Testing devices for COVID-19: Overview

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Access to testing devices for COVID-19

Early diagnosis is critical to slowing and reducing the spread of COVID-19 in Canada. Health Canada regulates the sale and import of medical devices, including commercial testing devices relating to COVID-19. As part of the government’s broad response to the pandemic, Health Canada introduced a number of agile regulatory measures to expedite the regulatory review of COVID-19 health products without compromising safety, efficacy and quality standards.

We are committed to getting Canadians access to the tools they need to fight the spread of COVID-19 in Canada. We have authorized a number of COVID-19 tests and continue to expedite the review of testing device submissions.

As the pandemic evolves, we are continuously updating our guidance and positions in light of the new scientific information available to us. We are open to reviewing all testing solutions as they become available. This includes:

Only testing devices authorized by Health Canada can be imported or sold in Canada. Unauthorized tests may not produce accurate results. This can lead to potential misdiagnosis. Health Canada confirms that authorized COVID-19 tests are well supported by evidence that indicates they will provide accurate and reliable results.

The performance of authorized COVID-19 testing devices has not been assessed in people who are vaccinated against COVID-19. However, Health Canada  does not expect intramuscular COVID-19 vaccinations to interfere with the performance of authorized COVID-19 nucleic-acid or antigen-based testing devices.

Tests that identify antibodies to the spike protein of the SARS-CoV-2 virus, however, 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.

Genetic variations of viruses such as the one that causes COVID-19 are not uncommon. The Government of Canada is closely monitoring the genetic variants of the virus that causes COVID-19. This includes not only those identified in the UK, South Africa but also any potential future variants.

Immediately upon learning of the emerging COVID-19 UK and South Africa variants, Health Canada took action to contact all manufacturers of authorized testing devices and request an analysis of the expected impact of these variants on their test’s performance. 

The analyses indicate that all authorized tests are expected to continue to perform and will show positive results for individuals infected with the new variants.  Health Canada will continue to monitor the potential impact of future variants and if an issue is identified, Health Canada will work quickly with manufacturers and public health laboratories to mitigate those risks.

Oversight of lab-developed tests

Health Canada doesn’t regulate lab-developed tests. These tests are different from commercial lab tests. The labs create the tests themselves, while manufacturers make commercial tests and then sell them to public and private labs to use. Sometimes, labs use both commercial and lab-developed tests to produce test results.

Provinces and territories are responsible for the delivery and administration of health care services, including public and private lab-developed tests. They can develop their own sample collection and testing methods for COVID-19. They are responsible for ensuring that these tests provide accurate and reliable results, which includes making sure that both the tests and collection methods are safe and effective.

Lab-developed testing is how all initial diagnostic testing for COVID-19 in Canada was accomplished. Canada's National Microbiology Laboratory (NML) developed a nucleic acid-based testing method and then validated that the test would produce reliable and accurate results. The NML shared this method with other public health laboratories across Canada so that they too could use it.

Lab-developed nucleic-acid tests make use of machines (called thermocyclers) that are commercially available. Health Canada doesn’t regulate the use of those machines in lab-developed tests. Labs that use these machines for diagnosis are responsible for validating their results in accordance with the requirements of their jurisdiction.

Types of testing devices for COVID-19

Most submissions to Health Canada are for 3 types of commercial testing devices:

There are different ways that samples can be collected to test for COVID-19. They can be collected by a health care professional or, in some instances, by the patient (self-collection), through a:

For more information on the requirements for classifying and authorizing nose and throat swabs, please consult the guidance on test swab safety and effectiveness. Saliva collection devices are generally classified as Class I devices. For more information on the requirements for classifying and authorizing these devices, please consult medical devices related to COVID-19.

Each testing device must indicate in the instructions for use the type(s) of sample collection that can be used with the device. Manufacturers must provide evidence in their submission to demonstrate the device can provide accurate results with the specified sample collection method(s). 

Similarly, the instructions for use must indicate the intended user (for example, lab staff, health care professional, general public), which also determines the intended settings (for example, lab, doctor’s office, pharmacy, bedside, home).

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 labs in Canada and around the world use nucleic acid-based testing to diagnose COVID-19 infection. This test is the gold standard for diagnosing active COVID-19 infection in patients with symptoms.

Like most jurisdictions, early in the pandemic, Health Canada prioritized the authorization of diagnostic tests using nucleic acid technology. We did this to increase the number of testing devices available in Canada to diagnose active and early-stage infections of COVID-19. Most nucleic acid tests are authorized for use in a lab, but recent focus has been on increasing the availability of nucleic acid tests for use at point of care. We’re prioritizing the review of point-of-care nucleic acid-based tests intended to diagnose COVID-19. 

For more information, please consult nucleic acid-based testing devices for COVID-19. This page includes links to specific guidance for nucleic acid-based testing device applications.

Antigen-based testing

Antigen-based 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. In general, antigen tests are designed to be used at point of care by a health care professional or trained operator, but lab-based antigen tests also exist.

We are prioritizing the review of point-of-care antigen-based tests intended to diagnose COVID-19 and have authorized several tests. 

For more information, please consult antigen testing devices for COVID-19. This page includes links to specific guidance for antigen-based testing device applications.

Serological (antibody) testing

Serological tests do not detect the virus itself. Instead, they detect the antibodies produced in response to an infection.

These 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. 

For more information on serology testing device authorizations, please consult serological testing devices for COVID-19. This page includes links to specific guidance for serological testing device applications.

For more information on how serological testing is being used in Canada, please consult the Public Health Agency of Canada’s (PHAC) webpage on serology testing.

List of applications under evaluation

Health Canada publishes a list of applications for testing devices that are currently under evaluation. This list provides information on the products that have been submitted to Health Canada for authorization. These applications for testing devices are complete and ready for scientific review. The applicant has agreed they can be made public.

Health Canada has not authorized the testing devices on this list. The Food and Drugs Act prohibits the sale or importation of these devices until an authorization or licence has been issued.

Being on the list of applications does not guarantee that Health Canada will authorize a product.

We will only discuss details of an application with an authorized representative of the applicant.

How to get authorization

Health Canada is open to reviewing all testing device submissions and encourages applications for innovative testing technologies. Currently, we are prioritizing the review of:

We encourage manufacturers to submit an application under the interim order for importing and selling medical devices related to COVID-19. This is the most effective pathway for manufacturers wanting to apply for authorization for COVID-19 test devices. As part of the application, manufacturers are required to explain the safety, effectiveness and quality of their medical device. We are waiving the fees for these applications.

To submit an application for authorization, follow these 4 steps:

  1. Review the guidance document on how to apply for medical devices for use in relation to COVID-19, under the interim order.
  2. If you are submitting an application for one of the following test-related devices, make sure to review the specific information provided for each of these devices:
  3. Prepare your submission package. Each submission must include enough information, including relevant data and device labelling, so that Health Canada can authorize the device.
  4. Submit your application to the Medical Devices Directorate at hc.devicelicensing-homologationinstruments.sc@canada.ca.

For information about the licensing or authorization of medical devices in Canada, please contact the Medical Devices Directorate at hc.meddevices-instrumentsmed.sc@canada.ca.

Health Canada works closely with PHAC’s National Microbiology Lab (NML). We may ask the NML to conduct an independent scientific evaluation of some COVID-19 testing devices to support decision-making. We will notify the manufacturer if its testing device is referred to the NML.

The manufacturer is still obligated to provide Health Canada with enough information about the quality, safety and effectiveness of the testing device to determine whether to authorize or license the device.

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