Health Canada Requires Higher Sensitivity for COVID-19 Tests
Health Canada is fast-tracking the review of submissions related to rapid antigen detection tests (RADTs) and nucleic acid tests and has set tougher standards.
The agency noted that it does not usually set minimum standards for test sensitivity. However, during the pandemic it is taking a different approach and considers a sensitivity below 80 percent unacceptable.
“Sensitivity values below this level will produce too many false negative results. These tests will not be authorized, regardless of other factors,” the agency said.