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The purpose of this notice is to communicate minimum values of sensitivity for COVID-19 antigen testing devices.

Nucleic acid-based testing is also called molecular testing, and is often called PCR. Molecular tests detect the virus genetic material (nucleic acids). Public health laboratories in Canada and around the world use nucleic acid-based testing to diagnose COVID-19 infection. This test is the gold standard to diagnose active COVID-19 infection in patients with symptoms.

Serological tests do not detect the virus itself. Instead, they detect the antibodies produced in response to an infection. Serology tests are also known as antibody tests. Serological tests are not appropriate for diagnosing COVID-19.

As the pandemic evolves, we are continuously updating our guidance and positions in light of the new scientific information available to us. We are open to reviewing all testing solutions as they become available.

This guidance document presents the criteria for safety and effectiveness that apply to test swabs used for COVID-19 sampling. It also provides guidance on how to meet these criteria in an application under the IO pathway.

This guidance document presents the criteria for safety and effectiveness that apply to test swabs used for COVID-19 sampling. It also provides guidance on how to meet these criteria in an application under the IO pathway.

COVID-19 is a new disease. A vaccine or therapy to treat or prevent this disease has not yet been developed. However, the COVID-19 pandemic has resulted in a global review of therapies that may be used to treat or prevent the disease. Canada is speeding up the importation and sale of medical devices used to diagnose, treat or prevent COVID-19.

A near patient in vitro diagnostic device (IVDD) is used for: point-of-care testing in a health care setting (for example, doctor’s office, pharmacy, at the bedside) or self-testing ( for example, used by individuals at home). Typically, these rapid test devices are simple to use and provide visual or simple results within a short time.

To assist with Canada’s response to COVID-19, the Honourable Patty Hajdu, Minister of Health, announced that she has signed an Interim Order to allow expedited access to COVID-19-related medical devices for use by healthcare providers, including diagnostic test kits.

The first version of the National laboratory testing indication guidance for COVID-19 document was developed at the beginning of the COVID-19 outbreak. The original guidance document was finalized and approved by the Special Advisory Committee on April 16, 2020. Since then, significant developments in four areas have prompted the need to review and update the guidance. This document was updated in May 2020 to reflect these developments.