MARCH 15, 2005
VOLUME 2 NO. 5
 

FDA slams Montreal company over do-it-yourself HIV tests


Do-it-yourself is all the rage these days. Turn on the TV and you'll be hard pressed to avoid being bombarded by Changing Rooms-style programs. But according to the FDA, one Quebec company has taken this plucky DIY ethic a step too far, by selling at home diagnostic tests for AIDS over the net — and they can't be trusted. The US regulatory body issued a warning after two American consumers complained about the accuracy of the tests.

The tests

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 test
Pregnancy test

The tests in question are marketed by Montreal-based Globus Média — a company that specializes not in medical supplies, but in e-marketing and web design.

A statement on the FDA website says the use of these "illegal kits" could "result in false results that could lead to significant adverse health consequences."

BUYER BEWARE
Here at home, Health Canada says it's reviewing the case. "The test kits mentioned on the FDA site for HIV are not approved for sale in Canada," says spokesperson Nathalie Lalonde. She adds that there's no evidence the tests are even being sold in Canada.

In terms of the other home test kits being marketed by Globus, Ms Lalonde suggests that concerned physicians and consumers check out Health Canada's Medical Devices Active Listing webpage (www.mdall.ca) for a list of approved test kits and proceed with caution. "Our recommendation is to make sure they are getting a device approved by Health Canada."

Globus Média's website has been down since the FDA advisory and no one from the company has been available for comment.

 

 

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