Testing devices for COVID-19: Antigen testing devices
Find information on the requirements for getting medical devices authorized in Canada on the medical devices page.
Before submitting an 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
- Antigen testing
- Handling COVID-19 rapid tests safely
- Serial testing
- How to get an authorization
Antigen 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. These tests can be used by a health care professional or trained operator in a point-of-care setting, but lab-based antigen tests exist as well. Some antigen tests can also be used as a self-testing device outside of a professional setting. 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 continue to review antigen tests that meet an urgent public health need. Health Canada has authorized several antigen tests to date. See the list of authorized testing devices.
Using testing devices as directed
Always follow the instructions contained in your test kit or provided by your local health authority. The instructions are written specifically for that particular type of kit. If you take a sample in a different way, your test result may be invalid.
Get more information on our Authorized COVID-19 testing devices page.
Handling COVID-19 rapid tests safely
There may be potential risks associated with the misuse, accidental ingestion or spillage on the skin of COVID-19 rapid test kit solution.
Learn more about these risks and what to do.
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.
Based on the evolving science, Health Canada has updated its policy position on serial testing with antigen tests in symptomatic and asymptomatic populations.
For more information, please refer to our serial testing policy for antigen tests.
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 single-use components.
How to get an authorization
Before submitting an application, 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 of the Medical Devices Regulations (MDR) 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
Health Canada refers to guidance published by the U.S. Food and Drug Administration (FDA) on antigen detecting tests.
For antigen 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.
Please note that we have updated our policy position on serial testing indications. This notice complements the FDA's current position on serial testing.
Health Canada has additional labelling specifications relating to vaccinations and emerging variants of public health concern that are not included in the FDA guidance.
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 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 that conveys the same meaning:
“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 that submit evidence of their device's performance in specimens from individuals infected with emerging variants may be able to have this requirement adjusted.
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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