Testing devices for COVID-19: Point-of-care and self-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
- About near patient in vitro diagnostic devices
- Recommendations by public health authorities on point-of-care testing
- How to get an authorization
About near patient in vitro diagnostic devices
A near patient in vitro diagnostic device (IVDD) is used for:
- point-of-care testing in a health care setting (for example, doctor’s office, pharmacy, at the bedside) or
- self-testing (for example, used by individuals at home)
Typically, these rapid test devices are simple to use and provide visual or simple results within a short time.
A near patient IVDD used for COVID-19 could include:
- a device that can detect the presence of RNA from the SARS-CoV-2 virus that causes COVID-19 (nucleic acid-based testing) or its antigens (antigen-based testing) or
- a serological test that can detect the presence of antibodies developed against the virus in the blood of people who have been infected or vaccinated
To be useful in reducing the spread of COVID-19, near patient IVDDs must produce accurate and reliable results. It’s also critical to make the test results available to health authorities so they can connect patients to medical care and provide guidance to prevent transmission of additional infections.
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 care professionals use near patient IVDDs at the point of care so they can provide immediate results to their patients. Doing so can enable timely treatment, assist in disease surveillance, prevent transmission events or help to contain infectious disease outbreaks.
Under Part 1.1 of the Medical Devices Regulations (MDR), an application can only be submitted by a manufacturer for a device in Part 1 of the List of Medical Devices for an Urgent Public Health Need in Relation to COVID-19 (UPHN list) or a device that belongs to a category of devices that is in Part 2 of the UPHN list. Manufacturers must ensure that performance claims are supported by studies carried out:
- for the intended users
- in the intended setting and
- under the intended conditions of use
Review how to get an authorization for more information on submission requirements for point-of-care testing devices for COVID-19.
Self-testing allows people to test themselves or their dependants for SARS-CoV-2, the virus that causes COVID-19.
We continue to review self-tests that meet an urgent public health need.
The health and safety of people in Canada is our priority. Before a product is authorized for use in Canada, it’s assessed thoroughly through our regulatory process. This ensures products are supported by sufficient evidence of safety, effectiveness and quality.
Review how to get authorization for more information on submission requirements for self-testing devices for COVID-19.
Recommendations by public health authorities on point-of-care testing
Recommendations related to testing have continued to evolve as we learn new information about the COVID-19 virus and as new tests and technologies come to market.
Pan-Canadian COVID-19 testing and screening guidance
The Pan-Canadian COVID-19 testing and screening guidance published in October 2020 provides recommendations on using different types of testing technologies for various purposes (diagnostic, screening and surveillance) within Canada. This guidance focuses mainly on lab-based testing. Although molecular (PCR) laboratory testing is the gold standard in diagnostic testing, numerous technologies and testing methods are emerging that could supplement diagnostic testing. This includes technologies for use at point of care.
National Microbiology Lab
In addition, the Public Health Agency of Canada’s National Microbiology Lab (NML) published an interim guidance on antigen testing in October 2020. This guidance provides information on the use of rapid antigen detection tests (RADT) for use at point of care, outside of the lab environment. It highlights the importance of identifying scenarios where the use of RADTs may further strengthen the public health response, by expanding access to testing outside of traditional labs.
A proposed framework for implementing these tests is provided in the interim guidance. The NML indicates that these tests are ideally used in a program where people get repeat tests.
The proposed framework includes a number of suggestions. For example, the framework suggests considering:
- positive results from RADTs as a "presumptive positive" case until a reference nucleic acid-based (PCR) method confirms the positive result
- the clinical context of the test (asymptomatic as opposed to symptomatic) and the pre-test probability of infection in the person tested when interpreting a negative RADT
- further testing using a nucleic acid-based (PCR) reference method for patients with negative RADT results where the pre-test probability of COVID-19 remains high (for example, a known contact, high community transmission), to direct further management
- if the pre-test probability is low, then the person can be monitored and remain out of isolation
As the NML guidance indicates, these new tests are still being investigated, and their performance characteristics are not yet fully understood. Viral loads, which are generally high in early disease, are sufficiently above the limit of detection for some antigen tests for the first 5 days of symptoms. After this initial period, performance decreases rapidly as the viral load starts to decrease.
Potentially beneficial characteristics include:
- faster turnaround time
- a lower per-test cost
- the ability for non-professionals to do the test
These characteristics suggest that antigen tests will have an important role to play in the next phase of the response.
Canadian Public Health Laboratory Network
The Canadian Public Health Laboratory Network released a statement on point-of-care serology testing for COVID-19 in May 2020. It recommended that serology tests could be used to inform public health responses. However, near patient serological assays for SARS-CoV-2 shouldn’t be used for clinical testing in any capacity at this time.
How to get an authorization
Before submitting an application under Part 1.1 of the Medical Devices Regulations (MDR), 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. 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
Manufacturers must ensure that performance claims are supported by studies carried out:
- for the intended users
- in the intended setting and
- under the intended conditions of use
For tests designed for point of care or self-testing, this means conducting a study to demonstrate that users can use the device safely and effectively according to the instructions for use.
Health Canada refers to guidance published by the U.S. Food and Drug Administration (FDA) for point-of-care testing and self-testing kits. This guidance may be an addendum to requirements established for molecular and/or antigen-based tests. Please review our instructions related to these technologies to ensure your application is complete.
For point-of-care indications:
For self-testing indications:
Health Canada expects manufacturers following the FDA guidance for molecular and antigen tests for non-laboratory use to follow the guidance provided for non-prescription testing. This is because the distinction made by the FDA between prescription and non-prescription testing doesn’t exist in Canada.
The FDA guidances are in a template format and outline requirements that these products must meet.
For more information on Health Canada’s standard guidance for each of these specific technologies, please consult their respective pages.
- Testing devices for COVID-19: Nucleic acid testing devices
- Testing devices for COVID-19: Antigen testing devices
For information about the licensing or authorization of medical devices in Canada, please contact the Medical Devices Directorate at firstname.lastname@example.org.
- Date modified: