Health Canada reviews and authorizes the use of COVID-19 medical devices on behalf of the federal government. This includes COVID-19 testing devices, such as rapid antigen tests (rapid tests), polymerase chain reaction (PCR) tests, and serological testing devices.

Canada classifies medical devices into four classes, based on the risk their intended use.

  • Class I: masks, respirators, gowns, face shields
  • Class II: infrared thermometers, gloves, personal protective equipment (PPE) decontamination devices, syringes
  • Class III: ventilators
  • Class IV: SARS-CoV-2 testing devices

During the COVID-19 pandemic, Health Canada is receiving a very high volume of device authorization requests. Manufacturers interested in having their diagnostic testing devices authorized should visit the Government of Canada website for more information. The federal government’s goal is to increase the number of devices authorized for use in detecting active COVID-19 cases.

COVID-19 Rapid Tests Authorized by Health Canada

The following table shows the COVID-19 testing device applications authorized by Health Canada as of May 30, 2021.

Authorization Date Manufacturer Device Name Testing Information
Ortho-Clinical Diagnostics (Great Britain)
Vitros Immunodiagnostic Products SARS-CoV-2 Antigen
Antigen Technology

Lab-based Test

Sensitivity = 95.7%
Pcl Inc. (South Korea)
Pcl COVID19 AG Rapid Fia
Antigen Technology

Lab-based Test

Sensitivity = 94.29%
Assure Tech. (Hangzhou) Co. Ltd. (China)
COVID-19 Antigen Rapid Test Device
Antigen Technology

Lab-based And Point Of Care

Test Sensitivity = 94.3%
Btnx Inc. (Canada)
Antigen Technology

Lab-based And Point Of Care

Test Sensitivity = 90.2%
Sd Biosensor, Inc. (South Korea)
Antigen Technology

Lab-based And Point Of Care

Test Sensitivity = 86.2%
Abbott Rapid Diagnostics Jena Gmbh (Germany)
Antigen Technology

Lab-based And Point Of Care

Test Sensitivity = 91.1%
Quidel Corporation (United States)
Antigen Technology

Lab-based And Point Of Care

Test Sensitivity = 96.7%
Becton Dickinson and Company (BD) (United States)
Antigen Technology

Lab-based And Point Of Care

Test Sensitivity = 83.9%
Abbott Rapid Diagnostics Jena Gmbh (Germany)
Antigen Technology

Lab-based And Point Of Care

Test Sensitivity = 91.4%

Benefits of Rapid Tests

Rapid tests are viewed as a critical tool to help stop the spread of COVID-19 in Canada. The primary benefits of rapid tests include:

  • the ability for non-professionals to do the test
  • lower cost compared to PCR tests
  • faster turnaround times

These beneficial characteristics of rapid testing mean the rapid tests can become more widely used as a screening tool for COVID-19. This will be particularly important in Canada, where COVID-19 vaccines need to be imported and have experienced distribution delays.

Rapid Test & Trace Canada co-wrote an open letter with the Canadian Chamber of Commerce calling for Canada to urgently implement widespread rapid testing for COVID-19.

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Read our open letter arguing for the adoption of widespread rapid testing in Canada was signed by 28 members of the medical and business communities.

How to Test for COVID-19?

There are two test types to detect COVID-19 that are authorized for use in Canada.

  1. Molecular tests – also known as nucleic acid-based testing and commonly referred to as PCR tests
  2. Antigen tests – commonly referred to as rapid tests

The key differences between these tests are processing time and test sensitivity and specificity.

What is a PCR Test?

PCR is the acronym for polymerase chain reaction. PCR testing is nucleic acid-based testing, which is also called molecular testing. Molecular tests detect the virus genetic material (nucleic acids).

This type of test is considered the global gold standard to diagnose active COVID-19 infection in symptomatic patients. In Canada, PCR tests are used by public health laboratories to diagnose COVID-19 infection.

Health Canada has authorized a number of diagnostic tests using nucleic acid technology. These tests are listed on the Health Canada website and are authorized for use in the lab and at point-of-care.

A test swab may be used to collect a sample for PCR testing in laboratories or at a point-of-care facility. Point-of-care testing can be done directly in a hospital or doctor’s office. The deep test swabs are used to collect samples from the oral or nasal cavities.

Once the sample has been taken, the swab is either placed:

  • in a preserving liquid and sent to a laboratory for testing or
  • placed directly in a testing device (point-of-care)

Depending on where you live in Canada, PCR testing for COVID-19 may not currently be available to asymptomatic people. Many jurisdictions have had to restrict testing to symptomatic people in order to reduce the demands on the provincial health care systems.

What is Rapid Testing for COVID-19?

Rapid tests, also known as antigen tests, detect proteins on the surface of the virus. They can also be used to detect proteins from inside of the virus that are released after breaking up the virus using a simple soap solution.

These antigen tests are commonly known as rapid tests because they typically provide results in under 30 minutes. While lab-based antigen testing for COVID-19 also exists, rapid tests can be administered by a trained operator at point-of-care facilities or designated testing sites. Rapid tests typically require a deep nasal swab, although studies from the medical community are showing very good results with simple nasal swabs.

Canada’s COVID-19 Testing and Screening Expert Advisory Panel released its fifth report on August 12, 2021, providing recommendations on the use of self-tests within Canada.

This video from our co-founder Sandy White, shows you the different types of test that we carry.

This next video featuring our co-founder Sandy White, shows you a step-by-step demonstration of how to self-administer a rapid test.

Are Rapid Tests Accurate?

Depending on the test model, sample collection method, and stage of patient infectiousness, rapid tests can be less sensitive than PCR tests. This has led to a common misconception that rapid tests should be not be used as part of Canada’s strategy to stop the spread of the coronavirus. There are literally millions of rapid tests sitting in warehouses across Canada.

A less sensitive test may lead to false negatives or false-positive results. The sensitivity rate of the rapid antigen tests authorized by Health Canada ranges from 86.2% to 96.7%.

False Negatives

The worry from public health officials is that when a rapid test produces a false negative result, it can give the patient a false sense of security.

False Positives

False positives from rapid tests are becoming less common. The newer rapid test models show lower false-positive rates than PCR tests.

However, if a person does test positives with a rapid test, the recommendation is to first take a second rapid test to confirm the positive result. Preferably, the confirmatory test would use a different model of antigen test.

If the confirmatory test result is also positive, the patient should immediately go for a PCR test and isolate until the test result is known.

How Long Does it Take to Get COVID-19 Test Results?

How long it takes to get your COVID-19 test results depends on the type of test that was administered. A PCR can be processed by a laboratory in 12-24 hours. However, in most jurisdictions throughout Canada, it can take 1-5 days to receive a PCR test result.

A rapid antigen test can return a result in about 15-30 minutes, depending on the test model.

What are the Symptoms of COVID-19

Symptoms of COVID-19 can vary from person to person and also in different age groups. Following are the commonly reported symptoms identified by Health Canada:

  • new or worsening cough
  • shortness of breath or difficulty breathing
  • temperature equal to or over 38°C
  • feeling feverish
  • chills
  • fatigue or weakness
  • muscle or body aches
  • new loss of smell or taste
  • headache
  • gastrointestinal symptoms (abdominal pain, diarrhea, vomiting)
  • feeling very unwell

Should I Get Tested for COVID?

Symptoms of COVID-19 may take up to 14 days to appear after exposure. It’s important to know that you can infect others even if you aren’t showing symptoms of COVID-19.

The virus can be spread to others from someone who’s infected but not showing symptoms. This includes people who:

  • haven’t yet developed symptoms (pre-symptomatic)
  • never develop symptoms (asymptomatic)

This is why widespread rapid testing and tracing is critical to stopping the spread of COVID-19. The more people Canada tests, the more quickly we will be able to identify and isolate infectious individuals.

How to Get Rapid Tests for Your WorkPlace

If your company or organization is interested in rapid testing solutions, contact us today to learn how rapid testing and tracing can help protect your workplace from the risks of COVID-19.

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