- WASHINGTON - The U.S. government warned consumers Friday to beware of HIV
home tests sold over the Internet that promise quick results but can give
false readings on whether patients have the virus that causes AIDS.
- The Federal Trade Commission, on its
Web site, said consumers should not trust tests saying patients can diagnose
themselves at home in 15 minutes or less.
- More than a dozen HIV home test kits
are being advertised on the Internet, the Food and Drug Administration
said on its Web site. But the only test the agency has approved requires
patients to mail blood samples collected at home to a medical laboratory
- The FDA said its Office of Criminal Investigations
was investigating companies and individuals involved in the sale, distribution
or manufacture of unapproved HIV home test kits.
- The FTC said it tested several of the
self-diagnosis kits advertised on the Internet, some of which claimed false
endorsements from the FDA or the World Health Organisation.
- "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,'' the FTC said.
- The only test with FDA approval is the
Home Access Express HIV-1 Test System, made by Home Access Health Corporation.
Patients prick their fingers to draw blood that is collected on special
paper and sent to a lab for analysis. Clinicians offer counselling when
patients, who keep their identities anonymous, call for results.
- The unapproved tests let patients use
either blood or saliva, mix it with a developing solution and watch for
an indicator, such as a red dot, the FDA said.
- "Although unapproved tests might
be promoted as sensitive and reliable, the consumer has no guarantee that
the results produced by the test are, in fact, accurate,'' the FDA said.
- One HIV home test has already led to
criminal prosecution. The FDA said Lei-Home Access Care of Sunnyvale, Calif.,
advertised its product on the Internet as the "Personal HIV Test Kit''
and also offered it through pharmacies.
- The FDA warned consumers about the test,
which it called "medically useless,'' in 1997 and said the distributor
was recently sentenced to five years in prison.