Welcome to the BinaxNOW™ COVID-19 Ag Card and NAVICA™ app
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 complementary NAVICA app is a mobile app intended to be used with BinaxNOW COVID-19 Ag Card. The BinaxNOW™ COVID-19 Ag Card test has received U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA).*
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.
As a NAVICA-enabled test center, you will use the NAVICA Administrator App to communicate encrypted BinaxNOW™ COVID-19 Ag Card test results to participants, allowing them to obtain a digital NAVICA Pass with a negative test result.
Access to the NAVICA Administrator App is available now. We are here to help you through the process. Please click on the button below to complete the form and we will contact you with app access.
The following documents provide additional resources for testers to help ensure proper test procedures are followed.
Additional questions may be added as they arise, so check back here regularly for updates.
HHS is allocating a supply of product through each state’s Governor’s office.
HHS is allocating a supply of product through each state’s Governor’s office. Information on product supply and availability will be forthcoming.
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 97.1% (positive percent agreement) 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. Download the informational sheet.
This training website is devoted to all the training materials needed to set-up your testing locations.
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 NAVICA™ app is your pass to navigating daily life in a new normal. NAVICA displays results from the 15-minute Abbott BinaxNOW COVID-19 Ag Card, a rapid antigen test, to help you and others make informed decisions.
If person’s test results are negative, the NAVICA app will display a temporary digital health pass. Organizations will be able to view and verify a person’s digital NAVICA health pass on their mobile device to facilitate entry into facilities, along with handwashing, social distancing, enhanced cleaning and mask-wearing.
More information on the role of the NAVICA app in your testing program will be forthcoming.
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 firstname.lastname@example.org.
*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 Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
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