Performance and Implementation Evaluation of the Abbott BinaxNOW Rapid Antigen Test in a High-Throughput Drive-Through Community Testing Site in Massachusetts

Author:

Pollock Nira R.1ORCID,Jacobs Jesica R.23,Tran Kristine2,Cranston Amber E.2,Smith Sita2,O’Kane Claire Y.2,Roady Tyler J.2,Moran Anne4,Scarry Alison4,Carroll Melissa4,Volinsky Leila4,Perez Gloria4,Patel Pinal2,Gabriel Stacey5,Lennon Niall J.5,Madoff Lawrence C.26,Brown Catherine2,Smole Sandra C.2

Affiliation:

1. Department of Laboratory Medicine, Boston Children’s Hospital, Boston, Massachusetts, USA

2. Massachusetts Department of Public Health, Jamaica Plain, Massachusetts, USA

3. Laboratory Leadership Service, Centers for Disease Control and Prevention, Atlanta, Georgia, USA

4. Lawrence General Hospital, Lawrence, Massachusetts, USA

5. Broad Institute of MIT and Harvard, Cambridge, Massachusetts, USA

6. Division of Infectious Disease and Immunology, Department of Medicine, University of Massachusetts Medical Center, Worcester, Massachusetts, USA

Abstract

Rapid diagnostic tests (RDTs) for SARS-CoV-2 antigens (Ag) that can be performed at point of care (POC) can supplement molecular testing and help mitigate the COVID-19 pandemic. Deployment of an Ag RDT requires an understanding of its operational and performance characteristics under real-world conditions and in relevant subpopulations.

Funder

Massachusetts Department of Public Health

HHS | Centers for Disease Control and Prevention

Publisher

American Society for Microbiology

Subject

Microbiology (medical)

Reference27 articles.

1. Evaluation of the accuracy, ease of use and limit of detection of novel, rapid, antigen-detecting point-of-care diagnostics for SARS-CoV-2

2. Head-to-head comparison of SARS-CoV-2 antigen-detecting rapid test with self-collected nasal swab versus professional-collected nasopharyngeal swab

3. Becton Dickinson and Company. 2021. Package insert for the BD VeritorTM system for rapid detection of SARS-CoV-2. https://www.fda.gov/media/139755/download.

4. Quidel Corporation. 2020. Package insert for the Sofia SARS antigen FIA test. https://www.fda.gov/media/137885/download.

5. Abbott Laboratories. 2020. Package insert for the Abbott BinaxNOW COVID-19 Ag card. https://www.fda.gov/media/141570/download.

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