FDA Talk Paper
February 7, 2005
Media Inquiries: 301-827-6242
Consumer Inquiries: 888-INFO-FDA
This talk paper was originally issued Feb. 7, 2005, and was revised Feb. 11, 2005, to clarify that, whereas no home-use diagnostic kits marketed by Globus Media are approved by FDA, one HIV home collection test system made by a different manufacturer has FDA approval.
FDA Warns Consumers Not to Use Home-Use Diagnostic Kits Marketed by Globus Media
The Food and Drug Administration (FDA) is warning consumers not to use unapproved home-use diagnostic test kits that have been marketed nationwide via the Internet by Globus Media, Montreal, Canada. The use of these products could result in false results that could lead to significant adverse health consequences. The illegal kits are labeled as:
Rapid HIV Test Kit
Rapid Syphilis Test Kit
One Step Cassette Style Cocaine Test
One Step Cassette Style Marijuana (THC) Test
One Step Cassette Style Amphetamine Test
Rapid Dengue Fever Test
One Step Midstream Style HCG Urine (Home)
FDA learned of the problem from two consumer complaints.
FDA has not approved or evaluated the performance of any of Globus Media's products. As a result, consumers cannot know with any degree of certainty that test results are correct. For example, a person testing positive for HIV (human immunodeficiency virus, or the AIDS virus) using one of these tests may not be infected with HIV, or, worse, someone infected with HIV may test negative and not seek medical treatment or spread the virus to others.
The tests were sold through websites and distributed throughout the U.S., usually by overnight delivery services. These have been made available for sale on several websites, including www.htkit.com and www.hstkits.com. The kits usually are contained in a paper envelope with instructions inside the packaging. The envelope, instructions and packaging may not accurately identify the manufacturer, packer or distributor. The name of the kit appears on the instructions.
Consumers who have these products should not use them. Anyone who has used one of these test kits should be retested using valid test methods. Only one HIV home collection test system is approved by FDA and legally sold in the United States. This test, sold as either "The Home Access HIV-1 Test System" or "The Home Access Express HIV-1 Test System" is manufactured by Home Access Health Corporation and allows blood samples to be taken at home which people then send to a laboratory for testing. No home-use test kits intended for diagnosing syphilis and dengue fever are approved for sale in the U.S.
The FDA has issued an import alert which alerts FDA field personnel to the possible importation of the Globus Media devices, provides guidance as to their detention and refusal of admission into the U.S., and also advises U.S. Customs officials about these products.