Home HIV test kits not approved, Health Canada warns

Canadians should not use the Clean Testing HIV Home Test Kit, or any other HIV home test kits, because they are unlicensed medical devices and may give false results, Health Canada advises.

The Clean Testing HIV test is sold online and is advertised as a self-test kit to determine HIV infection.

"This kit is unlicensed and has not been evaluated by Health Canada for safety and effectiveness," the department said in an advisory Monday.

"Inaccurate test results may fail to indicate HIV in an infected individual, or indicate HIV when none is present."

Under medical devices regulations, home HIV test kits require a device licence from Health Canada before they can be advertised or sold.

Currently, no home HIV test kits have been authorized for sale for home use in Canada.

Health Canada has asked Clean Testing to stop selling the device and to notify all customers not to use the kit.

On Tuesday, the company's website said "No Canadian orders accepted."

Those who have used the home test kits should also consult their doctor for followup testing and counselling, Health Canada said.

People who are concerned about their HIV status should talk to their doctor. 

Complaints involving home HIV test kits can be reported to the Health Products and Food Branch Inspectorate by calling the toll-free hotline at 1-800-267-9675.