Testing devices for COVID-19: Point-of-care and self-testing devices
Health Canada has updated the list of COVID-19 testing devices that no longer have an urgent public health need status. Before submitting an IO application, please consult Medical devices no longer considered to have urgent public health need status: Notice to industry.
On this page
- About near patient in vitro diagnostic devices
- Recommendations by public health authorities on point-of-care testing
- How to get authorization
To expedite the review of medical devices that could be used to treat or diagnose COVID-19, the Minister of Health approved an interim order (IO) for importing and selling medical devices on March 18, 2020 and a second Interim Order (IO No. 2) on March 1, 2021. A third Interim Order was introduced on February 21, 2022 and replaced the IO No. 2 so that authorized COVID-19 medical devices can continue to be sold and imported in Canada due to the new highly transmissible and virulent SARs-CoV-2 variants. An IO is one of the fastest mechanisms available to address large-scale public health emergencies.
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 already been infected
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.
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 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 the IO, manufacturers may seek authorization for these devices. 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 authorization for more information on submission requirements for point-of-care testing devices for COVID-19.
Individuals with or without symptoms can use self-testing kits to assess and monitor their own infection status. Health Canada has identified self-testing technologies as a high priority. We welcome new applications for self-tests, as well as applications amending authorized tests to include this new indication.
The health and safety of Canadians 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.
World Health Organization
In September 2020, the World Health Organization (WHO) provided interim guidance on the role of antigen-detecting rapid diagnostic tests for COVID-19 detection.
The WHO noted that the ease-of-use and rapid turnaround time of antigen-based tests offers the potential to expand access to testing and decrease delays in diagnosis. However, antigen-based tests have a lower sensitivity for detecting the virus compared to nucleic acid-based (molecular) tests. The WHO outlines specific situations where antigen-based tests should not be used, based on currently available information.
The WHO doesn’t recommend antigen-based tests:
- for people without symptoms unless the person is a contact of someone diagnosed with COVID-19
- where there are zero or only sporadic cases (not recommended for routine surveillance as positive test results would likely be false positives)
- for airport or border screening at points of entry (positive and negative results
Please review the WHO guidance for other recommendations on the use of antigen-based tests for COVID-19. The WHO continues to monitor the situation closely for any changes that may affect this interim guidance. Should any factors change, it plans to issue a further update.
How to get authorization
The Interim Order No. 3 to import and sell medical devices related to COVID-19 allows Health Canada to carry out expedited evaluations of applicable applications. A first interim order was introduced to that effect on March 18, 2020. The second interim order was introduced on March 1, 2021 and replaced the first one. The third interim order was introduced on February 21, 2022 and replaced the second one. 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.
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
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 relevant requirements for near patient IVDDs as outlined above.
- 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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