Multidisciplinary assessment of the Abbott BinaxNOW SARS-CoV-2 point-of-care antigen test in the context of emerging viral variants and self-administration

• Type of Material: Article
• Authors: Jennifer Frediani, Emory University; Joshua Levy, Emory University; Leda Bassit, Emory University; Miriam Vos, Emory University; Robert Jerris, Emory University; Beverly Rogers, Emory University; Maud Mavigner, Emory University; Raymond Schinazi, Emory University; Jesse Waggoner, Emory University; Russell Kempker, Emory University; Paulina Rebolledo, Emory University; Ann Chahroudi, Emory University; Claudia Morris, Emory University; John Roback, Emory University; Annette Esper, Emory University; Eric Nehl, Emory University; Yun Wang, Emory University; Gregory Martin, Emory University; Wilbur Lam, Emory University
• Language: English
• Date: 2021-07-16
• Publisher: NATURE RESEARCH
• Publication Version: Final Published Version
• Copyright Statement: © The Author(s) 2021
• License: Creative Commons Attribution 4.0 International
• Final Published Version (URL): http://dx.doi.org/10.1038/s41598-021-94055-1
• Title of Journal or Parent Work: SCIENTIFIC REPORTS
• Volume: 11
• Issue: 1
• Start Page: 14604
• End Page: 14604
• Grant/Funding Information: RADx, Grant/Award Numbers: U54 EB027690 02S1, UL1 TR002378.
• Keywords: Science & Technology - Other Topics; Science & Technology; Multidisciplinary Sciences
• Research Categories: Health Sciences, Immunology; Biology, Virology; Health Sciences, Health Care Management

Abstract

While there has been significant progress in the development of rapid COVID-19 diagnostics, as the pandemic unfolds, new challenges have emerged, including whether these technologies can reliably detect the more infectious variants of concern and be viably deployed in non-clinical settings as “self-tests”. Multidisciplinary evaluation of the Abbott BinaxNOW COVID-19 Ag Card (BinaxNOW, a widely used rapid antigen test, included limit of detection, variant detection, test performance across different age-groups, and usability with self/caregiver-administration. While BinaxNOW detected the highly infectious variants, B.1.1.7 (Alpha) first identified in the UK, B.1.351 (Beta) first identified in South Africa, P.1 (Gamma) first identified in Brazil, B.1.617.2 (Delta) first identified in India and B.1.2, a non-VOC, test sensitivity decreased with decreasing viral loads. Moreover, BinaxNOW sensitivity trended lower when devices were performed by patients/caregivers themselves compared to trained clinical staff, despite universally high usability assessments following self/caregiver-administration among different age groups. Overall, these data indicate that while BinaxNOW accurately detects the new viral variants, as rapid COVID-19 tests enter the home, their already lower sensitivities compared to RT-PCR may decrease even more due to user error.