Testing devices for COVID-19: Overview
On this page
- Access to testing devices for COVID-19
- Types of testing devices for COVID-19
- List of applications under evaluation
- How to get an authorization
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 related to COVID-19. As the pandemic evolves, we are continuously updating our guidance and positions in light of new scientific information.
We are committed to getting people in Canada access to the tools they need to fight the spread of COVID-19. We continue to review testing devices that address an urgent public health need.
Health Canada has authorized a variety of COVID-19 tests based on data supporting their intended use. This includes:
- lab-based tests (samples are collected and sent to a laboratory for analysis)
- point-of-care tests (sample collection and testing is done at the place of care, such as a doctor's office, and results are provided while you wait)
- self-testing devices that allow individuals with or without symptoms to assess and monitor their own infection status (for example, by testing at home without the supervision of a health care professional)
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.
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.
Factors to consider when using COVID-19 testing devices
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
- if 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.
COVID-19 "for research use only"
Health Canada has received questions about the use of the term "for research use only" related to COVID-19 testing devices.
Labelling a product "For Research Use Only" applies only to a medical device in the research phase of development. A commercial medical device is not considered to be in the "research phase" of development if it:
- has validated performance characteristics
- has instructions-for-use documents citing performance claims or
- is under review for regulatory approval by Health Canada (or another regulatory jurisdiction)
During the course of scientific evaluation, Health Canada considers exceptions:
- for the purposes of validating use of the test in a lab environment prior to procurement and/or
- as a direct result of a request we make for samples
In these cases, the device can be imported and distributed to the public health laboratory using "For Research Use Only" labelling.
Consult the notice on research use only labelling for more information.
Oversight of lab-developed tests
Health Canada doesn't regulate lab-developed tests. These tests are different from commercial lab tests. The labs themselves create lab-developed tests. 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 delivering and administering 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
Health Canada has authorized 3 types of testing devices:
- nucleic acid tests
- antigen tests
- serology tests
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:
- nose swab
- throat swab
- oral (fluid) swab
- saliva sample
- blood draw
Health Canada doesn't regulate who can collect a sample from a patient. Provinces and territories are responsible for delivering and administering health care services, including the collection of samples from patients.
In the case of a lab-based or point-of-care test, Health Canada receives evidence showing that the test performs adequately after an appropriate sample has been collected. We generally do not assess the process involved in collecting samples. Sample collection is evaluated for self-collection and self-testing devices.
This also applies to point-of-care devices that are authorized for use by trained operators. In such instances, Health Canada has not necessarily received evidence that a trained operator can collect the sample. We have only evaluated evidence that the trained operator can conduct the test once the sample has been collected. Exceptions are made for tests that use an unusual or proprietary sample collection device or devices that require the collection of finger-stick capillary blood.
For a Class I swab/funnel specimen collection device where a manufacturer seeks Health Canada pre-market authorization, we evaluate evidence from clinical feasibility studies that involve sample collection by a trained health care professional. We do not assess the collection of nose or throat swabs by individuals other than trained health care professionals. The quality of the sample is important, as improper sampling or an inadequate sample volume may affect the clinical performance of any test.
For more information on the requirements for classifying and authorizing nose and throat swabs, please consult:
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 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 labs in Canada and around the world use nucleic acid 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. We have authorized a number of diagnostic tests using nucleic acid technology, for use in the lab and at point-of-care, to increase the number of devices that can 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.
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 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. We have authorized a number of antigen tests that are designed to be used in a lab or in point- of- care settings by a health care professional or for self-testing.
We continue to review antigen tests that meet an urgent public health need.
For more information, please consult:
- Antigen testing devices for COVID-19 for links to specific guidance for antigen-based testing device applications
- Information for patients: A guide to self-testing for COVID-19
Serological (antibody) tests
Serological tests do not detect the virus itself. Instead, they detect the antibodies produced in response to an infection. Antibodies may be developed 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 protective immunity. Serology tests are also known as antibody tests.
Health Canada has authorized the sale of serological testing devices used to detect 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 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.
To submit an application for authorization, follow these 4 steps:
- Review the Medical devices for use in relation to COVID-19 guidance document on how to apply for medical devices for use in relation to COVID-19, under Part 1.1 of the MDR.
- If the device you are submitting an application for is on the UPHN list and is one of the following test-related devices, make sure to review the specific information provided for each of these devices:
- Prepare your submission package as described in the guidance document.
- 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.
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.
We encourage all manufacturers to make their devices useable by persons with disabilities. Features, components and capabilities could include:
- alternative formats for instructions and results, such as:
- large print
- audio cues
- accessible packaging features for clients with a motor impairment
We currently prioritize review of COVID-19 testing technologies that feature accessibility functionalities for persons with disabilities. We will review and advance new applications and amendments to previous applications as quickly as possible in accordance with Canadian public health priorities.
Through an environmental scan in September 2022, the Canadian Agency for Drugs and Health Technologies identified several gaps in the testing of people across Canada for COVID-19. This includes challenges related to broad community accessibility.
Health Canada uses findings like these along with information from our public health partners to adjust our UPHN list. We are committed to working with public health partners and other key stakeholders to ensure that our priorities continue to reflect the urgent public health needs of people living in Canada.
Read the full report:
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