Federal Trade Commission
Jun 24, 1999
Tests for HIV Can Be Inaccurate, FTC Warns
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
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.