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

Genay Pilarowski; Paul Lebel; Sara Sunshine; Jamin Liu; Emily Crawford; Carina Marquez; Luis Rubio; Gabriel Chamie; Jackie Martinez; James Peng; Douglas Black; Wesley Wu; John Pak; Matthew T Laurie; Diane Jones; Steve Miller; Jon Jacobo; Susana Rojas; Susy Rojas; Robert Nakamura; Valerie Tulier-Laiwa; Maya Petersen; Diane V Havlir; - The CLIAHUB Consortium; Joseph DeRisi.
Preprint en Inglés | PREPRINT-MEDRXIV | ID: ppmedrxiv-20223891
We evaluated the performance of the Abbott BinaxNOW Covid-19 rapid antigen test to detect virus among persons, regardless of symptoms, at a public plaza site of ongoing community transmission. Titration with cultured clinical SARS-CoV-2 yielded a human observable threshold between 1.6x104-4.3x104 viral RNA copies (cycle threshold (Ct) of 30.3-28.8 in this assay). Among 878 subjects tested, 3% (26/878) were positive by RT-PCR, of which 15/26 had a 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 the 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%.