COVID-19 for health professionals: Testing, diagnosis and case reporting
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Canada is working with companies that are developing new and innovative testing technologies. We are also engaging with international regulators to share knowledge about new developments related to testing.
Before testing devices are authorized for sale in Canada, Health Canada assesses their safety, effectiveness and quality. For a test to be authorized by Health Canada, it must be submitted for review by the manufacturer.
Health Canada regulates the sale and import of commercial testing devices relating to COVID-19.
Most submissions to Health Canada are for 3 types of commercial testing devices:
- nucleic acid-based testing
- antigen-based testing
- serology-based testing
Consult the list of testing devices that have been authorized to date for use related to COVID-19.
Only testing devices authorized by Health Canada can be imported or sold in Canada. Unauthorized tests may not produce accurate results, leading to potential misdiagnosis. COVID-19 tests are confirmed to be well supported by evidence indicating they will provide accurate and reliable results.
Our National Microbiology Laboratory (NML) helped develop and verify the laboratory tests used to identify COVID-19. NML has worked closely with provinces and territories through the Canadian Public Health Laboratory Network to advance testing capacity in Canada. Additionally, NML scientists continue to investigate novel technologies to detect COVID-19, which can potentially enhance access to testing and increase ease of collection.
Serological tests do not detect the virus itself. Instead, they detect the antibodies produced in response to an infection. Serology tests are also known as antibody tests. Health Canada has published a resource on information for patients on COVID-19 serology testing.
We do not accept reports from the public or individual health care providers. Reporting is completed by provincial or territorial health authorities.
The Public Health Agency of Canada (PHAC) collaborates with provincial and territorial public health partners to collect information on COVID-19 cases in Canada. A detailed epidemiologic summary is available online for review.
Recommendations to public health care professionals
- Use the interim national case definition for COVID-19 to consider the possibility of COVID-19 in persons with relevant clinical and exposure history.
- Use the COVID-19 case report form (PDF) to facilitate case reporting of confirmed and probable COVID-19 cases.
- Provincial and territorial public health authorities should report confirmed and probable COVID-19 cases to PHAC within 24 hours of their own notification.
- PHAC must report events that meet the requirements for the International Health Regulations, Articles 6 and 7, to the World Health Organization (WHO) within 24 hours of assessment of public health information.
- Follow the guidance on the public health management of cases and contacts associated with COVID-19.
Increasing supply and distribution
Governments at the federal, provincial and territorial levels each play important roles in COVID-19 testing. The federal government has provided billions of dollars to help provincial and territorial governments:
- conduct testing
- perform contact tracing
- share public health data that will help fight the pandemic
The Government of Canada is closely monitoring the genetic variants of the virus that cause COVID-19. We are working with international partners, including the WHO, to better understand these variants and their impact.
PHAC has established definitions for COVID-19 variants. This will help Canadian public health experts use a common set of terms to facilitate common understanding and action across Canada.
- Polymerase chain reaction (PCR) and cycle threshold (Ct) values in COVID-19 testing
- National surveillance for Coronavirus disease (COVID-19)
- Interim national surveillance guidelines for human infection with COVID-19
- Guidance for repeated polymerase chain reaction testing in individuals previously positive for COVID-19
- Interim guidance on the use of rapid antigen detection tests for the identification of SARS-CoV-2 infection
- Pan-Canadian COVID-19 testing and screening guidance
- National polymerase chain reaction testing indication guidance for COVID-19
- Requirements for serological antibody tests submitted under the COVID-19 interim order
- COVID-19 health product advisories
- Biosafety advisory: SARS-CoV-2 (severe acute respiratory syndrome-related coronavirus 2)
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