BTNX Rapid Response® COVID-19 Antigen Rapid Test Device - At Home

Product Description

Omicron Variant Update: Click Here to read our latest update on the impact of the Omicron variant of SARS-CoV-2 on COVID-19 Antigen Rapid Test Device - At Home.

The Rapid Response® COVID-19 Antigen Rapid Test Cassette - At Home is an in vitro immunochromatographic assay intended to detect nucleocapsid protein antigen from SARS-CoV-2 virus that causes COVID-19 in nasal swab samples from individuals suspected of COVID-19 within 7 days of symptom onset and from individuals without symptoms or other epidemiological reasons to suspect COVID-19 infection. This device is authorized for home-use in a non-laboratory setting with direct anterior nasal (nares) swab samples for:

• Unobserved self-collection for individuals aged 18 years or older
• Adult supervised self-collection for individuals age 14 or older
• Adult collecting from children 2 years or older

This test is authorized for home use only under the Health Canada Interim Order.

FAQ

Did my test get a shelf-life extension? Yes, the shelf-life of this test is now 24 months from the date of manufacture printed on the box. Click this link for further information.

Can I purchase these tests for personal use? Yes, this test is authorized for home use under the Health Canada Interim Order for use in relation to COVID-19.

If I don’t have any symptoms how often should I test? For asymptomatic users, it is recommended to repeat the test once a day for several days.

Can I purchase these tests for personal use? Yes, this test is authorized for home use under the Health Canada Interim Order for use in relation to COVID-19.

How do I submit these tests to my employer? Please refer to your employer’s instruction and testing policy for details.

What is a COVID-19 Antigen Rapid Test? It is an antigen test that can be used as a screening tool for SARS-CoV-2. It does not replace public health measures such as vaccination, symptom screening, physical distancing, masking, and hand hygiene. It does not replace requirements to protect the health and safety of workers.

How long does it take to get results? Results of the Rapid Response® COVID-19 Antigen Rapid Test Cassette – At Home can be read at 10 minutes. Results should be read at 10 minutes, and not later than 20 minutes. If any lines show up after 20 minutes, they should not be considered as true results. Please refer to the product insert for instructions on conducting and interpreting the test.

What further testing do I require if the result is positive? If you have a positive test result, it is very likely that you have COVID-19 because proteins from the virus that causes COVID-19 were found in your sample. There is a very small chance that this test can give a positive result that is wrong (a false positive result). If you test positive with the Rapid Response™ COVID-19 Antigen Home Test you should self-isolate and seek follow-up care with your healthcare provider. Additional testing may be necessary.

What further testing do I require if the result is negative? A negative test result means that proteins from the virus that causes COVID-19 were not detected in your sample. It is possible for this test to give a negative result that is incorrect (a false negative result) for some people with COVID-19. You could still have COVID-19 even though the test is negative. The amount of antigen in a sample may decrease over time and would then be more likely to be negative compared to a molecular assay. If you test negative but continue to have COVID-19 symptoms, seek follow up care from your healthcare provider.

How do I read the results of my test? After adding three drops to the sample well, wait 10 minutes, then read the test results. Results are interpreted as follows: Please refer to the full instructions provided with your test kit before interpreting results.

Are the test instructions available in other languages or translations? The instructions provided with each kit box are in both English and French.

What does it mean if the lines on my test are faint? The colour intensity in the of the lines on your test may vary depending on the concentration of analytes present in the specimen. Therefore, any shade of colour in the test region should be considered positive. Results should be interpreted at 10 minutes. Results should not be interpreted after 20.

How long can I wait before checking my results? After adding three drops to the sample well wait 10 minutes, then read the test results. Results should not be interpreted after 20 minutes.

What is the difference between an antigen and molecular or PCR test? There are different kinds of tests for diagnosing COVID-19. Molecular tests (such as PCR tests) detect genetic material from the virus. Antigen tests, such as this one, detect proteins from the virus. Antigen tests are very specific for the virus but are not as sensitive as molecular tests. This means that while positive results are highly accurate, negative results do not rule out infection.

When should I read the results of the test? Results should be read 10 minutes after the three drops of buffer solution have been added to the sample well on the test cassette. Results should not be interpreted after 20 minutes, as faint lines may occur due to other factors, including the test strip drying.

If an individual previously tested positive for COVID-19, should they be tested with rapid antigen screening? Individuals who have previously been diagnosed with and cleared of COVID-19 infection should resume asymptomatic screening after 90 days from their COVID-19 infection.

How should I store the test? The test must be stored between 2-30°C. All components must be brought to room temperature (15-30°C) before conducting the test.

Can I use the test outdoors in the cold? No, the test must be used in room temperature conditions (15-30°C).

What if my kit is left outside overnight in the cold, can I still use it? Yes, you may still use the test. Bring the test indoors and allow all kit contents to reach room temperature, waiting for a minimum of 30 minutes. The COVID-19 Antigen Rapid Test - At Home can withstand extreme conditions like freezing during transport for brief periods, but it should not be stored in a freezer or frozen and thawed repeatedly.

What chemicals, or ingredients are the kit components made of? For details on the composition of the kit components, including the buffer, please see these MSDS / Safety Data Sheet. Safety Data Sheet COVID-19 Antigen Rapid Test Cassette and Buffer

Where can I access safety data sheet or MSDS for the COVID-19 Antigen Rapid Test - At Home? You may access the full MSDS/Safety Data Sheets for the kit and the buffer here: Safety Data Sheet COVID-19 Antigen Rapid Test Cassette and Buffer

Can this test detect variants? Yes, the test can detect different variants. Detailed information available on request.

Disclaimers and Contact

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 Cassette – At Home is now authorized for sale or importation in Canada. Interim Authorization Number: 342928

For information on purchase orders please contact your local sales representative or contact us at covid19@btnx.com or 1-888-339-9964.

For service in French, please email covid19@btnx.com and we will connect you to one of our partners for assistance. - Pour un service en français, veuillez envoyer un e-mail à covid19@btnx.com et nous vous mettrons en contact avec l'un de nos partenaires pour obtenir de l'aide.