Health Canada is advising Canadians not to use Clean Testing HIV Home Test Kit, or any HIV home test kits, as these are unlicensed medical devices and may provide false test results. The Clean Testing HIV Home Test Kit is promoted as a self-test kit to determine whether an individual has been infected with Human Immunodeficiency Virus (HIV). This kit is unlicensed and has not been evaluated by Health Canada for safety and effectiveness.
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 requested that Clean Testing stop sale of the device and notify all customers not to use the kit. Health Canada will continue to monitor the situation and take appropriate action to mitigate the risk. Health Canada advises Canadians not to purchase these products from the Internet or from any other source.
Patients who are concerned about their HIV status should talk to their doctor. Patients that have used these test kits should also consult with their doctor to evaluate the need to conduct proper testing. Health Canada reminds Canadians that home test kits are not a replacement for professional health care, and that patients who have used a home HIV test kit should contact their physician for follow-up testing and counselling.