Designed to restore confidence in daily life
The 15-minute BinaxNOW™ COVID-19 Ag Card, a rapid antigen test, was designed alongside the revolutionary NAVICA™ digital system for testing in CLIA-waived settings like universities, offices, pharmacies, long term care facilities.
This first-of-its-kind NAVICA app, available at no-charge, allows people who test negative to get a temporary digital NAVICA Pass, similar to an airline boarding pass. Organizations will be able to verify an individual’s negative COVID-19 test results by scanning the individual’s digital NAVICA Pass to facilitate entry into facilities, along with the vaccine, hand-washing, social distancing, enhanced cleaning, and mask-wearing.
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.
Intended Use |
BinaxNOW COVID-19 Ag Card
|
BinaxNOW COVID-19 Ag 2 Card
|
| No serial testing, symptomatic individuals within 7 days of symptom onset | YES | NO |
Serial testing, symptomatic or asymptomatic individuals, when tested twice over three days with at least 36 hours between tests |
NO | YES |
| Rx required | YES | NO |
| Results can be captured with NAVICA App | YES | YES |
Our rapid COVID-19 tests and NAVICA system work together as a comprehensive solution to easily view, share, confirm and manage COVID-19 test results.
Abbott believes the NAVICA app and BinaxNOW COVID-19 Ag Card test will help us recover a bit more freedom, confidence and normalcy in our everyday lives.
Please note: The FDA has authorized EUA for the asymptomatic claim based on the current data with the stipulation that Abbott will have a post authorization commitment to complete a serial clinical study (protocol agreed with FDA). Upon completion of that study, the BinaxNOW COVID-19 Ag 2 Card performance section will be updated.
| BinaxNOW™ COVID-19 Ag Card | Code |
|---|---|
| BinaxNOW™ COVID-19 Ag Card (40CT) | 195-000 |
| BinaxNOW™ COVID-19 Ag 2 Card (40CT) | 195-400 |
| BinaxNOW™ COVID-19 Ag Card Control Kit (10 Positive) | 195-080 |
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*The BinaxNOW COVID-19 Ag Card and BinaxNOW COVID-19 Ag 2 Card have not been FDA cleared or approved. They have been authorized by the FDA under an emergency use authorization. They have been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens, and are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics 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.
**Refer to the product package insert for full instructions and clinical data.
† Before testing patients, federal regulations require testing sites to have a CLIA certificate issued by CMS. Sites performing only waived tests must obtain a Certificate of Waiver by applying for this certification for each location performing testing. Learn more about CLIA
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