Rapid Response | BTNX COVID-19 Antigen Rapid Test Device (Pack of 5)
MANUFACTURER PRODUCT DESCRIPTION
Omicron Variant Update: Click Here to read more about the impact of the Omicron variant of SARS-CoV-2 on BTNX’s Rapid Response® COVID-19 Antigen Rapid Tests
The Rapid Response™ COVID-19 Antigen Rapid Test Device is an in vitro immunochromatographic assay for the direct and qualitative detection of SARS-CoV-2 viral nucleoprotein antigens from nasal and nasopharyngeal secretions from individuals suspected of COVID-19 within 6 days of symptom onset and from individuals without symptoms or other epidemiological reasons to suspect COVID-19 infection, when tested twice over two (or three) days with at least 24 hours (and no more than 36 hours) between tests. This test is authorized for use at the Point of Care i.e., in inpatient care setting. This product is available in both 5 tests per kit and 25 tests per kit sizes.
Product Code: COV-19C25
Sample: Nasal / Nasopharyngeal secretions
Quantity: 5 Tests/Kit or 25 Tests/Kit
Time to result: 15 minutes
Storage Condition: 2-30°C/36-86°F
Test Principle: Immunochromatographic Assay
WHAT IS INCLUDED IN EACH PACK
5 or 25 Individually Packed Test Devices*
- 5 pack ‐ 5 Single-use Buffer Vials
- 25 pack ‐ 25 Single-use Buffer Vials and/or 2 Bottles of Buffer
5 or 25 Nozzles with Filters*
1 Tube Stand
5 or 25 Individually Packed Swabs*
*Quantity dependent on kit size
- See the Ontario Ministry of Health’s Guidelines for using the Rapid Response COVID-19 Antigen Tests Here
- See the Ontario Ministry of Health Training Video for COVID-19 Antigen Rapid Testing
- Canada Centre of Occupational Health and Safety
Pursuant to section 5 of the Interim Order Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19, made by the Minister of Health on March 18, 2020, the Rapid Response™ COVID-19 Antigen Rapid Test Device is now authorized for sale or importation in Canada. Interim Authorization Number: 321669
This test device is not sold to customers in the USA or shipped to the USA.
Upload test results to your database with our RapidReader App.
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. Please learn more about Rapid Antigen tests on the Health Canada website.
The current guidance in Alberta, British Columbia, Ontario, and Saskatchewan is that properly trained individuals may perform self-swabbing. By purchasing this testing device you confirm that the personnel who will use this device will read the product user manual and be trained properly before using it.
CONDUCTING RAPID TESTING
- Asymptomatic workers should be tested at least twice per week.
- Rapid testing can be performed by a health care professional or a trained individual that has the appropriate knowledge and skills to perform the test correctly, depending on the requirements in place for your jurisdiction.
- Specimen collection for rapid testing may also be done by the person being tested (i.e., self-swabbing) if a trained individual is supervising them.
- Training resources are available from your province or territory (Alberta, British Columbia, Saskatchewan, and Ontario).
- Make sure that COVID-19 precautions are in place during rapid testing.
- Make sure that the tester is wearing adequate personal protective equipment (PPE), including:
- Eye protection
- Long-sleeved gown
- Medical mask
- Participants should properly wear a well-constructed and well-fitting mask.
- Clean and disinfect surfaces between users.
- Practice good hand hygiene.
- Maintain physical distancing as much as possible (e.g., when workers are waiting for a test).
- Conduct the testing in a well-ventilated space.
** All Rapid Tests are FINAL SALE – we cannot offer cancellations or refunds after your order has been processed and/or shipped. **