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 associated with 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 July 5, 2022.
2022
| Authorization Date | Manufacturer | Device Name | Testing Information |
|---|---|---|---|
|
2022-10-26 |
Response Biomedical Corporation (Canada) |
Ramp COVID-19 Antigen Test |
Antigen Technology lab-based Test nasal symptomatic instrument Read shelf-life = 24 Month sensitivity = 84% |
|
2022-10-12 |
Lumiradx Uk Ltd. (Great Britain) |
Lumiradx SARS-CoV-2 AG |
Antigen Technology point Of Care Test nasal Np symptomatic, Instrument Read sensitivity = 97.6% (nasal) shelf-life = 10 Months |
|
2022-08-19 |
Medsup Medical (Canada) |
Medsup COVID-19 Antigen Rapid Test (self-testing) |
Antigen Technology Self-testing Nasal Symptomatic Asymptomatic (serial Testing) Visual Read Sensitivity: 94.12% (sensitivity Has Not Been Established For Asymptomatic Serial Testing). Shelf-life: 24 Months |
|
2022-08-09 |
Gene Biotechnology Enterprises Ltd Dba Gene Bio Medical (Canada) |
Swiftswab COVID-19 Antigen Self Test |
Antigen Technology self-testing pop: Serial Testing Symptomatic And Asymptomatic shelf Life: 18 Months sample: Nasal sensitivity: Symptomatic (82.7%); Serial And Asymptomatic Testing (clinical Sensitivity To Be Established) |
|
2022-08-04 |
Access Bio, Inc. (United States) |
Carestarttm COVID-19 Antigen Home Test |
Antigen Technology Self-testing Nasal Symptomatic, Asymptomatic (serial Testing) Visual Read Shelf Life: 12 Months Sensitivity: 86.67% (symptomatic) Sensitivity Has Not Been Established For Serial Testing |
|
2022-07-29 |
Acon Laboratories, Inc. (United States) |
Flowflex COVID-19 Antigen Rapid Test |
Antigen Technology Point Of Care Test Nasal, Symptomatic, Asymptomatic Visual Read Shelf Life: 24 Months Sensitivity: 93% (symptomatic, Asymptomatic) |
|
2022-07-22 |
Humasis Co., Ltd, (South Korea)
|
Humasis COVID-19 AG Home Test |
Antigen Technology Self-testing Mid-turbinate Nasal Symptomatic, Asymptomatic (serial Testing), Visual Read Sensitivity: 86.7% (symptomatic And Asymptomatic, Sensitivity Has Not Been Established For Serial Testing)) Shelf Life: 18 Months |
|
2022-07-19 |
Acon Laboratories, Inc. (United States) |
Flowflex COVID-19 Antigen Home Test |
Antigen Technology self-testing nasal symptomatic, Asymptomatic, Visual Read Sensitivity = 93% shelf-life = 24 Months |
|
2022-06-24 |
Princeton Biomeditech Corp (United States) |
Antigen Technology Lab-based And Point of Care Test Sensitivity = 93.1% |
|
|
2022-06-03 |
Acon Biotech (Hangzhou) Co., Ltd. (China) |
Antigen Technology Self Test Test Sensitivity = 94.12% |
|
|
2022-05-27 |
Xiamen Boson Biotech Co., Ltd. (China) |
Antigen Technology Self Test Test Sensitivity = 82.7% |
|
|
2022-05-19 |
Sd Biosensor, Inc. (South Korea) |
Antigen Technology Self Test Test Sensitivity = 87.8% |
|
|
2022-05-05 |
Pcl Inc. (South Korea) |
Antigen Technology Self Test Test Sensitivity = 90.14% |
|
|
2022-04-28 |
Andon Medical Co., Ltd. (China) |
Antigen Technology Self Test Test Sensitivity = 85-94.3% |
|
|
2022-04-08 |
Pcl Inc. (South Korea) |
Antigen Technology Point of Care Test Sensitivity = 88.5% |
|
|
2022-04-01 |
Biolytical Laboratories Inc. (Canada) |
Antigen Technology Self Test |
|
|
2022-04-01 |
Healgen Scientific Limited Liability Company (United States) |
Antigen Technology Self Test Test Sensitivity = 86.5% |
|
|
2022-03-29 |
Medsup Medical (Canada) |
Antigen Technology Lab-based and Point of Care Test Sensitivity = 97.1% |
|
|
2022-03-18 |
Abbott Diagnostics Scarborough, Inc. (United States) |
Antigen Technology Point of Care Test Sensitivity = 84.6% |
|
|
2022-03-04 |
Biolytical Laboratories Inc. (Canada) |
Antigen Technology Point of Care |
|
|
2022-3-04 |
Btnx Inc. (Canada) |
Antigen Technology Self Test Test Sensitivity = 94.51% |
|
|
2022-02-24 |
Becton Dickinson And Company (Bd) (United States) |
Antigen Technology Point of Care Test Sensitivity = 86.7% |
|
|
2022-02-11 |
Acon Biotech (Hangzhou) Co., Ltd. (China) |
Antigen Technology Lab-based And Point of Care |
|
|
2022-01-21 |
Sugentech, Inc. (South Korea) |
Antigen Technology Lab-based And Point of Care |
|
|
2022-01-20 |
Access Bio, Inc. (United States) |
Antigen Technology Lab-based And Point of Care Test Sensitivity = 87.18% |
|
|
2022-01-12 |
Abbott Diagnostics Scarborough, Inc. (United States) |
Antigen Technology Self Test Test Sensitivity = 91.7% |
| Authorization Date | Manufacturer | Device Name | Testing Information |
|---|---|---|---|
|
2022-10-26 |
Response Biomedical Corporation (Canada) |
Antigen Technology lab-based Test nasal symptomatic instrument Read shelf-life = 24 Month sensitivity = 84% |
|
|
2022-10-12 |
Lumiradx Uk Ltd. (Great Britain) |
Antigen Technology point Of Care Test nasal Np symptomatic, Instrument Read sensitivity = 97.6% (nasal) shelf-life = 10 Months |
|
|
2022-08-19 |
Medsup Medical (Canada) |
Antigen Technology Self-testing Nasal Symptomatic Asymptomatic (serial Testing) Visual Read Sensitivity: 94.12% (sensitivity Has Not Been Established For Asymptomatic Serial Testing). Shelf-life: 24 Months |
|
|
2022-08-09 |
Gene Biotechnology Enterprises Ltd Dba Gene Bio Medical (Canada) |
Antigen Technology self-testing pop: Serial Testing Symptomatic And Asymptomatic shelf Life: 18 Months sample: Nasal sensitivity: Symptomatic (82.7%); Serial And Asymptomatic Testing (clinical Sensitivity To Be Established) |
|
|
2022-08-04 |
Access Bio, Inc. (United States) |
Antigen Technology Self-testing Nasal Symptomatic, Asymptomatic (serial Testing) Visual Read Shelf Life: 12 Months Sensitivity: 86.67% (symptomatic) Sensitivity Has Not Been Established For Serial Testing |
|
|
2022-07-29 |
Acon Laboratories, Inc. (United States) |
Flowflex COVID-19 Antigen Rapid Test L031-13015 |
Antigen Technology Point Of Care Test Nasal, Symptomatic, Asymptomatic Visual Read Shelf Life: 24 Months Sensitivity: 93% (symptomatic, Asymptomatic) |
|
2022-07-22 |
Humasis Co., Ltd, (South Korea)
|
Antigen Technology Self-testing Mid-turbinate Nasal Symptomatic, Asymptomatic (serial Testing), Visual Read Sensitivity: 86.7% (symptomatic And Asymptomatic, Sensitivity Has Not Been Established For Serial Testing)) Shelf Life: 18 Months |
|
|
2022-07-19 |
Acon Laboratories, Inc. (United States) |
Antigen Technology self-testing nasal symptomatic, Asymptomatic, Visual Read Sensitivity = 93% shelf-life = 24 Months |
2021
| Authorization Date | Manufacturer | Device Name | Testing Information |
|---|---|---|---|
|
2021-12-23 |
Orasure Technologies, Inc. (United States) |
Antigen Technology Self Test Test Sensitivity = 85% |
|
|
2021-12-21 |
Abbott Rapid Diagnostics Jena Gmbh (Germany) |
Antigen Technology Self Test |
|
|
2021-12-15 |
Orasure Technologies, Inc. (United States) |
Antigen Technology Self Test Test Sensitivity = 85% |
|
|
2021-12-10 |
Sd Biosensor, Inc. (South Korea) |
Antigen Technology Self Test Test Sensitivity = 94.94% |
|
|
2021-11-26 |
Empowered Diagnostics, Llc (United States) |
Antigen Technology Self Test Test Sensitivity = 96% |
|
|
2021-11-02 |
Diasorin Inc. (United States) |
Antigen Technology Lab-based Test Sensitivity = 96.1% |
|
|
2021-10-20 |
Artron Laboratories Inc. (Canada) |
Antigen Technology Lab-based Test and Point of Care Test Sensitivity =97.22% |
|
|
2021-10-19 |
Becton Dickinson And Company (Bd) (United States) |
Antigen Technology Lab-based Test and Point of Care Test Sensitivity = 84% |
|
|
2021-09-24 |
Princeton Biomeditech Corp (United States) |
Antigen Technology Point of Care Test Sensitivity = 93.1% |
|
|
2021-09-21 |
Ellume Limited (Australia) |
Antigen Technology Self Test Test Sensitivity = 95% |
|
|
2021-09-17 |
Quidel Corporation (United States) |
Antigen Technology Lab-based Test and Point of Care Test Sensitivity = 96.6% |
|
|
2021-08-26 |
Quidel Corporation (United States) |
Antigen Technology Self Test Test Sensitivity = 81.3% |
|
|
2021-08-05 |
Xiamen Boson Biotech Co., Ltd. (China) |
Antigen Technology Lab-based Test Test Sensitivity = 93.75% |
|
|
2021-07-23 |
Quidel Corporation (United States) |
Antigen Technology Point of Care Test Sensitivity = 95.2% |
|
|
2021-06-21 |
Sd Biosensor, Inc. (South Korea) |
Antigen Technology Lab-based and Point of Care Test Sensitivity = 86.7% |
|
|
2021-05-10 |
Ortho-Clinical Diagnostics (Great Britain) |
Antigen Technology Lab-based Test Sensitivity = 95.7% |
|
|
2021-03-19 |
Pcl Inc. (South Korea) |
Antigen Technology Lab-based Test Sensitivity = 94.29% |
|
|
2021-02-19 |
Assure Tech. (Hangzhou) Co. Ltd. (China) |
Antigen Technology Lab-based And Point Of Care Test Sensitivity = 94.3% |
|
|
2021-02-19 |
Btnx Inc. (Canada) |
Antigen Technology Lab-based And Point Of Care Test Sensitivity = 90.2% |
|
|
2021-02-10 |
Sd Biosensor, Inc. (South Korea) |
Antigen Technology Lab-based And Point Of Care Test Sensitivity = 86.2% |
| Authorization Date | Manufacturer | Device Name | Testing Information |
|---|---|---|---|
|
2021-12-15 |
Orasure Technologies, Inc. (United States) |
Antigen Technology Self Test Test Sensitivity = 85% |
|
|
2021-12-21 |
Abbott Rapid Diagnostics Jena Gmbh (Germany) |
Antigen Technology Self Test |
|
|
2021-12-23 |
Orasure Technologies, Inc. (United States) |
Antigen Technology Self Test Test Sensitivity = 85% |
|
|
2022-1-12 |
Abbott Diagnostics Scarborough, Inc. (United States) |
Antigen Technology Self Test Test Sensitivity = 91.7% |
|
|
2022-1-20 |
Access Bio, Inc. (United States) |
Antigen Technology Lab-based And Point of Care Test Sensitivity = 87.18% |
|
|
2022-1-21 |
Sugentech, Inc. (South Korea) |
Antigen Technology Lab-based And Point of Care |
|
|
2022-2-11 |
Acon Biotech (Hangzhou) Co., Ltd. (China) |
Antigen Technology Lab-based And Point of Care |
|
|
2022-2-24 |
Becton Dickinson And Company (Bd) (United States) |
Antigen Technology Point of Care Test Sensitivity = 86.7% |
|
|
2022-3-04 |
Btnx Inc. (Canada) |
Antigen Technology Self Test Test Sensitivity = 94.51% |
|
|
2022-3-04 |
Biolytical Laboratories Inc. (Canada) |
Antigen Technology Point of Care |
|
|
2022-3-18 |
Abbott Diagnostics Scarborough, Inc. (United States) |
Antigen Technology Point of Care Test Sensitivity = 84.6% |
|
|
2022-3-29 |
Medsup Medical (Canada) |
Antigen Technology Lab-based and Point of Care Test Sensitivity = 97.1% |
|
|
2022-4-01 |
Healgen Scientific Limited Liability Company (United States) |
Antigen Technology Self Test Test Sensitivity = 86.5% |
|
|
2022-4-01 |
Biolytical Laboratories Inc. (Canada) |
Antigen Technology Self Test |
|
|
2022-04-08 |
Pcl Inc. (South Korea) |
Antigen Technology Point of Care Test Sensitivity = 88.5% |
|
|
2022-04-28 |
Andon Medical Co., Ltd. (China) |
Antigen Technology Self Test Test Sensitivity = 85-94.3% |
|
|
2022-05-05 |
Pcl Inc. (South Korea) |
Antigen Technology Self Test Test Sensitivity = 90.14% |
|
|
2022-05-19 |
Sd Biosensor, Inc. (South Korea) |
Antigen Technology Self Test Test Sensitivity = 87.8% |
|
|
2022-05-27 |
Xiamen Boson Biotech Co., Ltd. (China) |
Antigen Technology Self Test Test Sensitivity = 82.7% |
|
|
2022-06-03 |
Acon Biotech (Hangzhou) Co., Ltd. (China) |
Antigen Technology Self Test Test Sensitivity = 94.12% |
|
|
2022-06-24 |
Princeton Biomeditech Corp (United States) |
Antigen Technology Lab-based And Point of Care Test Sensitivity = 93.1% |
2020
| Authorization Date | Manufacturer | Device Name | Testing Information |
|---|---|---|---|
|
2020-10-05 |
Abbott Rapid Diagnostics Jena Gmbh (Germany) |
Antigen Technology Lab-based And Point Of Care Test Sensitivity = 91.4% |
|
|
2020-10-09 |
Becton Dickinson and Company (BD) (United States) |
Antigen Technology Lab-based And Point Of Care Test Sensitivity = 83.9% |
|
|
2020-10-26 |
Quidel Corporation (United States) |
Antigen Technology Lab-based And Point Of Care Test Sensitivity = 96.7% |
|
|
2020-12-31 |
Abbott Rapid Diagnostics Jena Gmbh (Germany) |
Antigen Technology Lab-based And Point Of Care Test Sensitivity = 91.1% |
| Authorization Date | Manufacturer | Device Name | Testing Information |
|---|---|---|---|
|
2020-10-05 |
Abbott Rapid Diagnostics Jena Gmbh (Germany) |
Antigen Technology Lab-based And Point Of Care Test Sensitivity = 91.4% |
|
|
2020-10-09
|
Becton Dickinson and Company (BD) (United States)
|
Antigen Technology Lab-based And Point Of Care Test Sensitivity = 83.9% |
|
|
2020-10-26
|
Quidel Corporation (United States)
|
Antigen Technology Lab-based And Point Of Care Test Sensitivity = 96.7% |
|
|
2020-12-31
|
Abbott Rapid Diagnostics Jena Gmbh (Germany)
|
Antigen Technology Lab-based And Point Of Care Test Sensitivity = 91.1% |
|
|
2021-02-10
|
Sd Biosensor, Inc. (South Korea)
|
Antigen Technology Lab-based And Point Of Care Test Sensitivity = 86.2% |
|
|
2021-02-19
|
Btnx Inc. (Canada)
|
Antigen Technology Lab-based And Point Of Care Test Sensitivity = 90.2% |
|
|
2021-02-19 |
Assure Tech. (Hangzhou) Co. Ltd. (China)
|
Antigen Technology Lab-based And Point Of Care Test Sensitivity = 94.3% |
|
|
2021-03-19
|
Pcl Inc. (South Korea)
|
Antigen Technology Lab-based Test Sensitivity = 94.29% |
|
|
2021-05-10
|
Ortho-Clinical Diagnostics (Great Britain)
|
Antigen Technology Lab-based Test Sensitivity = 95.7% |
|
|
2021-06-21 |
Sd Biosensor, Inc. (South Korea) |
Antigen Technology Lab-based and Point of Care Test Sensitivity = 86.7% |
|
|
2021-07-23 |
Quidel Corporation (United States) |
Antigen Technology Point of Care Test Sensitivity = 95.2% |
|
|
2021-08-05 |
Xiamen Boson Biotech Co., Ltd. (China) |
Antigen Technology Lab-based Test Test Sensitivity = 93.75% |
|
|
2021-08-26 |
Quidel Corporation (United States) |
Antigen Technology Self Test Test Sensitivity = 81.3% |
|
|
2021-09-17 |
Quidel Corporation (United States) |
Antigen Technology Lab-based Test and Point of Care Test Sensitivity = 96.6% |
|
|
2021-09-21 |
Ellume Limited (Australia) |
Antigen Technology Self Test Test Sensitivity = 95% |
|
|
2021-09-24 |
Princeton Biomeditech Corp (United States) |
Antigen Technology Point of Care Test Sensitivity = 93.1% |
|
|
2021-10-05 |
Becton Dickinson And Company (Bd) (United States) |
Antigen Technology Lab-based Test and Point of Care Test Sensitivity = 84% |
|
|
2021-10-19 |
Becton Dickinson And Company (Bd) (United States) |
Antigen Technology Self Test Test Sensitivity = 84.6% |
|
|
2021-10-20 |
Artron Laboratories Inc. (Canada) |
Antigen Technology Lab-based Test and Point of Care Test Sensitivity =97.22% |
|
|
2021-11-02 |
Diasorin Inc. (United States) |
Antigen Technology Lab-based Test Sensitivity = 96.1% |
|
|
2021-11-02 |
Lumos Diagnostics Ata Rapid Pathogen Screening Inc Ata Lumos Diagnostics Inc (United States) |
Antigen Technology Point of Care Test Sensitivity = 85.1% |
|
|
2021-11-26 |
Empowered Diagnostics, Llc (United States) |
Antigen Technology Self Test Test Sensitivity = 96% |
|
| Authorization Date | Manufacturer | Device Name | Testing Information |
|---|---|---|---|
|
2020-10-05 |
Abbott Rapid Diagnostics Jena Gmbh (Germany) |
Antigen Technology Lab-based And Point Of Care Test Sensitivity = 91.4% |
|
|
2020-10-09
|
Becton Dickinson and Company (BD) (United States)
|
Antigen Technology Lab-based And Point Of Care Test Sensitivity = 83.9% |
|
|
2020-10-26
|
Quidel Corporation (United States)
|
Antigen Technology Lab-based And Point Of Care Test Sensitivity = 96.7% |
|
|
2020-12-31
|
Abbott Rapid Diagnostics Jena Gmbh (Germany)
|
Antigen Technology Lab-based And Point Of Care Test Sensitivity = 91.1% |
|
|
2021-02-10
|
Sd Biosensor, Inc. (South Korea)
|
Antigen Technology Lab-based And Point Of Care Test Sensitivity = 86.2% |
|
|
2021-02-19
|
Btnx Inc. (Canada)
|
Antigen Technology Lab-based And Point Of Care Test Sensitivity = 90.2% |
|
|
2021-02-19 |
Assure Tech. (Hangzhou) Co. Ltd. (China)
|
Antigen Technology Lab-based And Point Of Care Test Sensitivity = 94.3% |
|
|
2021-03-19
|
Pcl Inc. (South Korea)
|
Antigen Technology Lab-based Test Sensitivity = 94.29% |
|
|
2021-05-10
|
Ortho-Clinical Diagnostics (Great Britain)
|
Antigen Technology Lab-based Test Sensitivity = 95.7% |
|
|
2021-06-21 |
Sd Biosensor, Inc. (South Korea) |
Antigen Technology Lab-based and Point of Care Test Sensitivity = 86.7% |
|
|
2021-07-23 |
Quidel Corporation (United States) |
Antigen Technology Point of Care Test Sensitivity = 95.2% |
|
|
2021-08-05 |
Xiamen Boson Biotech Co., Ltd. (China) |
Antigen Technology Lab-based Test Test Sensitivity = 93.75% |
|
|
2021-08-26 |
Quidel Corporation (United States) |
Antigen Technology Self Test Test Sensitivity = 81.3% |
|
|
2021-09-17 |
Quidel Corporation (United States) |
Antigen Technology Lab-based Test and Point of Care Test Sensitivity = 96.6% |
|
|
2021-09-21 |
Ellume Limited (Australia) |
Antigen Technology Self Test Test Sensitivity = 95% |
|
|
2021-09-24 |
Princeton Biomeditech Corp (United States) |
Antigen Technology Point of Care Test Sensitivity = 93.1% |
|
|
2021-10-05 |
Becton Dickinson And Company (Bd) (United States) |
Antigen Technology Lab-based Test and Point of Care Test Sensitivity = 84% |
|
|
2021-10-19 |
Becton Dickinson And Company (Bd) (United States) |
Antigen Technology Self Test Test Sensitivity = 84.6% |
|
|
2021-10-20 |
Artron Laboratories Inc. (Canada) |
Antigen Technology Lab-based Test and Point of Care Test Sensitivity =97.22% |
|
|
2021-11-02 |
Diasorin Inc. (United States) |
Antigen Technology Lab-based Test Sensitivity = 96.1% |
|
|
2021-11-02 |
Lumos Diagnostics Ata Rapid Pathogen Screening Inc Ata Lumos Diagnostics Inc (United States) |
Antigen Technology Point of Care Test Sensitivity = 85.1% |
|
|
2021-11-26 |
Empowered Diagnostics, Llc (United States) |
Antigen Technology Self Test Test Sensitivity = 96% |
|
|
2021-12-10 |
Sd Biosensor, Inc. (South Korea) |
Antigen Technology Self Test Test Sensitivity = 94.94% |
|
|
2021-12-15 |
Orasure Technologies, Inc. (United States) |
Antigen Technology Self Test Test Sensitivity = 85% |
|
|
2021-12-21 |
Abbott Rapid Diagnostics Jena Gmbh (Germany) |
Antigen Technology Self Test |
|
|
2021-12-23 |
Orasure Technologies, Inc. (United States) |
Antigen Technology Self Test Test Sensitivity = 85% |
|
|
2022-1-12 |
Abbott Diagnostics Scarborough, Inc. (United States) |
Antigen Technology Self Test Test Sensitivity = 91.7% |
|
|
2022-1-20 |
Access Bio, Inc. (United States) |
Antigen Technology Lab-based And Point of Care Test Sensitivity = 87.18% |
|
|
2022-1-21 |
Sugentech, Inc. (South Korea) |
Antigen Technology Lab-based And Point of Care |
|
|
2022-2-11 |
Acon Biotech (Hangzhou) Co., Ltd. (China) |
Antigen Technology Lab-based And Point of Care |
|
|
2022-2-24 |
Becton Dickinson And Company (Bd) (United States) |
Antigen Technology Point of Care Test Sensitivity = 86.7% |
|
|
2022-3-04 |
Btnx Inc. (Canada) |
Antigen Technology Self Test Test Sensitivity = 94.51% |
|
|
2022-3-04 |
Biolytical Laboratories Inc. (Canada) |
Antigen Technology Point of Care |
|
|
2022-3-18 |
Abbott Diagnostics Scarborough, Inc. (United States) |
Antigen Technology Point of Care Test Sensitivity = 84.6% |
|
|
2022-3-29 |
Medsup Medical (Canada) |
Antigen Technology Lab-based and Point of Care Test Sensitivity = 97.1% |
|
|
2022-4-01 |
Healgen Scientific Limited Liability Company (United States) |
Antigen Technology Self Test Test Sensitivity = 86.5% |
|
|
2022-4-01 |
Biolytical Laboratories Inc. (Canada) |
Antigen Technology Self Test |
|
|
2022-04-08 |
Pcl Inc. (South Korea) |
Antigen Technology Point of Care Test Sensitivity = 88.5% |
|
|
2022-04-28 |
Andon Medical Co., Ltd. (China) |
Antigen Technology Self Test Test Sensitivity = 85-94.3% |
|
|
2022-05-05 |
Pcl Inc. (South Korea) |
Antigen Technology Self Test Test Sensitivity = 90.14% |
|
|
2022-05-19 |
Sd Biosensor, Inc. (South Korea) |
Antigen Technology Self Test Test Sensitivity = 87.8% |
|
|
2022-05-27 |
Xiamen Boson Biotech Co., Ltd. (China) |
Antigen Technology Self Test Test Sensitivity = 82.7% |
|
|
2022-06-03 |
Acon Biotech (Hangzhou) Co., Ltd. (China) |
Antigen Technology Self Test Test Sensitivity = 94.12% |
|
|
2022-06-24 |
Princeton Biomeditech Corp (United States) |
Antigen Technology Lab-based And Point of Care Test Sensitivity = 93.1% |
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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.
How to Test for COVID-19?
There are two test types to detect COVID-19 that are authorized for use in Canada.
- Molecular tests – also known as nucleic acid-based testing and commonly referred to as PCR tests
- 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 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.
Single Tweet FAQ on Rapid Tests
— Michael Mina (@michaelmina_lab) February 15, 2021
Q: Are there a lot of False Positives?
A: No. Newer rapid tests like Innova and Abbott show lower FP rates than PCR. A recent UK trial of Innova Test, and our Trial each found ZERO false positives out of >12,000 tests combined.
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.
