COVID-19 serological testing devices: Notice on sensitivity and specificity values

Published: June 24, 2020

Purpose and background

The purpose of this notice is to communicate target and minimum values of sensitivity and specificity for COVID-19 serological testing devices.

Health Canada has published guidance on requirements for serological antibody tests submitted under the COVID-19 Interim Order (IO). This guidance outlines the requirements that these products must meet.  Refer to the authorization of serological testing devices and a list of authorized testing devices for more information. 

This document addresses only sensitivity and specificity for serological tests. It complements the published guidance.

Sensitivity and specificity are measures of the diagnostic accuracy of a testFootnote 1 :

They are both important measures to determine whether test information is useful and reliable.

Minimum values for sensitivity and specificity

Health Canada does not usually set minimum standards for sensitivity and specificity.  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. We have received an unprecedented number of applications for serological tests to detect antibodies to SARS-CoV-2.  For this reason, we are taking a different approach.

We have set minimum standards for sensitivity and specificity that a COVID-19 serological test must meet in order for us to consider it for authorization.  Tests with sensitivity and specificity values below these minimums do not meet the criteria of 5(c) and (d) of the Interim order respecting the importation and sale of medical devices for use in relation to COVID-19, and will not be authorized.

Health Canada considers the following to be unacceptable for authorization:

Sensitivity and specificity values below these values will produce too many false positive or false negative results. These tests will not be authorized, regardless of any other factors. 

Additional factors

Tests with sensitivity and specificity values above the minimums will not necessarily be authorized.  We consider many factors when making a decision to authorize a testing device.  These include:

Testing devices meeting these criteria are better able to demonstrate that they meet the requirements of paragraphs 5(c) and (d) of the Interim Order.

While these factors do not directly lead to authorization or refusal, we use them as guides when considering a test’s performance.  The sensitivity and specificity of tests when used in the field may be slightly lower than the values identified through pre-market studies. This is because pre-market studies tend to be conducted under optimal conditions.  These additional factors make it more likely that the test will still perform well in a clinical setting.

Future considerations

Health Canada’s target values align well with international targets from other trusted regulators, as set out in the table below. However, as more research results become available, we may revise these values accordingly.

Health Canada welcomes applications for technologies that exceed the minimum limit values. We will consider their performance in relation to the target values when making a decision whether to authorize the device.  We will also continue to monitor emerging science and international experience to determine whether we need to amend these values.

International Comparison of Target Values for Sensitivity and Specificity

Country Sensitivity Specificity
UK MHRA >98% (95% CI 96%-100%) on specimens collected 20 days or more after the first appearance of symptoms >98% (95% CI 96%-100%)
US FDA 90% overall
70% IgM
90% IgG
95% (overall - total)
Health Canada 95% for IgG or total antibodies in samples collected 2 weeks or more after symptom onset. 98%

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