FDA Warning - Unapproved Home-use Diagnostic Test Kits
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 <http://www.htkit.com> and 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.
*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.
HIV/AIDS Program Director
Office of Special Health Issues
Food and Drug Administration