Performance characteristics of a rapid SARS-CoV-2 antigen detection assay at a public plaza testing site in San Francisco

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Abstract

We evaluated the performance of the Abbott BinaxNOW ^TM Covid-19 rapid antigen test (Binax-CoV2) to detect virus among persons, regardless of symptoms, at a public plaza site of ongoing community transmission. Titration with cultured SARS-CoV-2 yielded a human observable threshold between 1.6x10 ⁴-4.3x10 ⁴ viral RNA copies (cycle threshold (Ct) of 30.3-28.8). Among 878 subjects tested, 3% (26/878) were positive by RT-PCR, of which 15/26 had Ct<30, indicating high viral load. 40% (6/15) of Ct<30 were asymptomatic. Using this Ct<30 threshold for Binax-CoV2 evaluation, the sensitivity of Binax-CoV2 was 93.3% (14/15), 95% CI: 68.1-99.8%, and the specificity was 99.9% (855/856), 95% CI: 99.4-99.9%.

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Author and article information

Journal

Journal ID (nlm-ta): J Infect Dis

Journal ID (iso-abbrev): J Infect Dis

Journal ID (publisher-id): jid

Title: The Journal of Infectious Diseases

Publisher: Oxford University Press (US )

ISSN (Print): 0022-1899

ISSN (Electronic): 1537-6613

Publication date (Electronic): 04 January 2021

Electronic Location Identifier: jiaa802

Affiliations

[1 ] Department of Pathology, Stanford University, Stanford , CA, USA

[2 ] Chan Zuckerberg Biohub, San Francisco , CA, USA

[3 ] Department of Biochemistry and Biophysics, University of California San Francisco , CA, USA

[4 ] Department of Microbiology and Immunology , University of California San Francisco, CA

[5 ] Division of HIV, Infectious Diseases, and Global Medicine , University of California, San Francisco, San Francisco, CA, USA

[6 ] Unidos en Salud, San Francisco , CA, USA

[7 ] Department of Laboratory Medicine , University of California San Francisco CA, USA

[8 ] Latino Task Force-COVID-19, San Francisco , CA, USA

[9 ] California Department of Public Health, Microbial Diseases Laboratory , Richmond, CA, USA

[10 ] Division of Epidemiology and Biostatistics, University of California, Berkeley , Berkeley, CA, USA

Author notes

Corresponding author: Joseph DeRisi, 1700 4 ^th St., San Francisco, CA 94158, USA, Phone: 415-418-3647, Email: joe@ 123456derisilab.ucsf.edu

Alternate corresponding author: Genay Pilarowski, 3373 Hillview Avenue, Rm 260, Palo Alto, CA 94304, USA, Phone: 707-498-6177, Email: genay@ 123456stanford.edu

Author information

Gabriel Chamie http://orcid.org/0000-0002-5860-8081

Article

Publisher ID: jiaa802

DOI: 10.1093/infdis/jiaa802

PMC ID: 7799021

PubMed ID: 33394052

SO-VID: 34e74b85-8bbb-44f4-8d68-34011eed5564

License:

This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs licence ( http://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial reproduction and distribution of the work, in any medium, provided the original work is not altered or transformed in any way, and that the work is properly cited. For commercial re-use, please contact journals.permissions@oup.com