Warn patients about bogus at-home tests
Alert your patients about the dangers of certain at-home diagnostic tests. The Food and Drug Administration (FDA) has issued an alert concerning use of unapproved home-use diagnostic test kits marketed over the Internet.
The kits, marketed by Globus Media of Montreal, 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, and One Step Midstream Style HCG Urine (Home) Pregnancy Test.
The tests were sold through web sites and distributed throughout the United States, usually by overnight delivery services, according to the FDA. The kits usually are packaged in a paper envelope, with instructions inside the packaging. The envelope, instructions, and packaging may not accurately identify the manufacturer, packer, or distributor; however, the name of the kit appears on the instructions, states the FDA.
No home-use test kits intended for diagnosing HIV, syphilis, and dengue fever are approved for sale in the United States, according to the FDA. It advises that use of such products could result in false results that could lead to significant adverse health consequences.
The Food and Drug Administration (FDA) has issued an alert concerning use of unapproved home-use diagnostic test kits marketed over the Internet.
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