Testing devices for COVID-19: Nucleic acid testing devices
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.
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Nucleic acid testing
Nucleic acid testing is also called molecular testing, and is often called PCR. These 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 have also authorized nucleic acid self-tests for use outside of a professional setting.
We continue to review nucleic acid tests that meet an urgent public health need.
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 the use of recycled/recyclable packaging materials and inserts and/or reducing one-time use testing components for self-tests.
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 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 refer to FDA's 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 an additional labelling specification relating to emerging variants of public health concern that is 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.
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 we can authorize an application:
- 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.
For information about the licensing or authorization of medical devices in Canada, please contact the Medical Devices Directorate at firstname.lastname@example.org.
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