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When it comes to testing for COVID-19, your patients are looking for answers — and you’re looking for a fast, easy and cost-effective way to help. Abbott has designed the BinaxNOW™ COVID-19 Ag Card for decentralized testing, so you can test right at the point of care and get results for your patients quickly and easily. FAST, EASY AND COST-EFFECTIVE COVID-19 TESTING BinaxNOW COVID-19 Ag CARD
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FAST, EASY AND COST-EFFECTIVE COVID-19 TESTING

Feb 27, 2022

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Page 1: FAST, EASY AND COST-EFFECTIVE COVID-19 TESTING

When it comes to testing for COVID-19, your patients are looking for answers — and you’re looking for a fast, easy and cost-effective way to help. Abbott has designed the BinaxNOW™ COVID-19 Ag Card for decentralized testing, so you can test right at the point of care and get results for your patients quickly and easily.

FAST, EASY AND COST-EFFECTIVE COVID-19 TESTINGBinaxNOW™ COVID-19 Ag CARD

Page 2: FAST, EASY AND COST-EFFECTIVE COVID-19 TESTING

A COST-EFFECTIVE, EASY-TO-USE RAPID ANTIGEN TEST

• Simple, CLIA-waived test procedure*

• Direct nasal swab

• No instrument necessary

• Visually read results in 15 minutes

BinaxNOW™ COVID-19 Ag CARD

EASY TO USE. RESULTS IN 15 MINUTES.

NAVICA™ DIGITAL PLATFORM FOR SUPPORTING COVID-19 TESTING The BinaxNOW COVID-19 Ag Card test can be used with the NAVICA™ System, which includes a suite of mobile applications and an easy-to-use online portal to help you and your patients make informed decisions with greater confidence. You can use the NAVICA System to manage automated reporting of BinaxNOW COVID-19 Ag Card test results to state public health agencies.

Page 3: FAST, EASY AND COST-EFFECTIVE COVID-19 TESTING

Add the extraction reagent

1

4 Close the test card; wait 15 minutes

5 Results are read visually

2 Insert the sample nasal swab

3 Rotate the nasal swab shaft three times

NEGATIVERESULT

POSITIVERESULT

PINK/PURPLE CONTROL LINE

PINK/PURPLE SAMPLE LINE

15MIN3X

BinaxNOW™

COVID-19 Ag CARD

SAMPLE

CONTROL

FAST, EASY TEST PROCEDURE**

PERFORMANCE

Sensitivity (PPA) 84.6% Specificity (NPA) 98.5%

Direct nasal swabs taken from individuals suspected of COVID-19 by their healthcare provider within seven days of symptom onset.

Page 4: FAST, EASY AND COST-EFFECTIVE COVID-19 TESTING

KIT CONTENTS

*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.**Refer to the product package insert for full instructions.App Store is a registered trademark of Apple Inc.Google Play is a trademark of Google LLC.The BinaxNOW™ COVID-19 Ag Card is indicated for individuals suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset.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. It 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 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.© 2021 Abbott. All rights reserved. All trademarks referenced are trademarks of either the Abbott group of companies or their respective owners. Any photos displayed are for illustrative purposes only. Any person depicted in such photos is a model. COL-02731-04 08/21

FOR MORE INFORMATION, CONTACT YOUR LOCAL ABBOTT REPRESENTATIVE OR VISIT BINAXNOW.NAVICA.ABBOTT

ORDER INFORMATION

PRODUCT NAME PRODUCT CODEBinaxNOW™ COVID-19 Ag CARD 40 CT 195-000

BinaxNOW™ COVID-19 Ag CARD CONTROL KIT (10 POSITIVE) 195-080

COVID-19 SWAB TRANSPORT TUBEACCESSORY PACK 24 CT 190-010

• 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