Implementation and Accuracy of BinaxNOW Rapid Antigen COVID-19 Test in Asymptomatic and Symptomatic Populations in a High-Volume Self-Referred Testing Site

Author:

Siddiqui Zishan K.1ORCID,Chaudhary Mihir2,Robinson Matthew L.1,McCall Anna B.3,Peralta Ria3,Esteve Rogette3,Callahan Charles W.4,Manabe Yukari C.1,Campbell James D.5,Johnson J. Kristie6,Elhabashy Maryam7,Kantsiper Melinda8,Ficke James R.9,

Affiliation:

1. Department of Medicine, The Johns Hopkins University School of Medicine, Baltimore, Maryland, USA

2. Department of Surgery, University of California-East Bay, Oakland, California, USA

3. Baltimore Convention Center Field Hospital, Baltimore, Maryland, USA

4. Population Health, University of Maryland Medical System, Baltimore, Maryland, USA

5. Center for Vaccine Development and Global Health, Department of Pediatrics, University of Maryland School of Medicine, Baltimore, Maryland, USA

6. Department of Pathology, University of Maryland School of Medicine, Baltimore, Maryland, USA

7. University of Maryland Baltimore County, Catonsville, Maryland, USA

8. Division of Hospital Medicine, The Johns Hopkins Bayview Medical Center, Baltimore, Maryland, USA

9. Department of Orthopedic Surgery, The Johns Hopkins University, Baltimore, Maryland, USA

Abstract

The BinaxNOW rapid antigen COVID-19 test had a sensitivity of 87% in symptomatic and 71% asymptomatic individuals when performed by health care workers in a high-throughput setting. The performance may expedite isolation decisions or referrals for time-sensitive monoclonal antibody treatment in communities where timely COVID PCR tests are unavailable.

Publisher

American Society for Microbiology

Subject

Infectious Diseases,Cell Biology,Microbiology (medical),Genetics,General Immunology and Microbiology,Ecology,Physiology

Reference18 articles.

1. U.S. Department of Health & Human Services. 2021. Biden administration announces actions to expand COVID-19 testing. Press release. February 17 2021. https://www.hhs.gov/about/news/2021/02/17/biden-administration-announces-actions-expand-covid-19-testing.html. Accessed on March 29.

2. An Overview of Nucleic Acid Testing for the Novel Coronavirus SARS-CoV-2

3. Lazer D Santillana M Perlis RH Ognyanova K Baum MA. 2021. State of the nation: a 50-state COVID-19 survey: Report #8: failing the test: waiting times for COVID diagnostic tests across the U.S. August 2020. https://covidstates.net/COVID19%20CONSORTIUM%20REPORT%208%20TEST%20JULY%202020.pdf. Accessed on May 13.

4. Hinton DM. 2021. BinaxNOW COVID-19 ag card home test letter of authorization. April 12 2021. U.S. Food and Drug Administration. https://www.fda.gov/media/144576/download. Accessed on April 23.

5. U.S. Food & Drug Administration. 2021. Coronavirus disease 2019 (COVID-19) emergency use authorizations for medical devices: in vitro diagnostics EUAs. https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas. Accessed on March 29.

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