Testing devices for COVID-19: Serological testing devices
Before submitting an IO application for authorization under Part 1.1 of the Medical Devices Regulations, please consult the List of Medical Devices for an Urgent Public Health Need in Relation to COVID-19.
On this page
- Serological tests
- Understanding serological testing results
- Serological point-of-care testing
- How to get an authorization
Serological tests (also known as antibody tests) do not detect the virus itself. Instead, they detect the antibodies produced in response to a previous infection by SARS-CoV-2 virus or in response to vaccination. Serological tests are not appropriate for diagnosing COVID-19 and do not indicate if you have immunity.
Health Canada has authorized the sale of serological tests used to detect 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 page on serology testing.
Understanding serological testing results
Health Canada has published a resource on Information for patients on COVID-19 antibody (serology) testing.
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.
Variants of a virus are versions of the virus in which the nucleic acids are different. Variants can affect the performance of a test. A false negative result can occur with any test. However, the test is more likely to give a false negative result if what it detects is changed as a result of the differences in the variant.
The impact of variants on each test will depend on:
- what has changed, whether only the nucleic acids or also the antigens and antibodies
- whether the test detects nucleic acids, antigens or your antibodies
- if the test detects more than one part of the virus
- since variants are expected, some tests are designed to detect more than one part of the virus
A negative test result should be considered along with a person’s symptoms, history of exposure to the virus and the variant of virus that is common in their area.
Given that virus variants are common and expected, Health Canada continues to review available information. We work with other regulators and manufacturers of COVID-19 test devices to monitor any impact that variants may have on the ability of diagnostic tests approved by Health Canada to detect COVID-19 variants. If an issue is identified, we will work quickly with manufacturers and public health laboratories to mitigate those risks.
Health Canada encourages manufacturers to consider using recycled/recyclable, reusable, compostable and sustainable materials when developing test devices. For instance, manufacturers could consider using recycled/recyclable packaging materials and inserts and/or reducing one-time use testing components for self-tests.
Serological point-of-care testing
The Canadian Public Health Laboratory Network released a statement on point-of-care serology testing for COVID-19 in May 2020. It recommended that serology tests could be used to inform public health responses. However, at this time, near patient serological assays for SARS-CoV-2 shouldn’t be used for clinical testing.
Based on this information, we will not accept amendment applications to add point-of-care claims to serology tests that have already been authorized by Health Canada.
How to get an authorization
Before submitting an application under Part 1.1 of the Medical Devices Regulations (MDR), manufacturers should consult the List of Medical Devices for an Urgent Public Health Need in Relation to COVID-19 (UPHN list). An application can only be submitted under Part 1.1 for a device in Part 1 of the UPHN list or a device that belongs to a category of devices that is in Part 2 of the UPHN list.
For information on how to apply for medical devices for use in relation to COVID-19 under Part 1.1 of the MDR, please consult the following guidance document:
Additional submission requirements
For serological test requirements, please consult the following:
- Guidance on the requirements for serological antibody tests
- Notice on sensitivity and specificity values for COVID-19 serological testing devices
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 who 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.”
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 this test was established based on the evaluation of a limited number of clinical specimens. Clinical performance has not been established with all circulating variants but is anticipated to reflect the prevalent variants in circulation at the time and the location of the clinical evaluation. Performance at the time of testing may vary depending on the variants circulating, including newly emerging strains of SARS-CoV-2 and their prevalence, which change over time.”
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.
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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