Performance Characteristics of the Abbott BinaxNOW SARS-CoV-2 Antigen Test in Comparison to Real-Time Reverse Transcriptase PCR and Viral Culture in Community Testing Sites during November 2020

Author:

Almendares Olivia1ORCID,Prince-Guerra Jessica L.12ORCID,Nolen Leisha D.1,Gunn Jayleen K. L.1,Dale Ariella P.134,Buono Sean A.12,Deutsch-Feldman Molly14,Suppiah Suganthi1,Hao LiJuan1,Zeng Yan1,Stevens Valerie A.1,Knipe Kristen1,Pompey Justine1,Atherstone Christine14,Bui David P.14,Powell Tracy1,Tamin Azaibi1,Harcourt Jennifer L.1,Petway Marla1,Bohannon Caitlin1,Folster Jennifer M.1,MacNeil Adam1,Salerno Reynolds1,Kuhnert-Tallman Wendi1,Tate Jacqueline E.1,Thornburg Natalie1,Kirking Hannah L.1,Sheiban Khalilullah5,Kudrna Julie5,Cullen Theresa5,Komatsu Kenneth K.3,Villanueva Julie M.1,Rose Dale A.1,Neatherlin John C.1,Anderson Mark1,Rota Paul A.1,Honein Margaret A.1,Bower William A.1,

Affiliation:

1. COVID-19 Response Team, Centers for Disease Control and Prevention, Atlanta, Georgia, USA

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

3. Arizona Department of Health Services, Phoenix, Arizona, USA

4. Epidemic Intelligence Service, Centers for Disease Control and Prevention, Atlanta, Georgia, USA

5. Pima County Health Department, Tucson, Arizona, USA

Abstract

Point-of-care antigen tests are an important tool for SARS-CoV-2 detection. Antigen tests are less sensitive than real-time reverse transcriptase PCR (rRT-PCR).

Funder

HHS | Centers for Disease Control and Prevention

Publisher

American Society for Microbiology

Subject

Microbiology (medical)

Reference37 articles.

1. U.S. Food and Drug Administration. 2021. In vitro diagnostics EUAs–antigen diagnostic tests for SARS-CoV-2. FDA Silver Spring MD. https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-antigen-diagnostic-tests-sars-cov-2.

2. Abbott Diagnostics. 2020. BinaxNOW COVID-19 Ag card (PN 195–000)—instructions for use. https://www.fda.gov/media/141570/download.

3. CMS. 2020. Updated CLIA SARS-CoV-2 molecular and antigen point of care test enforcement discretion. https://www.cms.gov/files/document/clia-sars-cov-2-point-care-test-enforcement-discretion.pdf.

4. U.S. Food and Drug Administration. 2020. COVID-19 test uses: FAQs on testing for SARS-CoV-2. FDA Silver Spring MD. https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/covid-19-test-uses-faqs-testing-sars-cov-2.

5. U.S. Department of Health and Human Services. 2020. Coronavirus (COVID-19) testing: expanding access to coronavirus (COVID-19) testing. https://www.hhs.gov/coronavirus/testing/index.html.

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