HC antigen test guidelines Health Canada considers the following to be unacceptable for authorization:
Sensitivity values below this level will produce too many false negative results. These tests will not be authorized, regardless of other factors.
Future considerations
Health Canada’s target value aligns with the FDA target. However, as more research results become available, we may revise this value accordingly.
Health Canada welcomes applications for technologies that meet or exceed the minimum limit value. We will continue to monitor emerging science and international experience to determine whether we need to amend this value