Testing devices for COVID-19: Serological testing devices
Health Canada has updated the list of COVID-19 testing devices that no longer have an urgent public health need status. Before submitting an IO application, please consult Medical devices no longer considered to have urgent public health need status: Notice to industry.
On this page
- Serological testing
- Understanding serological testing results
- What Health Canada is doing
- How to get authorization
Serological tests do not detect the virus itself. Instead, they detect the antibodies produced in response to an infection. Serology tests are also known as antibody tests.
Serological tests are not appropriate for diagnosing COVID-19. However, Health Canada is authorizing the sale in Canada of serological testing devices used for the detection of antibodies. Consult the list of authorized testing devices.
For more information on how serological testing is being used in Canada, please consult the Public Health Agency of Canada’s webpage on serology testing.
Understanding serological testing results
Health Canada has published a resource on Information for patients on COVID-19 antibody (serology) testing.
Serological testing detects the presence of antibodies, not the presence of the SARS-CoV-2 virus. This testing is also not to be used to diagnose infection.
The immune response to a virus involves the creation of different types of antibodies produced at different stages of an infection:
- early antibodies, called IgM antibodies, provide the first indication of the body's response to an infection
- these antibodies are not as specific and generally are not as long-lasting, so interpreting their significance requires clinical experience
- IgG antibodies are specific to a virus, such as the SARS-CoV-2 virus
- early research results suggest these antibodies can be reliably detected 14 days after a person is infected with COVID-19
The relationship between antibodies in response to infection and immunity to infection with SARS-CoV-2 is still unknown. It’s unclear whether people with antibodies from previous infection are immune to re-infection or if they are still infectious to others.
The sensitivity of serological testing in elderly or immuno-compromised people is unknown. This is because their age or condition can have an impact on their body's immune response.
Also, antibodies are present for an undetermined period of time after an infection has ended.
For the above reasons, serological test results should be interpreted with caution.
The performance of authorized COVID-19 testing devices has not been assessed in people who are vaccinated against COVID-19. Tests that identify antibodies to the spike protein of the SARS-CoV-2 virus will be unable to distinguish between people who have been infected and those who are vaccinated . Manufacturers of authorized tests will be asked to change their product labelling to reflect the impacts of vaccination on the performance of COVID-19 testing devices.
Health Canada encourages manufacturers to consider the use of recycled/recyclable, reusable, compostable and sustainable materials in the development of test devices. For instance, manufacturers could consider the use of recycled/recyclable packaging materials and inserts and/or reducing one-time use testing components for self-tests.
What Health Canada is doing
We are committed to authorizing reliable technologies for appropriate uses.
Our position concerning serological assays is in line with the World Health Organization. While serological assays play an important role in research and surveillance, they’re not recommended for diagnosis.
We will continue to work with our federal, provincial and international regulatory partners to understand the emerging science on serological testing devices for COVID-19. We continue to collaborate with the National Microbiology Laboratory and our provincial public health laboratory partners. We will also leverage studies on immune responses and serological technologies in Canada and internationally. In April 2020, Canada launched the COVID-19 Immunity Task Force to lead a Canada-wide unified effort to perform serological testing. As part of the task force, Canadian scientists are working to:
- assess if those who have recovered from illness are safe from re-infection
- understand how the immune system reacts to the virus
- understand the rate and consequences of re-infection
The authorized uses for serological technologies will depend on the type of evidence that we receive from manufacturers and from these studies.
Health Canada will continue to keep Canadians informed as new or additional information becomes available.
How to get authorization
As some COVID-19 testing devices are no longer considered to have an urgent public health need, applications for these specific categories of devices will no longer be accepted under Interim Order No. 3. Before submitting an application, manufacturers are encouraged to consult the “Medical devices no longer considered to have urgent public health need status: Notice to industry” page.
The Interim Order No. 3 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.
For serological test requirements, please consult the requirements for serological antibody tests guidance and the notice on sensitivity and specificity values for COVID-19 serological testing devices.
We follow this guidance on serological antibody test requirements, submitted under the COVID-19 interim order, when reviewing serological technologies. Serological tests that show high sensitivity and specificity will be eligible to be authorized. However, we will not authorize products that don’t have enough evidence of effectiveness. Product information must demonstrate the product is safe and effective.
In accordance with the guidance, we will be placing a 'condition' on all authorized serological tests. This action will allow us to monitor performance once the technology is in use in Canada.
Health Canada has additional labelling specifications for vaccinations and emerging variants that are not included in the FDA guidances.
For more information on the current variants of public health concern, please consult the SARS-CoV-2 emerging variants page.
Due to the approval and distribution of vaccines in Canada, manufacturers must include a statement with the same meaning as the following:
“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.
Manufacturers of serological assays that target the spike protein must include 3 statements with the same meaning as the following:
- “The performance of this device has not been assessed in a population vaccinated against COVID-19.”
- “This test identifies antibodies to the spike protein of the SARS-CoV-2 virus and is therefore unable to distinguish between previously infected individuals and vaccinated individuals.”
- The “intended use” of the assay must be modified to include the fact that the test may also detect a response to vaccination.
Manufacturers that submit evidence of their device’s performance in a vaccinated population may be able to have this requirement adjusted.
In light of a number of SARS-CoV-2 variants of public health concern that have emerged, Health Canada requires the following before an application may be authorized:
- Manufacturers must assess the impact of new variants of public health concern on their test, taking into account performance and labelling, and include this assessment in their application. If it’s included in the submitted in-silico and/or wet testing data, 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 with the same meaning as the following:
“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 who submit evidence on how their device performs in specimens from people infected with emerging variants may be able to have this requirement adjusted.
Point-of-care serological pamphlet
Health Canada requires that manufacturers include the information for patients on COVID-19 antibody (serology) testing pamphlet for point-of-care serological tests. This resource explains the limitations of test results to patients.
However, for the purposes of distribution, manufacturers may include either a physical copy or the internet address for this pamphlet in their labelling materials. Make sure that all potential users are able to access the information.
Manufacturers will have to indicate to Health Canada which approach they will use. If they choose to include the internet address in their labelling materials, they will have to submit the adjusted labelling materials for review.
While not required for lab-based serological tests, manufacturers should include this information in their labelling.
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 requirements for serological antibody tests guidance and the notice on sensitivity and specificity values for COVID-19 serological testing devices, as well as the information above on submission requirements.
- 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 email@example.com.
For information about the licensing or authorization of medical devices in Canada, please contact the Medical Devices Directorate at firstname.lastname@example.org.
- Requirements for serological antibody tests submitted under the COVID-19 interim order - guidance document
- COVID-19 serological testing devices: Notice on sensitivity and specificity values
- COVID-19 medical devices
- List of testing devices for COVID-19: applications under evaluation
- Authorized medical devices for uses related to COVID-19
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