ARCHIVED Authorized medical devices for uses related to COVID-19: List of authorized testing devices

Notice to Reader:

This is an archived page. Please refer to the current version of the List of authorized medical devices under Part 1.1 of the MDR.

The list of authorized testing devices has been updated to include the available instructions for use for COVID-19 tests. Please refer to this section for more information before searching for the COVID-19 test you are looking for.

Number of authorized testing devices

Device type	Number authorized
Authorized testing devices intended for point-of-care use (often referred to as rapid tests)	33
Self-testing devices	26
Antigen Testing Devices	48
Nucleic Acid Testing Devices (often referred to as PCR)	37
Serological Testing Devices	12
Total number of authorized COVID-19 testing devices	97

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* Point-of-care testing devices (rapid tests) and self-testing devices totals include antigen, nucleic acid (PCR) and serological testing devices.

On this page

• Authorization of COVID-19 testing devices
• Medical device incidents
• Understanding the "testing information" column
• Authorized instructions for use
• Authorized testing devices list

Authorization of COVID-19 testing devices

Health Canada has authorized a variety of COVID-19 tests based on data supporting their intended use.

Each test is authorized for:

• specific age groups (adults or children)
• the way samples should be collected (nasal or saliva)
• who should be collecting them (health professional or individual)
• where the test is done (lab, point-of-care or at home)

Using testing devices as directed

Always follow the instructions contained in your test kit or provided by your local health authority. The instructions tell you how to collect a sample and take the test. They are written specifically for that type of kit. If you take a sample in a different way, your test result may be inaccurate.

Health Canada works closely with manufacturers and public health partners to ensure the most up-to-date information is made available.

The Canadian Agency for Drugs and Technologies in Health (CADTH) conducted an environmental scan related to sample collection for testing during the Omicron variant. They looked at scientific literature as well as recommendations in Canadian and international jurisdictions. We reviewed these findings and continue to recommend that COVID-19 testing devices be used according to the instructions contained in the test kit.

Review the full CADTH report titled Self-collection of nose and throat swab samples for SARS-CoV-2 antigen testing.

Medical device incidents

If you have witnessed or experienced a problem with a medical device, including a COVID-19 test, you should report it. You should report the problem directly to the manufacturer of the test. Look for contact details for the manufacturer on the box and/or the test's instructions for use.

You may also report your concern directly to Health Canada.

Understanding the "testing information" column

For each device, the following table identifies the authorized technology type, intended setting(s), sample type(s), intended population(s), shelf life and sensitivity.

Technology types

• nucleic acid testing devices
• antigen testing devices
• serological testing devices

Intended setting

Devices may be authorized for more than 1 type of setting. For example:

• Lab-based tests are conducted in a lab environment by a trained laboratory technician.
• Point-of-care (POC) testing devices are used by an approved operator (often a health care professional) in a near-patient environment like a medical office or at the bedside.
• Self-testing devices are those that can be purchased and used by the public.

Refer to the point-of-care or self-testing webpage for more information.

Sample type

Devices may be authorized for multiple sample types and can include the following:

• nasopharyngeal (NP)
• oropharyngeal (OP)
• bronchoalveolar lavage (BAL)
• nasal
• self-collected swabs under the supervision of a health care professional

For specific sample collection methods, look for the instructions for use provided for each specific device.

Intended population

Devices have been authorized for use by different types of patients. The following table indicates all authorized patient types, along with any differences in the sensitivity values associated with the intended population:

• Symptomatic: people who have the signs and symptoms of COVID-19 or are suspected of having COVID-19 by a health care provider
• Asymptomatic: people who do not have any signs or symptoms of COVID-19
• Asymptomatic (serial testing): indicates tests that require 2 or more tests within a given time frame for people who are asymptomatic
  • for more information on serial asymptomatic testing, visit COVID-19 rapid antigen testing devices that use serial testing for individuals without symptoms: Notice to industry

Shelf life

The following table indicates the most recently authorized shelf life of a device. Extensions for shelf life may be granted:

• by the manufacturer seeking an extension through an amendment or
• through an expanded use authorization

For more information on tests that may have an expanded use indication, please visit:

• List of medical devices for expanded use in relation to COVID-19

Health Canada continues to work closely with our federal, provincial and territorial partners, and the manufacturing community, to support additional shelf life extensions.

Sensitivity

Sensitivity values are presented to provide transparency around clinical performance data that were filed with Health Canada at the time of submission. Sensitivity is a measure of the accuracy of a test against a reference standard. Only the most conservative values pertaining to SARS-CoV-2 are presented where either:

• multiple clinical datasets have been provided to us for evaluation
• the test is designed to identify more than just SARS-CoV-2
• multiple datasets have been provided for different sample types

Tests that identify antibodies (serological tests) do not have their sensitivity value posted in the table. The sensitivity value for these tests depends on many factors. For more information, please consult the instructions for use provided with your test. For serological tests within the testing information column, the target epitope will be identified instead of sensitivity.

Tests that identify antibodies to the spike protein of the SARS-CoV-2 virus, however, will be unable to distinguish between people who have been infected and who have been vaccinated.

Variants

Variants of a virus are versions of the virus in which the nucleic acids are different. Variants can impact the performance of a test. A false negative result can occur with any test. However, the test is more likely to give a false negative result if what it detects is changed as a result of the differences in the variant.

The impact of variants on each test will depend on:

• what has changed, whether only the nucleic acids or also the antigens and antibodies
• what the test detects, whether nucleic acids, antigens or your antibodies
• if the test detects more than 1 part of the virus
  • since variants are expected, some tests are designed to detect more than 1 part of the virus

A negative test result should be considered along with a person's symptoms, history of exposure to the virus and the variant of virus that is common in their area.

Given that virus variants are common and expected, Health Canada continues to review available information. We are working with other regulators and manufacturers of COVID-19 test devices to monitor any impact that variants may have on the ability of diagnostic tests approved by Health Canada to detect COVID-19 variants. If an issue is identified, we will work quickly with manufacturers and public health laboratories to mitigate those risks.

Additional attributes

The table also indicates if the following apply to any of the authorized devices:

Visual read versus instrument read

Results of the COVID-19 test can be displayed:

• using an instrument or
• visually on the device itself using coloured bands or other visual indications

The testing information column indicates if the test can be read on an instrument or visually as follows:

• Instrument read: an instrument such as an analyzer, PCR machine or mobile app can be used to read the results
• Visual read: the result can be read directly from the single-use product such as a testing cassette

Multiplex

Some COVID-19 testing devices allow for other respiratory viruses (for example, influenza A and B and RSV) to be detected at the same time. These tests are indicated by the term multiplex.

Self-collection

Some COVID-19 testing devices may be used by a person to collect their own nasal or saliva samples under the supervision of a health care provider. These testing devices only apply to point-of-care and lab-based tests, as self-tests do not require supervision by a health care provider.

Sample pooling

Some COVID-19 testing devices make it possible to pool samples together for testing, but this strategy will differ from test to test. For more information, please consult the "instructions for use" on how sample pooling may be used with the relevant testing device.

Expanded use

Part 1.1 of the Medical Devices Regulations permits the authorization of new COVID-19 uses for devices already approved in Canada when scientific data supports this. COVID-19 testing devices that have received an expanded use authorization will show the symbol EU. The List of Medical Devices for Expanded Use in Relation to COVID-19 provides additional information on the expansion of use for specific COVID-19 testing devices.

Authorized instructions for use

To help consumers use COVID-19 testing devices safely and effectively, we have published available authorized instructions for use (IFU) for authorized devices.

To access the relevant IFU for that device, please click on the hyperlink in the "device identifier" column in the following table.

Please note that not all device identifiers will have an IFU.

• A device identifier is like a catalogue number for medical devices. It can represent a part or combination of parts. The manufacturer defines what each unique device identifier represents for their device. Device identifiers are assigned to entire test kits, such as a pack of tests, or a test kit component, such as a swab. Since not all parts of a medical device require an IFU, some device identifiers will not have one.

Some devices will have multiple versions of IFUs for a single device to account for different configurations of their test kit. For example, an authorization can have a nasal version and a nasopharyngeal version, each with its own device identifier and IFU.

Manufacturers of self-testing devices must provide IFUs in both official languages as part of the authorization review process. However, manufacturers of testing devices intended for use only in a point-of-care or lab setting do not have to submit their IFUs in both official languages.

The manufacturer is responsible for providing accurate translation of the approved IFU into the second official language.

Please note that for recently authorized devices, there may be a delay in posting the IFU in both official languages due to translations and finalization of the labelling.

If an IFU is available in only 1 official language, contact the manufacturer to request it in the other official language.

Authorized testing devices list

The entries in this list represent each individual device identifier included on each authorization. In other words, a single authorization may be for multiple devices, such as a testing device and control kits, that are meant to be used together to conduct the test.

Within the authorization, each device is listed separately. The "Authorization date" column indicates the first date that the testing device was authorized for sale. Manufacturers may amend their authorizations to add additional devices over time. The date that new device identifiers are added is reflected in the "device first issued" column.