BINAXNOW™ COVID-19 AG CARD AND NAVICA™ APP SET-UP AND TRAINING

• Introduction to CLIA-Waived Testing Document
• BinaxNOW™ COVID-19 Ag Card Clinical and Laboratory Standards Institute (CLSI) Document
• BinaxNOW™ COVID-19 Ag Card Product Insert
• BinaxNOW™ COVID-19 Ag Card Procedure Card
• BinaxNOW™ COVID-19 Nasal Swab Tech Tips
• BinaxNOW™ COVID-19 Ag Card Patient Fact Sheet
• BinaxNOW™ COVID-19 Ag Card Healthcare Provider Fact Sheet
• BinaxNOW™ COVID-19 Ag Card Patient Fact Sheet - Spanish
• BinaxNOW™ COVID-19 Ag Card Healthcare Provider Fact Sheet - Spanish
• BinaxNOW™ COVID-19 Ag Card Product Expiry Update (English)

• BinaxNOW™ COVID-19 Ag Card &  NAVICA™ App Customer Training
• NAVICA Administrator for BinaxNOW™ COVID-19 Ag Card Customer Training
• NAVICA Administrator Quick Reference Guide
• NAVICA Connect: Managing Testing Sites Quick Reference Guide
• NAVICA Connect: Managing Team Members Quick Reference Guide
• NAVICA Connect: Managing Participants Quick Reference Guide
• NAVICA Consumer: Create an Account and Set up the App Quick Reference Guide
• NAVICA Consumer: Connect to an Organization Quick Reference Guide
• NAVICA Verifier Customer Training Presentation
• NAVICA Verifier: Account Creation and App Setup Quick Reference Guide
• NAVICA Verifier: Authenticate a Pass Quick Reference Guide

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

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:

• Order through existing account and process
• Standard freight charges apply

Customers without an ARDx Account:

• Orders can be taken via telephone only
  -  Contact Abbott Customer Support at 877-441-7440 Option 1
• Only credit card payments can be accepted
• Freight Charges
  -  1-5 kits: $5 Flat Rate
  -  6-10 kits: $10 Flat Rate
  -  11-20 kits: $15 Flat Rate
  -  20+ kits: $25 Flat Rate
  
• Orders will be placed as a onetime order no matter how many times reorders are placed
  
• No account set up required
  
• The customer’s credit card will be authorized while on the phone and processed once the product has shipped
  

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:

• For each shipment: 1 set of QC swabs (positive and negative) is run to validate the shipment, then 1 operator can be trained for every test kit received in that shipment. 
  • 5 kits received: 4 operators can be trained (1 QC of shipment, 4 operators can be trained) 
  • 10 kits received: 9 operators can be trained (1 QC of shipment, 9 operators can be trained) 
  • 50 kits received: 49 operators can be trained (1 QC of shipment, 49 operators can be trained) 
• If there are more operators than test kits: 
  • 2 kits received with 4 operators to be trained – 1 QC of shipment, 1 operator can be trained with the 2 kits received. Will need to request 1 BinaxNOW COVID-19 Ag Card Control Kit from HHS.
  • Please note: 1 control kit can train up to 10 operators

If you have more operators than test kits, below is the ordering information for additional swabs:

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 ts.scr@abbott.com.