On November 2, 2020, Health Canada granted a medical device license to a one-minute, finger-prick HIV blood test. Known more commonly as the HIV self-test, this device is manufactured by bioLytical Laboratories based in BC. 

The approval follows research and development associated with the Solutions Network: REACHing the Undiagnosed Testing for linkages to care for HIV and Hepatitis C project. The study was submitted by principal investigator Sean Rourke to regulators for approval earlier this year. The project is a collaboration of:

  • CATIE
  • CAFAR
  • CAHR
  • CBRC
  • CSIH
  • National Collaborating Centre for Infectious Diseases 
  • REACH 3.0

In our last newsletter, the OAN shared slides presented during a webinar presentation detailing the outcome of a recent survey of roughly 300 front-line providers to: “examine the knowledge, acceptability, readiness, usability, and supports available for accessing HIV self-testing in Canada.”

You can review the slides in French or English

Read more about the approval.