. only, consumers in the U.S. have been able to purchase these kits. Some ads 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 U.S. Food and Drug Administration (FDA).

WHO does not approve or license HIV test kits. The FDA has not approved any home-use HIV test kit for sale in the U.S. However, the FDA has approved one HIV home collection test system for sale in the U.S. — the Home Access Express HIV-1 Test System. Manufactured by Home Access Health Corporation, this home system allows consumers to collect the 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 or a clinic, or through use of the Home Access Express HIV-1 Test System, says the FTC.

For more information about HIV home-use test kits, please visit the FDA website.

The FTC works for the consumer to prevent fraudulent, deceptive and unfair business practices in the marketplace and to provide information to help consumers spot, stop and avoid them. To file a complaint or to get free information on consumer issues, visit or call toll-free, 1-877-FTC-HELP (1-877-382-4357); TTY: 1-866-653-4261. The FTC enters Internet, telemarketing, identity theft and other fraud-related complaints into Consumer Sentinel, a secure, online database available to hundreds of civil and criminal law enforcement agencies in the U.S. and abroad.

June 1999