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FDA issues warning on Quebec medical tests
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Canadian Press
Date: Tuesday Feb. 8, 2005 7:57 AM ET
QUEBEC A Canadian company's promise of easy home tests for HIV and syphilis cannot be trusted, the United States Food and Drug Administration warned Monday.
The FDA issued an alert to U.S. consumers, saying a series of home medical test kits sold over the Internet by Montreal-based Globus Media are illegal, untested and could give misleading results.
"The use of these products could result in false results that could lead to significant adverse health consequences," said the FDA statement.
"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."
The FDA issued the warning after complaints from two consumers in the United States.
Health Canada followed by announcing its own investigation on Monday.
The kits sold on several websites promise quick tests to tell customers if they have illnesses like Dengue fever, syphilis or HIV, the virus that causes AIDS.
The company also sells other kits purporting to check for the use of drugs including amphetamine, marijuana and cocaine. Another company site sells pregnancy tests.
The tests sell for $11.70 to $39.14 and are available for shipping to more than 100 countries, including Canada.
Globus officials did not respond to several telephone and e-mail interview requests on Monday. A Globus corporate website says, "Globus Media E-Marketing Solutions is a Montreal company specializing in web design and e-commerce solutions."
Health Canada will investigate whether Globus Media is selling unapproved test kits in Canada. Officials are particularly concerned about the HIV test.
"We're checking on all of those devices, but our biggest concern is with HIV because of the seriousness of the disease," said spokeswoman Nathalie Lalonde.
A statement issued by Health Canada said the test kits are not approved for sale in Canada. The agency has received no complaints and has no evidence so far that any kits are being sold in Canada.
Health Canada must issue a medical device license before HIV test kits can be imported or sold in Canada, Lalonde said.
The FDA says Globus websites pitch the test kits by bragging that customers can get results within minutes with a urine swab or blood obtained through a fingertip pin prick.
The sites where the kits are sold do not mention Globus, but FDA spokeswoman Cathy McDermott said the FDA has established Globus is the company behind them.
One site where kits are sold say they are "produced by an innovative Canadian biotechnology company that is committed to the development, commercialization and world-wide marketing of cost-effective diagnostic test kits for the initial screening of HIV."
According to the FDA, the kits are shipped by overnight courier to customers. Packaging and instructions do not always identify the kit manufacturer, the FDA says.
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I applaud the budget, even though Health Care and education may stay unscathed. Sadly this cannot last and I worry to later this year where cuts will become enviable. If anything, this provides the Wildrose Alliance plenty of ammo when an election is called.

