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.  In fact, no home-use
test kits intended for diagnosing HIV*, syphilis and dengue fever are
approved for sale in the U.S.  The use of these products could result in
false results (though there is no confirmed evidence of false positives)
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)
        Pregnancy Test
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.  They have been made available for
sale on several websites, including www.htkit.com <www.htkit.com>
<http://www.htkit.com <http://www.htkit.com> > and www.hstkits.com
<www.hstkits.com>  <http://www.hstkits.com <http://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.
The FDA has issued an import alert which alerts FDA field personnel to the
possible importation of these 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.
Other unapproved tests may also be available through the Internet.  You can
find a list of FDA approved / licensed tests for HIV and Hepatitis on the
FDA website at http://www.fda.gov/cber/products/testkits.htm
<http://www.fda.gov/cber/products/testkits.htm> .
*Please not that one licensed/approved diagnostic home collection kit for
HIV, which is mailed to a laboratory for testing and confirmation, is
commercially available in the United States.
Richard Klein
HIV/AIDS Program Director
Office of Special Health Issues
Food and Drug Administration