Instructions & Demonstration
Please watch the video below for guidance on how to collect nasal specimens and administer the BTNX Rapid Response Rapid COVID-19 Antigen Test.
BTNX Rapid Response
Rapid Antigen Test Features
● Easy-to-use test - results in 15 minutes
● Individually packed buffer liquid
● Health Canada Authorized testing device
● Available in 5-packs at just $9.99/test
How It Works
ANTIGEN TESTING DEVICES INFORMATION & RESOURCES
Information, regulations, and guidance around the use of rapid antigen testing devices in Canada is frequently changing. While The Canadian Shield website is updated often, we recommend referring to the Health Canada website for the most up to date information on rapid antigen testing in Canada.
The Canadian Shield is the proud holder of a Health Canada Medical Device Establishment Licenses which permits us to manufacture and distribute medical devices in Canada.
MDEL License #: 11655 Company ID: 151799
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.
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.
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 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.
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.
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.
BTNX’s Rapid Response COVID-19 Antigen Test Device is designed to detect the SARS-CoV-2 viral nucleocapsid proteins. Mutations of the nucleocapsid proteins for the Omicron variant include P13L, Δ31-33, R203K, and G204R. BTNX has urgently analyzed the sequences from the Omicron variant to understand the implication of these mutations.
Based on the preliminary analysis, we anticipate that the Omicron variant will be detectable by the Rapid Response COVID-19 Antigen Test Device. BTNX will conduct in-vitro studies to confirm the effect on test performance. The results will be made available as soon as the investigations are concluded. BTNX continues to follow the latest findings on COVID-19 and remain committed to maintaining the highest level of excellency in our products.
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.
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.
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.