Health Canada: Types of testing devices for COVID-19

eAwaz Medicine

Ottawa – Most submissions to Health Canada are for 3 types of commercial testing devices:
• nucleic acid-based testing
• antigen-based testing
• serology-based testing
There are different ways that samples can be collected to test for COVID-19. They can be collected by a health care professional or, in some instances, by the patient (self-collection), through a:
• nose swab
• throat swab
• saliva sample
For more information on the requirements for classifying and authorizing nose and throat swabs, please consult the guidance on test swab safety and effectiveness. Saliva collection devices are generally classified as Class I devices. For more information on the requirements for classifying and authorizing these devices, please consult medical devices related to COVID-19.
Each testing device must indicate in the instructions for use the type(s) of sample collection that can be used with the device. Manufacturers must provide evidence in their submission to demonstrate the device can provide accurate results with the specified sample collection method(s).
Similarly, the instructions for use must indicate the intended user (for example, lab staff, health care professional, general public), which also determines the intended settings (for example, lab, doctor’s office, pharmacy, bedside, home).