COVID-19 Antigen Rapid Test Device

Product Information
Product Code: COV-19C25
Sample: Nasal / Nasopharyngeal secretions
Format: Cassette
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
Contents
5 or 25 Individually Packed Test Devices*
Extraction Buffer
  • 5 pack ‐ 5 Single use Buffer Vials
  • 25 pack ‐ 25 Single use Buffer Vials and/or 2 Bottles of Buffer
5 or 25 Extraction Tubes*
5 or 25 Nozzles with Filters*
1 Tube Stand
5 or 25 Individually Packed Swabs*
Package Insert
*Quantity dependent on kit size
Product Description

Voir cette page en français

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.

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 patient care setting. This product is available in both 5 tests per kit and 25 test per kit sizes.


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FAQ
For asymptomatic patients, it is recommended to repeat the test once a day for several days.
No, we do not sell the Rapid Response COVID-19 Antigen test for personal use.
Every region has its own requirements for testing before travel. Many require proof of the test results from a qualified lab or healthcare professional. Please refer to the regional requirements applicable to your travel plans.
Please refer to your employer’s instruction and testing policy for details.
It is an antigen test that can be used for point-of-care testing (POCT) to screen for COVID-19. Antigen POCT can be used as an additional screening tool. 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.
Results of the Rapid Response COVID-19 Antigen Rapid Test can be read at 15 minutes. Results should be read at 15 minutes, but not later than 30 minutes. If any lines show up after 30 minutes, they should not be considered as true results. Please refer to the product insert for instructions on conducting and interpreting the test.
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.
If the test result is negative, viral antigens were not detected in the sample. Negative results do not rule out SARS-CoV-2 infection. All negative results are considered presumptive. The amount of antigen in a sample may decrease as the duration of illness increases, or it may be too early for there to be high enough levels of the antigen in the sample. Negative results should be considered in the context of an individual’s recent exposures, history, and the presence of clinical signs and symptoms consistent with COVID-19 and confirmed with a molecular assay, if necessary.
After adding three drops to the sample well wait 15 minutes, then read the test results. Results are interpreted as follows:
Two coloured lines appear in the long test window. One line appears in the control region (C) and another line appears in the test region (T).
Only one coloured line appears in the long test window, in the control region (C). No apparent coloured line appears in the test region (T).
A coloured line does not appear in the control region (C). Results from any test which has not produced a control line at the specified read time must be discarded. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor.
Please refer to the product insert for instructions on conducting and interpreting the test.
You may collect your sample from either, but we recommend you collect a nasal sample from both nostrils. Even for experienced professionals like nurses, it is easier to swab the nasal cavity than the nasopharynx. The swab provided in the kit can be used for either collection method.
The instructions provided with each kit box are in both English and French. For information in alternate languages please see the Ontario Ministry of Health’s series of videos on “Rapid Antigen Testing for Asymptomatic Students” at this link.
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 15 minutes. Results should not be interpreted after 30.
After adding three drops to the sample well wait 15 minutes, then read the test results. Results should not be interpreted after 30 minutes.
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.
Results should be read 15 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 30 minutes, as faint lines may occur due to the test strip drying or other factors.
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 (based on the date of their confirmed positive PCR result).
The test must be stored between 2-30°C. All components must be brought to room temperature (15-30°C) before conducting the test.
No, the test must be used in room temperature conditions (15~30°C).
Yes, you may still use the test, bring the test indoors and allow all kit contents to reach room temperature, by waiting for a minimum of 30 minutes. The Rapid Response COVID-19 Rapid Antigen Test has been tested for extreme shipping conditions and its performance has not been impacted.
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.
The test cassettes and the kit contents have the expiration date written on the outer packaging of the box. All tests expire 24 months from their date of manufacture.
Please use the entire contents of the single use vial or 10 drops from the buffer bottle, do not use both for a single test. We recommend using the buffer solution from the single-use vials. The single-use vials reduce the risk of adding insufficient buffer to the extraction tube, which can affect the results of your test. When using the buffer solution from the single-use buffer vial please empty the entire contents of the vial for each test. Please see the instructions provided with your kit for further details.
For details on the composition of the kit components, including the buffer, please see Section 3 of these MSDS / Safety Data Sheet.
Safety Data Sheet COV-19C25 (English)
Safety Data Sheet COV-19C25 (French)
You may access the full MSDS/Safety Data Sheets here:
Safety Data Sheet COV-19C25 (English)
Safety Data Sheet COV-19C25 (French)
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 Device is now authorized for sale or importation in Canada. Interim Authorization Number: 321669

Upload test results to your database with our RapidReader App.

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

For additional information regarding any of our products, please feel free to Contact Us