Performance Characteristics of BinaxNOW COVID-19 Antigen Card for Screening Asymptomatic Individuals in a University Setting

Author:

Okoye Nkemakonam C.1,Barker Adam P.23,Curtis Kenneth4,Orlandi Richard R.5,Snavely Emily A.1,Wright Cameron6,Hanson Kimberly E.237ORCID,Pearson Lauren N.13ORCID

Affiliation:

1. Department of Pathology, University of Utah School of Medicine, Salt Lake City, Utah, USA

2. Department of Pathology, Section of Clinical Microbiology, University of Utah School of Medicine, Salt Lake City, Utah, USA

3. ARUP Laboratories Institute for Clinical and Experimental Pathology, Salt Lake City, Utah, USA

4. ARUP Laboratories, Salt Lake City, Utah, USA

5. Department of Surgery, Division of Otolaryngology—Head and Neck Surgery, University of Utah School of Medicine, Salt Lake City, Utah, USA

6. University of Utah Medical Group, Salt Lake City, Utah, USA

7. Department of Medicine, Division of Infectious Diseases, University of Utah School of Medicine, Salt Lake City, Utah, USA

Abstract

We compared the performance of the Abbott BinaxNOW COVID-19 antigen card to that of a standard reverse transcription-PCR (RT-PCR) assay (Thermo Fisher TaqPath COVID-19 Combo kit) for the detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in 2,645 asymptomatic students presenting for screening at the University of Utah. SARS-CoV-2 RNA was detected in 1.7% of the study participants by RT-PCR.

Funder

ARUP Institute for Clinical and Experimental Pathology

Publisher

American Society for Microbiology

Subject

Microbiology (medical)

Reference23 articles.

1. Rapid, point-of-care antigen and molecular-based tests for diagnosis of SARS-CoV-2 infection

2. US Food and Drug Administration. 22 December 2020, accession date. Individual EUAs for antigen diagnostic tests for SARS-CoV-2. US Food and Drug Administration, Silver Spring, MD. https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/vitro-diagnostics-euas#individual-antigen.

3. US Department of Health and Human Services. 2020. Guidance for PREP Act coverage for COVID-19 screening tests at nursing homes, assisted-living facilities, long-term-care facilities, and other congregate facilities. US Department of Health and Human Services, Washington, DC. https://www.hhs.gov/guidance/sites/default/files/hhs-guidance-documents//prep-act-coverage-for-screening-in-congregate-settings.pdf. Accessed 19 December 2020.

4. Abbott Diagnostics Scarborough, Inc. 2020. BinaxNOW COVID-19 Ag card product insert. Abbott Diagnostics Scarborough, Inc, Scarborough, ME.

5. US Department of Health and Human Services. 2020. Trump administration will deploy 150 million rapid tests in 2020. US Department of Health and Human Services, Washington, DC. https://www.hhs.gov/about/news/2020/08/27/trump-administration-will-deploy-150-million-rapid-tests-in-2020.html. Accessed 19 December 2020.

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