The Federal Trade Commission warns that home testing kits for Human Immunodeficiency Virus may not give accurate results. HIV is the virus that causes AIDS.
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 at http://www.fda.gov.