Assessment of the Abbott BinaxNOW SARS-CoV-2 rapid antigen test against viral variants of concern

• Type of Material: Article
• Authors: Anuradha Rao, Emory University; Leda Bassit, Emory University; Jessica Lin, Emory University; Kiran Verma, Emory University; Heather B. Bowers, Emory University; Kimberly Pachura, Emory University; Morgan Greenleaf, Emory University; Julie Sullivan, Emory University; Eric Lai, NaviDx, LLC; Richard S. Creager, NaviDx, LLC; Thomas Pribyl, Biocomx; John Blackwood, Biocomx; Anne Piantadosi, Emory University; Raymond Schinazi, Emory University; Gregory Martin, Emory University; Wilbur Lam, Emory University
• Language: English
• Date: 2022-03-18
• Publisher: Elsevier
• Publication Version: Final Published Version
• Copyright Statement: © 2022 The Author(s)
• License: Creative Commons Attribution 4.0 International
• Final Published Version (URL): http://dx.doi.org/10.1016/j.isci.2022.103968
• Title of Journal or Parent Work: iScience
• Volume: 25
• Issue: 3
• Start Page: 103968
• End Page: 103968
• Grant/Funding Information: Abbott BinaxNOW COVID-19 Antigen Self-Test was graciously provided by the U.S. Department of Health and Human Services and Bruce J. Tromberg of the National Institute of Biomedical Imaging and Bioengineering of the NIH. This work is supported by NIH Grants U54 EB027690 02S1, U54 EB027690 03S1, U54 EB027690 03S2, UL1 TR002378. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
• Keywords: Biological sciences; Public health; Diagnostics; Biotechnology; Virology
• Research Categories: Health Sciences, Immunology; Biology, Virology

Abstract

As the emergence of SARS-CoV-2 variants brings the global pandemic to new levels, the performance of current rapid antigen tests against variants of concern and interest (VOC/I) is of significant public health concern. Here, we report assessment of the Abbot BinaxNOW COVID-19 Antigen Self-Test. Using genetically sequenced remnant clinical samples collected from individuals positive for SARS-CoV-2, we assessed the performance of BinaxNOW against the variants that currently pose public health threats. We measured the limit of detection of BinaxNOW against various VOC/I in a blinded manner. BinaxNOW successfully detected the Omicron (B.1.1.529), Mu (B.1.621), Delta (B.1.617.2), Lambda (C.37), Gamma (P.1), Alpha (B.1.1.7), Beta (B.1.351), Eta (B.1.525), and P.2 variants and at low viral concentrations. BinaxNOW also detected the Omicron variant in individual remnant clinical samples. Overall, these data indicate that this inexpensive and simple-to-use, FDA-authorized and broadly distributed rapid test can reliably detect Omicron, Delta, and other VOC/I.