Testing devices for COVID-19: Nucleic acid testing devices
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Nucleic acid-based testing
Nucleic acid-based testing is also called molecular testing, and is often called PCR. Molecular tests detect the virus genetic material (nucleic acids). Public health laboratories in Canada and around the world use nucleic acid-based testing to diagnose COVID-19 infection. This test is the gold standard to diagnose active COVID-19 infection in patients with symptoms.
For more information on cycle threshold values and use in nucleic acid tests, consult the polymerase chain reaction (PCR) and cycle threshold (Ct) values in COVID-19 testing page.
We have authorized a number of diagnostic tests using nucleic acid technology, both for use in the lab and at point-of-care, to increase the number of devices in Canada to detect active infections of COVID-19. We are prioritizing the review of point-of-care nucleic acid-based tests. Consult the list of authorized testing devices.
We currently have no evidence that variants affect the ability of diagnostic tests approved by Health Canada to confirm COVID-19 cases. We are working with other regulators and manufacturers of COVID-19 test devices to assess the impact of variants. If there’s an issue, we will act quickly and keep you informed.
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.
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. 2. 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. 2 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 nucleic acid-based tests:
- for testing devices intended for laboratory or point-of-care use, please refer to FDA’s guidance on molecular tests
- for testing devices intended for self-testing, please review the FDA guidance for molecular and antigen tests for non-laboratory use
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 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
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.
In light of 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 clearly stated.
- 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.
Manufacturers that submit evidence on how their device performs in specimens from people 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 nucleic acid-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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