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BinaxNOW™ COVID-19 Ag card and NAVICA™ mobile app
$600.00 per Box (of 40 tests)
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.
TAKING COVID-19 TESTING PROGRAMS TO A NEW LEVEL
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. Abbott believes the NAVICA app and Binax NOW COVID test will help us recover a bit more freedom, confidence and normalcy in our everyday lives.
In combination with this Binax NOW COVID test, the 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. After participants complete their Binax NOW COVID test, 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).
Abbott and United partner to restore confidence in daily life
Since newly issued guidance from the U.S. Centers for Disease Control and Prevention now accepts rapid, self-administered testing option that meet its criteria, United and Abbot have partnered to allow customers to depart the United States with the BinaxNOW Home Test in their carry-on bag and administer the test via the eMed digital health platform while overseas, avoiding the need to find a testing center abroad.
BINAXNOW COVID-19 Ag Card: A breakthrough antigen test
- Cost-effective, high performing test designed for decentralized testing
- Visually read results in 15 minutes – no instrument required
- Simple test procedure using a direct nasal swab
- Onboard extraction allows the swab to be directly inserted into the test card
- Room temperature storage
- Emergency Use Authorization (EUA) supports testing in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation
Want to learn more about picking the perfect COVID-19 test for your situation? Check out our blog on this topic here.
TheBinaxNOWTM COVID-19 Ag Card is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct anterior nasal (nares) swabs from individuals suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform moderate, high or waived complexity tests. This test is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
- Instructions for Use
- Video Instructions from Abbott
- BinaxNOW COVID-19 Ag Card – EUA
- BinaxNOW COVID-19 Ag Card – Fact Sheet for Healthcare Providers
- BinaxNow COVID-19 Ag Card – Fact Sheet for Patients
- Method: Lateral Flow
- Time to Result: 15 minutes
- Sample Type: Direct nasal swab
- Performance: Direct nasal swabs taken from individuals suspected of COVID-19 by their healthcare provider within seven days of symptom onset.
- Sensitivity (PPA) 84.6%
- Specificity (NPA) 98.5%
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.
- Kit Size: 40 Tests
- Kit Contents:
- 40 Test Cards
- 40 Nasal Swabs
- Positive Control Swab
- Reagent Bottle
- Package Insert
- Procedure Card
- 40 Patient COVID-19 Fact Sheets
- Healthcare Provider COVID-19 Fact Sheet
- Nasal swab
- NAVICA Administrator Quick Reference Sheet (English)
- NAVICA BinaxNOW COVID-19 Ag Card Product Brochure for Consumers (English)
- NAVICA BinaxNOW COVID-19 Ag Card Product Brochure for Professionals (English)
- NAVICA Managing Team Members Connect Quick Reference Guide (English)
- NAVICA Managing Testing Sites Connect Quick Reference Guide (English)
- NAVICA System Product Sheet (English)
- Credit Card
- Purchase Order