Testing devices for COVID-19: Antigen testing devices
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Antigen-based tests detect specific proteins on the surface of the virus. They’re often called rapid tests, as they typically provide results in less than an hour. In general, antigen tests are used by a health care professional or trained operator at point-of-care, but lab-based antigen tests exist as well. Some technologies require the use of a portable digital reader, while others use an optical readout and format similar to a disposable pregnancy test.
We are prioritizing the review of point-of-care antigen-based tests intended to diagnose COVID-19 and have authorized several tests. See the list of authorized testing devices.
Potential uses of rapid antigen-based tests
The Public Health Agency of Canada’s National Microbiology Lab (NML) developed an interim guidance on antigen testing. This document highlights the importance of identifying scenarios where the use of antigen tests may further strengthen the public health response, by expanding access to testing outside of laboratories.
The guidance provides:
- information on the use of rapid antigen detection tests (RADT) for point of care
- according to the NML, these tests should be used in a program that sees people get repeat tests
- a proposed framework for implementing these tests
The proposed framework includes a number of suggestions. For example, the framework suggests considering:
- positive results from RADTs as a "presumptive positive" case until a reference nucleic acid-based (PCR) method confirms the positive result
- the clinical context of the test (asymptomatic as opposed to symptomatic) and the pre-test probability of infection in the person tested when interpreting a negative RADT result
- further testing using a nucleic acid-based (PCR) reference method for patients with negative RADT results where the pre-test probability of COVID-19 remains high (for example, a known contact, high community transmission), to direct further management
- if the pre-test probability is low, then the person can be monitored and remain out of isolation
As the guidance indicates, these new tests are still being investigated, and their performance characteristics are not yet fully understood. Viral loads, which are generally high in early disease, are sufficiently above the limit of detection for some antigen tests for the first 5 days of symptoms. After this initial period, performance decreases rapidly as the viral load starts to decrease.
Potentially beneficial characteristics include:
- faster turnaround time
- a lower per-test cost
- the ability for non-professionals to do the test
These characteristics suggest that antigen tests will have an important role to play in the next phase of the response.
How to get authorization
The interim order to import and sell medical devices related to COVID-19 allows Health Canada to carry out expedited evaluations of applicable applications. This is the most effective pathway for manufacturers wanting to apply for authorization for COVID-19 test devices. As part of the application, manufacturers will be required to explain the safety, effectiveness and quality of their medical device. We are waiving the fees for these applications.
Health Canada refers to guidance published by the US Food and Drug Administration (FDA) on antigen detecting tests.
For antigen-based testing devices intended for laboratory or point-of-care use:
We have also set minimum standards for sensitivity for a COVID-19 antigen test to meet in order for us to consider it for authorization. This notice complements the published FDA guidance.
For antigen tests intended for self-testing:
Manufacturers following the FDA guidance for molecular and antigen tests for non-laboratory use should note that Health Canada expects them to follow the guidance for non-prescription testing. This is because the distinction made by the FDA between prescription and non-prescription testing does not exist in Canada.
The FDA guidances are in a template format and outline the requirements that these products must meet.
Health Canada has additional labelling specifications relating to vaccinations and emerging variants of public health concern that are not included in the FDA guidances.
Due to the approval and distribution of vaccines in Canada, manufacturers must add a statement that includes the following limitation or one that conveys the same meaning to their labels:
“The performance of this device has not been assessed in a population vaccinated against COVID-19.”
Manufacturers that submit evidence of their device’s performance in a vaccinated population may have this requirement waived.
In response to the emergence of a number of SARS-CoV-2 variants of public health concern, Health Canada requires the following before authorizing an application.
- Manufacturers must assess the impact of new variants of public health concern on their test, taking into consideration performance and labelling, and include this assessment in their application. If it’s included in the submitted in-silico and/or wet testing, this must be stated clearly.
- Manufacturers must indicate how they plan to mitigate any new risks, including timelines for addressing these risks.
- Manufacturers must provide a proactive risk management plan to assess, address and notify Health Canada of their findings related to any novel published variants of public health concern.
- Labels must include a statement that includes the following limitation or one that conveys the same meaning:
“The performance of the device has not been assessed on specimens from individuals who have been infected with emerging variants of SARS-CoV-2 of public health concern.”
Manufacturers that submit evidence of their device’s performance in specimens from individuals infected with emerging variants may be able to have this requirement adjusted.
To submit an application for authorization, follow these 4 steps:
- Review the guidance document on how to apply for medical devices for use in relation to COVID-19, under the interim order.
- Review the submission requirements for antigen-based devices provided on this page.
- Prepare your submission package. Each submission must include enough information, including relevant test data and device labelling, so that Health Canada can authorize the device.
- Submit your application to the Medical Devices Directorate at firstname.lastname@example.org.
For information about the licensing or authorization of medical devices in Canada, please contact the Medical Devices Directorate at email@example.com.
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