Important note: Information in this article was accurate in 1999. The state of the art may have changed since the publication date.
Important note: Information in this article was accurate in 1999. The state of the art may have changed since the publication date.
Reuters NewMedia - Friday June 18, 1999
Lisa Richwine
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 for analysis.
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 Organization.
"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 counseling 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.
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