Question Period Note: COVID-19 TEST KITS

• Throughout the pandemic, Health Canada has ensured that testing devices authorized for sale in Canada meet safety, effectiveness and quality requirements.

KEY MESSAGES
• 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.
• Health Canada has made it a priority to review applications for COVID-19 devices that meet an urgent public health need in Canada.
• As of the beginning of December, Health Canada has authorized over 94 testing devices, including 6 self-tests and 24 tests that can be used in a point of care setting.
• Working with our public health partners, we have identified the following testing technologies as being of the highest priority for evaluation at this time:
o self-testing devices
o ‘multiplex’ devices that diagnose and differentiate between other respiratory viruses (e.g., Influenza A and B)
o 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)
• As new tests become available and approved for use in Canada, the Public Health Agency of Canada works with provincial public health laboratories to acquire and distribute them to increase existing on-the-ground testing capacity.
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 monitoring the potential impact of the new variants, including the recently identified omnicron variant, on the effectiveness of test devices and will take action as necessary.
IF PRESSED ON HEALTH CANADA’S POSITION ON HOME TESTING FOR COVID-19 …
• Applications for self-testing technologies are the highest priority for review at this time.
• As of December 2, Health Canada has authorized six self-tests.
• The Department continues to contact manufacturers of self-tests that have been authorized in other jurisdictions to invite them to submit an application in Canada. As of December 2, 6 self-tests are currently under review by Health Canada.
IF PRESSED ON HEALTH CANADA’S POSITION ON ASYMPTOMATIC TESTING FOR COVID-19…
• Since May 2021, Health Canada has authorized 13 tests to allow for testing in asymptomatic populations.
IF PRESSED ON WHY TESTS ARE AUTHORIZED IN OTHER COUNTRIES BUT NOT IN CANADA …

• Each jurisdiction has different rules and approval processes.
• Once tests are approved by international partners, we contact manufacturers to encourage them to apply for authorization in Canada.
• Health Canada accepts submissions made to another jurisdiction and assesses that data independently.
• Health Canada’s consistent approach throughout the pandemic has ensured that the testing devices available for sale in Canada have been accurate and reliable.
• We have avoided some of the problems other countries have experienced, including recalling lower-quality tests.
• Canada is one of the few countries with minimal post-market issues, including recalls.
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 the Norgen Biotek 2019-NCOV N Gene and Norgen Biotek COVID-19 E/RDRP Genes, which both 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.

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.

KEY FACTS

• 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.
• 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.