TORONTO - Health Canada is advising consumers not to use the Clean Testing HIV Home Test Kit, or any HIV home test kits, as they are unlicensed medical devices and may provide false results.
The Clean Testing HIV Home Test Kit, available online at cleantesting.com, is advertised as a self-test kit to determine whether an individual has been infected with the human immunodeficiency virus (HIV).
"This kit is unlicensed and has not been evaluated by Health Canada for safety and effectiveness," the federal department said Monday in an advisory. "Inaccurate test results may fail to indicate HIV in an infected individual or indicate HIV when none is present."
Under the Medical Devices Regulations, home HIV test kits require a device licence issued by Health Canada before they can be advertised or sold. It is illegal to advertise or sell unlicensed medical devices of this class in Canada.
Currently, there are no HIV test kits that 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. The department will continue to monitor the situation and take appropriate action. Canadians should not purchase these products via the Internet or from any other source.
Anyone concerned about his or her HIV status should talk to their doctor. Those who have used these test kits should also consult their physician to evaluate the need to conduct proper testing. As well, Health Canada says anyone who has used a home HIV test kit should contact their doctor for follow-up testing and counselling.
Complaints involving home HIV test kits can be reported to the Health Products and Food Branch Inspectorate by calling, toll-free, 1-800-267-9675.
