COVID-19 antigen testing devices: Notice on minimum value for sensitivity
On February 22, 2023, Health Canada introduced the Regulations Amending the Medical Devices Regulations (Interim Order No. 3 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19). These Regulations accelerate access to COVID-19 medical devices that have an urgent public health need in Canada. They also make it possible to continue to import and sell COVID-19 medical devices authorized under the interim order. Health Canada will be updating the content of this page soon. For more information, please refer to the notice on Amendments to Medical Devices Regulations to continue importation and sale of COVID-19 medical devices and guidance on Medical devices for use in relation to COVID-19.
Stakeholders should read references to the numbered provisions of Interim Order No. 3 that appear in this page as references to the equivalent provisions in Part 1.1 of the Medical Devices Regulations.
Date published: September 29, 2020
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Purpose and background
The purpose of this notice is to communicate minimum values of sensitivity for COVID-19 antigen testing devices.
Health Canada refers to guidance published by the U.S. Food and Drug Administration (FDA) on antigen detecting tests. This guidance outlines the requirements that these products must meet.
This document addresses only sensitivity for antigen tests. It complements the published FDA guidance.
Sensitivity is technically a measure of the accuracy of a test against a reference standard. No such standard exists at this time. Therefore, the accuracy of the positive results from a test is currently expressed as the positive percent agreement (PPA). The term "sensitivity" is used throughout this document in place of "PPA" for ease of reading.
- sensitivity is the proportion of subjects with the target condition in whom the test is positive
It is an important measure to determine whether test information is useful and reliable.
Minimum value for sensitivity
Health Canada doesn’t 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 third 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 below 80%
Sensitivity values below this level will produce too many false negative results. These tests will not be authorized, regardless of other factors.
Health Canada’s target value aligns with the FDA target. However, as more research results become available, we may revise this value accordingly.
Health Canada welcomes applications for technologies that meet or exceed the minimum limit value. We will continue to monitor emerging science and international experience to determine whether we need to amend this value.
Please email your questions or comments about this notice to: email@example.com.
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