Welcome to the BinaxNOW™ COVID-19 Ag Card and NAVICA™ app
The resources below are designed to provide the training necessary to successfully test patients using the BinaxNOW COVID-19 Ag Card. These materials are available for your reference as you prepare to implement your site's testing program.
The BinaxNOW™ COVID–19 Ag Card is a rapid antigen test for detecting active infections of COVID-19. The BinaxNOW™ COVID-19 Ag Card test has received U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA).*
The BinaxNOW™ COVID-19 test can be paired with the NAVICA™ System, which provides a comprehensive digital platform for supporting COVID-19 testing. It includes a suite of mobile applications and an easy-to-use online portal that work with the BinaxNOW COVID-19 test to help individuals and organizations make informed decisions with greater confidence.
Only available in the US.
Watch the BinaxNOW™ COVID-19 Ag Card demonstration and NAVICA™ consumer videos prior to the more detailed training to see a brief demonstration of the testing process from start to finish.
The BinaxNOW™ COVID-19 Ag Card training video provides a detailed step-by-step guide to the test process. The training video, divided into modules, should be completed in its entirety before performing tests on individuals. The modules are designed to be completed in the order shown below.
This module will provide an overview of the test, review test kit contents and review kit storage and stability.
Organizations, such as employers or schools, can use the NAVICA System to support their COVID-19 testing program (such as who gets tested and how often), and monitor test results. NAVICA-enabled organizations can use the NAVICA Connect Portal to invite participants to share their COVID-19 test results, providing the organization visibility to its population’s testing status.
If you would like to use the NAVICA System, complete the form below to request access to the NAVICA applications to support your needs.
Additional questions may be added as they arise, so check back here regularly for updates.
Abbott's BinaxNOW™ COVID-19 Ag Card is a rapid antigen test for detection of COVID-19. It is a reliable, highly portable tool for detecting active coronavirus infections. BinaxNOW uses proven Abbott lateral flow technology, used in a number of our rapid tests including strep, flu and legionella – as well as HIV and malaria. The visually read test is about the size of a credit card and requires no equipment and provides results in 15 minutes.
In data submitted to the FDA from a clinical study conducted by Abbott with several leading U.S. research universities, the BinaxNOW COVID-19 Ag Card demonstrated sensitivity of 84.6% (positive percent agreement) for the entire study population, 95.6% for those with PCR cycle threshold (Ct) of <33 and specificity of 98.5% (negative percent agreement) in direct nasal swabs from individuals suspected of COVID-19 by their healthcare provider within the first 7 days of symptom onset.
Wear appropriate personal protection equipment and gloves when running each test and handling patient specimens. Change gloves between handling of specimens suspected of COVID-19. Visit the CDC website for PPE guidance or contact your local Department of Public Health. All components of this kit should be discarded as biohazard waste according to Federal, State and local regulatory requirements.
Yes. The BinaxNOW™ COVID-19 Ag Card has been authorized by the FDA under an Emergency Use Authorization for use at the Point of Care, i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. If you do not have a CLIA certificate, we have an informational sheet that will provide guidance on how to apply for a CLIA certificate. Click here to download the informational sheet.
This website contains BinaxNOW™ COVID-19 Ag Card training materials for your reference. If you are reviewing this FAQ document and not online, here is the link to the website. Click here
Yes. The BinaxNOW COVID-19 Ag Card has been authorized by the FDA under an Emergency Use Authorization for use at the Point of Care, i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. If you do not have a CLIA certificate, we have an informational sheet that will provide guidance on how to apply for a CLIA certificate. Download the informational sheet.
This training website is devoted to all the training materials needed to set-up your testing locations.
Order Number - 190-010
Price: $3.75 per kit (24 Tubes per kit)
Customers with an existing Abbott Rapid Diagnostics (ARDx) Account:
Customers without an ARDx Account:
Good laboratory practice suggests the use of positive and negative controls to ensure that test reagents are working and that the test is correctly performed. BinaxNOW COVID-19 Ag Card kits contain a Positive Control Swab and Sterile Swabs that can be used as a Negative Control Swab. These swabs will monitor the entire assay.
Test these swabs once with each new shipment received and once for each untrained operator. Further controls may be tested in order to conform with local, state and/or federal regulations, accrediting groups, or your lab’s standard Quality Control procedures. Refer to the product insert, found in each test kit, for complete instructions on how to perform Quality Control testing.
If you have numerous operators to train you may need additional Quality Control swabs. Below are examples to help guide you:
If you have more operators than test kits, below is the ordering information for additional swabs:
|BinaxNOW™ COVID-19 Ag Card Control Kit (10 Positive Swabs)||195-080|
All components of the BinaxNOW™ COVID-19 Ag Card test kit should be discarded as biohazard waste according to Federal, State and Local regulatory requirements.
The BinaxNOW™ COVID-19 test can be paired with the NAVICA™ System, which provides a comprehensive digital platform for supporting COVID-19 testing. It includes a suite of mobile applications and an easy-to-use online portal that work with the BinaxNOW™ COVID-19 test to help individuals and organizations make informed decisions with greater confidence. Individuals can use the NAVICA mobile app when getting tested, and to view and share results from the BinaxNOW™ COVID-19 test with a NAVICA Pass (upon a negative test result), similar to an airline boarding pass, at NAVICA-enabled environments such as office buildings and schools to verify a recent negative test for COVID-19. To learn more about NAVICA in general Click here.
For any questions pertaining to the BinaxNOW COVID-19 Ag Card or NAVICA, please contact Abbott Technical Services at 1-800-257-9525 between 8 a.m. – 8 p.m. EST Monday-Friday or by emailing firstname.lastname@example.org.
For any questions pertaining to the BinaxNOW COVID-19 Ag Card or NAVICA, please contact the Abbott Technical Services Team at 1-800-257-9525 between 8 a.m and 8 p.m. EST Monday-Friday or email email@example.com.
Watch this video to learn more about the COVID-19 Swab Transport Tubes.
*The BinaxNOW™ COVID-19 Ag Card has not been FDA cleared or approved. It has been authorized by the FDA under an emergency use authorization for use by authorized laboratories. The test has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens, and is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
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