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 Statesthe 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.