Updated policy position COVID-19 rapid antigen self-testing devices used for serial testing: Notice to industry

Date: October 14, 2022

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On this page

• Background and purpose
• New policy position

Background and purpose

On July 9, 2021, Health Canada published a policy position on COVID-19 rapid antigen testing devices that use serial testing for people without symptoms. The policy allowed us to authorize these tests for serial testing use on the condition that manufacturers provide additional studies to support the serial testing claim.

This policy was based on:

• reports on the possible similarity of viral loads between people with and without symptoms
• technical reports and key messages on the use of rapid antigen tests
• strategies implemented by our international regulatory partners
• recommendations by the U.S. Food and Drug Administration (FDA) to allow for more flexibility during pre-market evaluation of COVID-19 testing devices during the pandemic

Recently, the FDA collaborated with the National Institutes for Health (NIH) to design a comprehensive study to assess the performance of COVID-19 antigen self-tests. The results of this study showed that serial testing, 48 hours apart, detected:

• more than 90% of SARS-CoV-2 infections in people with symptoms (testing 2 times)
• 79% of SARS-CoV-2 infections in people without symptoms (testing 3 times)

On August 11, 2022, the FDA updated its safety communication on at-home COVID-19 antigen tests. The communication states that the FDA is making the study results available for all at-home COVID-19 antigen test manufacturers as a resource to support serial testing claims.

New policy position

Based on the evolving science, Health Canada agrees with this updated serial testing strategy.

To help ensure the most accurate test result can be obtained, we recommend that manufacturers of COVID-19 antigen self-tests add a serial testing claim to instruct people who are suspected of being infected with SARS-CoV-2 virus:

• After the first negative test, test again 48 hours later, if you have symptoms.
• After the first negative test, test again 48 hours later and then another 48 hours after the second negative test if you do not have symptoms.

Clinical studies to establish COVID-19 test performance, in accordance with the applicable FDA template(s), are still required before a COVID-19 testing device can be authorized. Additional studies to support serial testing performance in people with and without symptoms will generally not be required. The exception is if the manufacturer wishes to conduct a study of similar quality to the FDA/NIH study, to support alternate serial testing claims.

Health Canada expects similar serial testing performance with point-of-care (POC) COVID-19 antigen tests. Following a negative test result from a POC COVID-19 antigen test, we recommend that repeat, or serial, testing protocols be followed. A self-test may be used for this additional testing.

We will continue to work with manufacturers to provide guidance on how they will be able to use these study results to support serial testing claims for their tests. This includes manufacturers of authorized rapid antigen tests and those who have applications under review.