Question Period Note: COVID-19 Test Kits

·       What is Health Canada doing to ensure Canada has access to the rapid testing devices needed during the COVID-19 pandemic?

KEY MESSAGES
• The Department has prioritized the review of all types of COVID-19 tests, including rapid and new innovative testing options and technologies.
• Health Canada continues to work as quickly as possible to approve rapid, point-of-care diagnostic, self-testing and monitoring tests without compromising on standards for safety, effectiveness and quality.
• As of June 14, 2021, Health Canada has authorized 74 testing devices, through its expedited regulatory review efforts. This includes rapid tests, that can be used at home or in a point of care setting.
• On April 23, Health Canada authorized the first self-test kit, the Lucira CHECKIT COVID-19 Test Kit. Since then Health Canada continues to proactively contact self-test manufacturers that have been authorized in other jurisdictions; inviting them to submit an application in Canada.
• On May 12, Health Canada authorized an amendment to the Quidel Sofia, a rapid antigen test, to allow for serial testing in asymptomatic populations.
• 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.
• Based on the information available to date on variants, the authorized tests continue to be effective.
• Health Canada is monitoring the potential impacts of the new variants 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:
• Health Canada has identified applications for self-testing technologies as being of highest priority for review at this time.
• On April 23, 2021, Health Canada authorized the Lucira CHECKIT COVID-19 Test Kit. This is the first complete self-test kit to be authorized in Canada.
• The single-use test kit uses self-administered nasal swabs and results are available within 30 minutes.
• A second application for a self-testing device is currently under priority review - this device is the “Panbio COVID-19 Antigen Self-test”.

IF PRESSED… on why tests are authorized in other countries but not in Canada

• Each jurisdiction has different rules and approval processes.
• Health Canada’s consistent approach throughout the pandemic has ensured that the testing devices available for sale in Canada have been accurate and reliable. As a result, we have avoided some of the problems other countries have experienced, including recalling lower-quality tests.
• Health Canada accepts submissions made to another jurisdiction and assesses that data independently.
• Once tests are approved by our international partners, we contact manufacturers to encourage them to apply for authorization in Canada.

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 tests 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 is prioritizing the review of applications for test kits that use saliva samples so Canadians have access to new testing options.
IF PRESSED… on the authorization of Spartan test kits:

• Health Canada authorized the Spartan Biosciences COVID-19 test kit under an Interim Order on January 22, 2021.
• When Health Canada became aware of reports of inaccurate results from users of the Spartan Biosciences COVID-19 tests, the Department requested detailed information from Spartan about the nature of the inaccuracies, possible causes, and where the tests have been distributed.
• On March 30, 2021, Spartan initiated a voluntary recall and contacted their customers to notify them of the issue.
• Spartan continues to investigate the root-cause of the performance issue, keeping Health Canada informed. Upon completion of this investigation, Health Canada will review the analysis before distribution re-commences.

BACKGROUND
Early diagnosis and isolation of patients infected with COVID-19 are essential to slowing the spread of the novel coronavirus across Canada. Diagnostic testing is important for clinical care and public health management.
Under the IO, manufacturers must 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)
Public health laboratories across Canada and around the world use nucleic acid-based testing to reliably diagnose COVID-19 infection by detecting the virus itself. A number of lab-based and point-of-care nucleic acid-based tests have been authorized for use in Canada. Health Canada has received additional point-of-care nucleic acid-based tests which are being prioritized for review at this time.
2. Antigen-based tests (detection of proteins on the surface of the virus)
Antigen tests are often rapid tests that can be offered at the point of care in disposable formats, though one lab-based antigen test has been approved as well. Antigen testing is one of several emerging technologies that can be used to determine if a person is infected with the COVID-19 virus.
3. Serological-based tests (detection of antibodies)
Serologic tests detect the antibodies developed against the virus. Health Canada is not aware of a serological-based test that can diagnose COVID-19. Serological tests are not appropriate for early diagnosis of COVID-19, given the time required after infection to develop antibodies.

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