RE:Sensitivity of sona is only... Minimum value for sensitivity
Health Canada does not usually set minimum standards for sensitivity. Normally we review the submitted data to determine whether a test performs to the standard claimed by the manufacturer. We then compare that to the standard claimed by similar tests.
However, the COVID-19 pandemic is a unique public health crisis. For this reason, we are taking a different approach.
We have set minimum standards for sensitivity that a COVID-19 antigen test must meet in order for us to consider it for authorization. Tests with sensitivity below this minimum do not meet the criteria of 5(c) and (d) of the interim order on the importation and sale of medical devices for use in relation to COVID-19. For this reason, they will not be authorized.
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.
https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/medical-devices/testing/antigen.html#a2