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Nucleic acid-based testing is also called molecular testing, and is often called PCR. Molecular tests detect the virus genetic material (nucleic acids). Public health laboratories in Canada and around the world use nucleic acid-based testing to diagnose COVID-19 infection. This test is the gold standard to diagnose active COVID-19 infection in patients with symptoms.
The purpose of this notice is to communicate minimum values of sensitivity for COVID-19 antigen testing devices.
The purpose of this notice is to communicate minimum values of sensitivity for COVID-19 antigen testing devices.
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. Serological tests are not appropriate for diagnosing COVID-19.
A near patient in vitro diagnostic device (IVDD) is used for: point-of-care testing in a health care setting (for example, doctor’s office, pharmacy, at the bedside) or self-testing ( for example, used by individuals at home). Typically, these rapid test devices are simple to use and provide visual or simple results within a short time.
COVID-19 is an illness caused by a coronavirus. Coronaviruses are a large family of viruses, some of which infect animals and others that can infect humans.
This report presents evidence-informed recommendations for testing a vaccinated population and vaccinated individuals.
Diagnosing and how we test, testing importance and contact tracing, increasing testing supply, test accuracy, testing for travellers, national overview of tests performed, roles and responsibilities, authorized testing devices, testing devices under review, access to and types of testing devices, testing and screening expert advisory panel, indutry advisory roundtable, and rapid tests for workplace screening.
This guidance document presents the criteria for safety and effectiveness that apply to test swabs used for COVID-19 sampling. It also provides guidance on how to meet these criteria in an application under the IO pathway.
This guidance document presents the criteria for safety and effectiveness that apply to test swabs used for COVID-19 sampling. It also provides guidance on how to meet these criteria in an application under the IO pathway.