Warning issued over home tests

WASHINGTON – The government warned consumers Monday not to use certain home diagnostic tests marketed by a Canadian company because they have not been approved for sale in the United States and could give false results.

The Food and Drug Administration said Montreal-based Globus Media Inc. has sold the test kits on several Web sites offering home delivery in the United States. The FDA said it has not evaluated or approved any of them, including tests for pregnancy, HIV and marijuana.

“As a result, consumers cannot know with any degree of certainty that test results are correct,” an FDA statement said.

The agency said it learned the kits were being sold illegally in the United States after receiving complaints from consumers in recent months, including one questioning whether a syphilis test was government-approved and another about false-positives for an HIV test.

Currently, no home tests for HIV, syphilis and dengue fever are approved for U.S. sale.

The products 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); and Pregnancy Test.

The government urged anyone who has used the kits to get retested.

Web sites selling the tests include www.htkit.com and www.hstkits.com. A call to the Montreal company was not immediately returned.

The name of the kit appears on instructions inside the package. However, the FDA said the paper envelope, instructions and packaging may not accurately identify the manufacturer, packer or distributor. The agency said it is still investigating who makes the kits.