June 24, 2009
Health Canada on Monday issued an advisory warning consumers not to use any HIV home test kits, as the products are not licensed medical devices and can provide false results. In particular, Health Canada cited the "Clean Testing HIV Home Test Kit" being sold online.
"This kit is unlicensed and has not been evaluated by Health Canada for safety and effectiveness," the advisory states. "Inaccurate test results may fail to indicate HIV in an infected individual or indicate HIV when none is present."
No home testing kit for HIV is currently authorized for sale in Canada. It is illegal to advertise or sell unlicensed medical devices in Canada.
Health Canada has asked Clean Testing to stop selling the product and to notify customers to not use the test. The agency is continuing to evaluate the situation and said it will respond appropriately.
In the meantime, Canadian consumers should not purchase Clean Testing or similar at-home HIV test kits from the Internet or other sources, Health Canada said. Those who have used a home HIV test kit should consult their physician about the need for follow-up HIV testing and counseling.
To lodge a complaint involving home HIV testing kits, telephone the Health Products and Food Branch Inspectorate toll-free at 1-800-267-9675.