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

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...

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Main Authors: Jennifer K. Frediani, Joshua M. Levy, Anuradha Rao, Leda Bassit, Janet Figueroa, Miriam B. Vos, Anna Wood, Robert Jerris, Van Leung-Pineda, Mark D. Gonzalez, Beverly B. Rogers, Maud Mavigner, Raymond F. Schinazi, Nils Schoof, Jesse J. Waggoner, Russell R. Kempker, Paulina A. Rebolledo, Jared W. O’Neal, Cheryl Stone, Ann Chahroudi, Claudia R. Morris, Allie Suessmith, Julie Sullivan, Sarah Farmer, Amanda Foster, John D. Roback, Thanuja Ramachandra, CaDeidre Washington, Kristie Le, Maria C. Cordero, Annette Esper, Eric J. Nehl, Yun F. Wang, Erika A. Tyburski, Greg S. Martin, Wilbur A. Lam
Format: Article
Language:English
Published: Nature Publishing Group 2021-07-01
Series:Scientific Reports
Online Access:https://doi.org/10.1038/s41598-021-94055-1
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author Jennifer K. Frediani
Joshua M. Levy
Anuradha Rao
Leda Bassit
Janet Figueroa
Miriam B. Vos
Anna Wood
Robert Jerris
Van Leung-Pineda
Mark D. Gonzalez
Beverly B. Rogers
Maud Mavigner
Raymond F. Schinazi
Nils Schoof
Jesse J. Waggoner
Russell R. Kempker
Paulina A. Rebolledo
Jared W. O’Neal
Cheryl Stone
Ann Chahroudi
Claudia R. Morris
Allie Suessmith
Julie Sullivan
Sarah Farmer
Amanda Foster
John D. Roback
Thanuja Ramachandra
CaDeidre Washington
Kristie Le
Maria C. Cordero
Annette Esper
Eric J. Nehl
Yun F. Wang
Erika A. Tyburski
Greg S. Martin
Wilbur A. Lam
spellingShingle Jennifer K. Frediani
Joshua M. Levy
Anuradha Rao
Leda Bassit
Janet Figueroa
Miriam B. Vos
Anna Wood
Robert Jerris
Van Leung-Pineda
Mark D. Gonzalez
Beverly B. Rogers
Maud Mavigner
Raymond F. Schinazi
Nils Schoof
Jesse J. Waggoner
Russell R. Kempker
Paulina A. Rebolledo
Jared W. O’Neal
Cheryl Stone
Ann Chahroudi
Claudia R. Morris
Allie Suessmith
Julie Sullivan
Sarah Farmer
Amanda Foster
John D. Roback
Thanuja Ramachandra
CaDeidre Washington
Kristie Le
Maria C. Cordero
Annette Esper
Eric J. Nehl
Yun F. Wang
Erika A. Tyburski
Greg S. Martin
Wilbur A. Lam
Multidisciplinary assessment of the Abbott BinaxNOW SARS-CoV-2 point-of-care antigen test in the context of emerging viral variants and self-administration
Scientific Reports
author_facet Jennifer K. Frediani
Joshua M. Levy
Anuradha Rao
Leda Bassit
Janet Figueroa
Miriam B. Vos
Anna Wood
Robert Jerris
Van Leung-Pineda
Mark D. Gonzalez
Beverly B. Rogers
Maud Mavigner
Raymond F. Schinazi
Nils Schoof
Jesse J. Waggoner
Russell R. Kempker
Paulina A. Rebolledo
Jared W. O’Neal
Cheryl Stone
Ann Chahroudi
Claudia R. Morris
Allie Suessmith
Julie Sullivan
Sarah Farmer
Amanda Foster
John D. Roback
Thanuja Ramachandra
CaDeidre Washington
Kristie Le
Maria C. Cordero
Annette Esper
Eric J. Nehl
Yun F. Wang
Erika A. Tyburski
Greg S. Martin
Wilbur A. Lam
author_sort Jennifer K. Frediani
title Multidisciplinary assessment of the Abbott BinaxNOW SARS-CoV-2 point-of-care antigen test in the context of emerging viral variants and self-administration
title_short Multidisciplinary assessment of the Abbott BinaxNOW SARS-CoV-2 point-of-care antigen test in the context of emerging viral variants and self-administration
title_full Multidisciplinary assessment of the Abbott BinaxNOW SARS-CoV-2 point-of-care antigen test in the context of emerging viral variants and self-administration
title_fullStr Multidisciplinary assessment of the Abbott BinaxNOW SARS-CoV-2 point-of-care antigen test in the context of emerging viral variants and self-administration
title_full_unstemmed Multidisciplinary assessment of the Abbott BinaxNOW SARS-CoV-2 point-of-care antigen test in the context of emerging viral variants and self-administration
title_sort multidisciplinary assessment of the abbott binaxnow sars-cov-2 point-of-care antigen test in the context of emerging viral variants and self-administration
publisher Nature Publishing Group
series Scientific Reports
issn 2045-2322
publishDate 2021-07-01
description 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.
url https://doi.org/10.1038/s41598-021-94055-1
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spelling doaj-30016094be9f470888a58161d2407fd52021-07-18T11:24:29ZengNature Publishing GroupScientific Reports2045-23222021-07-011111910.1038/s41598-021-94055-1Multidisciplinary assessment of the Abbott BinaxNOW SARS-CoV-2 point-of-care antigen test in the context of emerging viral variants and self-administrationJennifer K. Frediani0Joshua M. Levy1Anuradha Rao2Leda Bassit3Janet Figueroa4Miriam B. Vos5Anna Wood6Robert Jerris7Van Leung-Pineda8Mark D. Gonzalez9Beverly B. Rogers10Maud Mavigner11Raymond F. Schinazi12Nils Schoof13Jesse J. Waggoner14Russell R. Kempker15Paulina A. Rebolledo16Jared W. O’Neal17Cheryl Stone18Ann Chahroudi19Claudia R. Morris20Allie Suessmith21Julie Sullivan22Sarah Farmer23Amanda Foster24John D. Roback25Thanuja Ramachandra26CaDeidre Washington27Kristie Le28Maria C. Cordero29Annette Esper30Eric J. Nehl31Yun F. Wang32Erika A. Tyburski33Greg S. Martin34Wilbur A. Lam35Nell Hodgson Woodruff School of Nursing, Emory UniversityThe Atlanta Center for Microsystems-Engineered Point-of-Care TechnologiesThe Atlanta Center for Microsystems-Engineered Point-of-Care TechnologiesThe Atlanta Center for Microsystems-Engineered Point-of-Care TechnologiesThe Atlanta Center for Microsystems-Engineered Point-of-Care TechnologiesThe Atlanta Center for Microsystems-Engineered Point-of-Care TechnologiesThe Atlanta Center for Microsystems-Engineered Point-of-Care TechnologiesThe Atlanta Center for Microsystems-Engineered Point-of-Care TechnologiesThe Atlanta Center for Microsystems-Engineered Point-of-Care TechnologiesThe Atlanta Center for Microsystems-Engineered Point-of-Care TechnologiesThe Atlanta Center for Microsystems-Engineered Point-of-Care TechnologiesThe Atlanta Center for Microsystems-Engineered Point-of-Care TechnologiesThe Atlanta Center for Microsystems-Engineered Point-of-Care TechnologiesThe Atlanta Center for Microsystems-Engineered Point-of-Care TechnologiesThe Atlanta Center for Microsystems-Engineered Point-of-Care TechnologiesThe Atlanta Center for Microsystems-Engineered Point-of-Care TechnologiesThe Atlanta Center for Microsystems-Engineered Point-of-Care TechnologiesThe Atlanta Center for Microsystems-Engineered Point-of-Care TechnologiesThe Atlanta Center for Microsystems-Engineered Point-of-Care TechnologiesThe Atlanta Center for Microsystems-Engineered Point-of-Care TechnologiesThe Atlanta Center for Microsystems-Engineered Point-of-Care TechnologiesThe Atlanta Center for Microsystems-Engineered Point-of-Care TechnologiesThe Atlanta Center for Microsystems-Engineered Point-of-Care TechnologiesThe Atlanta Center for Microsystems-Engineered Point-of-Care TechnologiesThe Atlanta Center for Microsystems-Engineered Point-of-Care TechnologiesThe Atlanta Center for Microsystems-Engineered Point-of-Care TechnologiesThe Atlanta Center for Microsystems-Engineered Point-of-Care TechnologiesThe Atlanta Center for Microsystems-Engineered Point-of-Care TechnologiesThe Atlanta Center for Microsystems-Engineered Point-of-Care TechnologiesThe Atlanta Center for Microsystems-Engineered Point-of-Care TechnologiesThe Atlanta Center for Microsystems-Engineered Point-of-Care TechnologiesThe Atlanta Center for Microsystems-Engineered Point-of-Care TechnologiesThe Atlanta Center for Microsystems-Engineered Point-of-Care TechnologiesThe Atlanta Center for Microsystems-Engineered Point-of-Care TechnologiesThe Atlanta Center for Microsystems-Engineered Point-of-Care TechnologiesThe Atlanta Center for Microsystems-Engineered Point-of-Care TechnologiesAbstract 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.https://doi.org/10.1038/s41598-021-94055-1