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?

• Health Canada understands the need to have a variety of test kits available for use to meet different public health needs
• The Department has prioritized the review of all types of COVID-19 tests, including rapid and new innovative testing options and technologies.
• Health Canada is working as quickly as possible to approve rapid, point-of-care diagnostic and monitoring tests based on nucleic acid and antigen technologies to meet Canadian testing needs without compromising on standards for safety, effectiveness and quality.
• Health Canada has authorized a variety of testing devices, including tests that can be used at a point of care and rapid tests, through an expedited regulatory review.
• A medical device is authorized only after a scientific assessment by Health Canada reviewers to ensure that it is supported by evidence showing it meets standards for safety and effectiveness.
• 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 our existing testing capacity.

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, including the recent authorization of the Abbott ID NOW COVID-19 test on September 30, 2020. Health Canada has received additional point-of-care nucleic acid-based tests which are being prioritized for review at this time.

1. Antigen-based tests (detection of proteins on the surface of the virus)

Antigen tests are rapid tests that can be offered at the point of care in disposable formats. Health Canada has authorized the sale of 3 antigen tests as of December 1, the Abbott Panbio, the BD VeritorTM and the Quidel Sofia. Antigen testing is one of several emerging technologies that can be used to determine if a person is infected with the COVID-19 virus.

1. 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.

SYNOPSIS

• On March 18, 2020, the Minister of Health approved an Interim Order (IO) to expedite the review of medical devices, including test kits.
IF PRESSED… on the authorization of “rapid tests”
• Health Canada is reviewing applications for many different technologies, including those that are able to return rapid results.
• Health Canada is reviewing applications for antigen tests that are all indicated for use in point-of-care settings, such as the doctor’s office or bedside.
• Health Canada is reviewing these applications as quickly as possible without compromising patient safety.
IF PRESSED… on the accuracy of the authorized antigen tests

• These tests provide preliminary test results only. There is the possibility of false-negative results, meaning that the patient may have COVID-19 even if the test result is negative.
• Negative results from this test are considered “presumptive”, which means that they cannot entirely rule out that the patient may be infected.
• Treatment decisions or the need for additional testing should be made in consultation with the patient’s healthcare provider and take into account whether symptoms are present or continue.
IF PRESSED… on how tests are deployed

• Scientists at Canada’s National Microbiology Laboratory (NML) are determining a national strategy to distribute point of care tests in the best way possible to meet the needs of those most at risk.
• The Public Health Agency of Canada (PHAC) distributes the testing devices based on a needs analysis—in coordination with provinces and territories and Indigenous Services Canada—to get devices to communities that are at greatest risk if there were to be an outbreak of COVID-19.
IF PRESSED… on Health Canada’s position on home testing for COVID-19:
• Health Canada is open to reviewing all testing solutions. This includes approaches that use self-collection or at-home test kits for screening purposes - to enable individuals with or without symptoms who wish to assess and monitor their own infection status.
• Health Canada has not yet received any applications for at-home test kits.
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 not authorized the use of saliva samples with any authorized testing device.
• Health Canada welcomes applications of test kits validated for use with saliva samples.
• Health Canada will prioritize the review of applications for test kits that use saliva samples in order to enable new testing options for Canadians.
IF PRESSED… on the British Columbia swish and spit lab tests:

• Health Canada and the Public Health Agency of Canada welcome all new technologies that will help in the fight and reduce the impact of COVID-19 on Canadians.
• Provincial/territorial laboratories can develop their own tests in-house and offer testing services. These tests and testing services are regulated under provincial or territorial jurisdiction.
• Laboratory developed tests and testing are not regulated by Health Canada - there is no sale of a device.
• Health Canada has not received any applications for a commercial swish and spit COVID-19 test.
IF PRESSED… on the accuracy of the test kits:
• Health Canada has maintained a science-informed approach to managing the pandemic.
• A medical device is authorized only after a scientific assessment by Health Canada to ensure that it is supported by evidence showing it meets standards for safety and effectiveness.
• As with all medical devices, Health Canada will assess and monitor the safety and effectiveness of the tests once they are on the market.
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 the authorization of Spartan test kits:
• Health Canada continues to work with Spartan in their efforts to produce the evidence required to demonstrate that their product functions appropriately.
• Health Canada has provided regulatory guidance to Spartan relating to the completion of clinical trials on their testing device and will prioritize the review of the application for authorization of the test when it is received.