Testing devices for COVID-19: Point-of-care and self-testing devices

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Background

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 for importing and selling medical devices. This interim order (IO), signed on March 18, 2020, 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:

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:

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.

Point-of-care testing

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:

Review how to get authorization for more information on submission requirements for point-of-care testing devices for COVID-19.

Self-testing

To date, Health Canada has authorized the sale and importation of COVID-19 tests only for use by health care professionals or trained operators. However, we are open to reviewing all testing solutions. This includes approaches that use self-testing kits, to enable individuals with or without symptoms to assess and monitor their own infection status.

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:

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:

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:

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 to import and sell medical devices related to COVID-19 allows Health Canada to carry out expedited evaluations of applicable applications. 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.

Submission requirements

Manufacturers must ensure that performance claims are supported by studies carried out:

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 US Food and Drug Administration (FDA) for point-of-care testing and self-testing kits.

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. 

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. Review the relevant requirements for near patient IVDDs as outlined above.
  3. 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.
  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.

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