Health Canada Releases Guidance on COVID-19 Antigen Testing

October 15, 2020

Health Canada has published new guidance describing the minimum values it will accept for sensitivity for COVID-19 antigen testing devices.

Sensitivity is a measure of the accuracy of a test against a reference standard, but there is currently no standard, so the accuracy of positive results from a COVID-19 antigen test is expressed as the proportion of subjects with the target condition in whom the test is positive, the agency said.

Sensitivity below 80 percent will not be considered acceptable for authorization because the tests could produce too many false negative results. Health Canada said this value aligns with the FDA’s target.

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