Question Period Note: COVID-19 test kits

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• Throughout the pandemic, Health Canada has ensured that testing devices authorized for sale in Canada meet safety, safety, effectiveness and quality requirements.
• Health Canada has one of the most highly regarded regulatory frameworks for medical devices in the world.
• Since the start of the pandemic, Health Canada put in place rapid, innovative and agile measures to ensure prompt access to medical devices to respond to the needs of Canadians.
• Health Canada’s consistent approach throughout the pandemic has ensured that the testing devices available in Canada have been high performing and reliable.
• Working with our public health partners, we have identified the following testing technologies as being of the highest priority for evaluation at this time:
- self-testing devices
- ‘multiplex’ devices that diagnose and differentiate between other respiratory viruses (e.g., Influenza A and B)
- point-of-care antigen or molecular testing devices that use nasal swab or saliva samples for use in symptomatic and asymptomatic populations administered by trained operators (rather than health care professionals)

IF PRESSED ON HEALTH CANADA’S POSITION ON THE EFFECTIVENESS OF COVID TESTS TO DETECT VARIANTS …
• Based on the information available to date on variants, the authorized tests continue to be effective.
• Health Canada is working proactively with manufacturers of approved COVID-19 test devices to assess the impact of novel variants of public health concern. Manufacturers that identify a concern about the performance of their test must report their concern to us. We will take any necessary action to mitigate any risks.

IF PRESSED ON HEALTH CANADA’S POSITION ON SALIVA TESTING FOR COVID-19…
• Health Canada has authorized a number of accurate and reliable COVID-19 test devices for use with various samples.
• At this time, Health Canada has authorized the use of gargle and spit samples for use with the authorized Cepheid Xpertxpress SARS-CoV-2 testing device
• Health Canada has also authorized 8 tests that utilize saliva samples.
• Health Canada is prioritizing the review of applications for test kits that use saliva samples so Canadians have access to new testing options.

IF PRESSED ON HEALTH CANADA’S POSITION ON BREATHALYZER TESTING FOR COVID-19…
• At this time, there are no COVID-19 breathalyzer testing devices currently permitted for sale or distribution in Canada.
• Health Canada is prioritizing the review of novel diagnostic technologies that may use less invasive sample types, such as breath.
• The Department continues to contact manufacturers of breathalyzer technologies to invite them to submit an application in Canada.

Under the Interim Order, manufacturers can submit an abbreviated application to support the safety, effectiveness and quality of their medical device. Fees associated with an application through the IO pathway are waived.

Health Canada has received applications for three types of testing devices:
1. Nucleic acid-based tests (detection of the viral genetic material)
2. Antigen-based tests (detection of proteins on the surface of the virus)
3. Serological-based tests (detection of antibodies)

Since the beginning of the pandemic, Health Canada has worked closely with public health partners to ensure that applications for COVID-19 testing devices are prioritized to meet urgent public health needs. Health Canada is currently prioritizing self-testing devices, ‘multiplex’ devices that diagnose and differentiate between other respiratory viruses (e.g., Influenza A and B) and tests that use less invasive sample types such as nasal swab or saliva samples.

Health Canada authorizes tests based on the data provided by the manufacturer. The manufacturer must provide sufficient data to support the intended use and claims being made, including the sensitivity established for the specific test.

Health Canada regulates the sale of medical devices in Canada — not their use.

Provinces and territories are responsible for the delivery and administration of health care services. Decisions on the use of medical devices, including “off-label use” of authorized testing devices, rests with provincial and territorial governments. If a test is used in an off-label manner, the performance characteristics (e.g. established sensitivity) of the device cannot be assured.
Health Canada has set minimum standards for sensitivity that a COVID-19 antigen test must meet for an authorization to be granted. Tests with sensitivity below this minimum threshold of 80% do not meet the criteria outlined in the Interim Order, and will not be authorized. Sensitivity values below this level produce too many false negative results.
To remain agile and allow flexibility, Health Canada will accept data to support serial testing protocols for use in asymptomatic populations.

• Santé Canada réglemente la vente d'instruments médicaux au Canada - et non leur utilisation. Santé Canada autorise les tests en fonction des données fournies par le fabricant. Le fabricant doit fournir des données suffisantes pour appuyer l'utilisation prévue et les allégations formulées, y compris la sensibilité établie pour le test en question.
• Les provinces et les territoires sont responsables de la prestation et de l'administration des services de soins de santé. La décision concernant l'utilisation d'instruments médicaux, y compris l'utilisation non indiquée sur l'étiquette d’instruments de dépistage autorisés, relève des gouvernements provinciaux et territoriaux.