Yes! The Canadian Shield holds a Medical Device Establishment License from Health Canada.

The Rapid Response COVID-19 Antigen Rapid Test Device, manufactured by BTNX Inc., is a Health Canada authorized COVID-19 testing device for Point of Care testing. The Rapid Response COVID-19 Antigen Rapid Test Device is intended for use by trained laboratory personnel or health care professionals.

For a full list of authorized testing devices, please visit the Health Canada website.

Yes, there is tax charged on rapid tests! While there is a zero-rated tax exemption on PPE products (such as face shields and face masks), there is currently no zero-rated tax exemption for rapid testing devices in Canada.

Rapid Tests are used as a serial screening tool whereby individuals test themselves 2 or 3 times a week to detect if they are an asymptomatic carrier of covid-19. These tests are most effective when you are infectious and are one more layer of peace of mind and safety. 

Rapid antigen testing devices should only be used for screening purposes. Nucleic acid-based testing, also called molecular testing or PCR, is the gold standard to diagnose active COVID-19 infection in patients with symptoms. For more information about self-testing and antigen testing devices, please visit the Health Canada website here. 

If the appropriate test procedure and result interpretation has been followed and the result of your rapid antigen test is positive – contact your healthcare providers. You will need to have a second swab taken within 48 hours with a regular laboratory-based PCR test or a rapid molecular test. This may occur at a designated testing site. The result from this test would confirm if you truly tested positive for COVID-19. Continue to self-isolate while waiting for the laboratory PCR test result.

The BTNX Rapid Response Rapid Test cannot be used for travel. The regulations around COVID testing for travel is highly dependent on the country you are traveling to. While rapid antigen tests may be accepted in some countries, these tests need to be performed and signed-off by a trained individual, doctor, or pharmacist. We highly recommend you inquire with your country of destination or airline to find out what type of test you need to travel.  

Compared to the regular laboratory-based PCR test, COVID-19 rapid antigen tests must be considered preliminary. The results from the antigen test must be confirmed with a regular laboratory-based PCR test. Interpretation of results in different populations varies based on specimen type collected and pre-test probability of COVID-19 in the patient being tested.

If we adjust the timeline for pre-orders online, this is for all *new* pre-orders going forward.

The Canadian Shield team is actively working to fulfill pre-orders within the stated timeline when you placed your order. If anything should change, our team will be in touch.

Currently, there are national supply chain shortages for rapid tests that have caused some delays. We appreciate your patience and we look forward to getting rapid tests into the hands of Canadians across the country very soon.

Yes. Like all medical devices, the Rapid Response COVID-19 Rapid Antigen Testing device has an expiration date listed on the outside of the kit box as well as the Cassette testing device package. This expiration date is approximately 1 year from the manufacturing date. 

This timeline is given for informational purposes only. Always refer to expiration date on the packaging.

The BTNX nasal swabs are sterilized using ethylene oxide. This process is completely safe for the user and has been used for decades on medical equipment. The sterilization process follows ISO 11135 (Sterilization of health-care products) and ISO 10993 (Biological evaluation of medical devices). Additionally, all nasal swabs have passed testing for both toxicology and biocompatibility. 

Rapid tests should be stored in a cool, dry place. Please refer to the side of the rapid test kit packaging for the exact temperature requirements.

As the weather gets colder in Canada, we understand some customers may be concerned about the sub-zero temperatures during the shipment of Rapid Test Kits.

Transport temperatures dipping below 0°C for short durations of time will not have an adverse effect on the test, or the buffer liquid.

Recommendation:
It’s important to bring the tests to room temperature before adding the sample into the test, as low ambient temperatures when conducting the test may cause false results. We recommend letting the test kit contents sit out for 4-6 hours before use.

Impact of the Omicron variant of SARS-CoV-2 on BTNX’s Rapid Response® COVID-19 Antigen Rapid Test Device

Statement from device manufacturer:

View full statement here.

You may collect your sample using either method, however collecting an anterior nasal swab only requires you to insert the swab 0.5 inches (1-2cm) into the nostril making it a simpler method of collection and leading to less discomfort that the nasopharyngeal collection. Both the nasopharyngeal and anterior nasal swab collection methods are capable of being used for rapid antigen testing to detect the SARS-CoV-2 nucleoprotein.