Performance Characteristics of a Rapid Severe Acute Respiratory Syndrome Coronavirus 2 Antigen Detection Assay at a Public Plaza Testing Site in San Francisco

• Published in: The Journal of infectious diseases Vol. 223; no. 7; pp. 1139 - 1144
• Main Authors: Pilarowski, Genay, Lebel, Paul, Sunshine, Sara, Liu, Jamin, Crawford, Emily, Marquez, Carina, Rubio, Luis, Chamie, Gabriel, Martinez, Jackie, Peng, James, Black, Douglas, Wu, Wesley, Pak, John, Laurie, Matthew T, Jones, Diane, Miller, Steve, Jacobo, Jon, Rojas, Susana, Rojas, Susy, Nakamura, Robert, Tulier-Laiwa, Valerie, Petersen, Maya, Havlir, Diane V, DeRisi, Joseph
• Format: Journal Article
• Language: English
• Published: US Oxford University Press 08.04.2021
• Subjects: Adolescent; Adult; Antigens, Viral - isolation & purification; Asymptomatic Infections; Coronaviruses; COVID-19; COVID-19 - diagnosis; COVID-19 - transmission; COVID-19 - virology; COVID-19 Testing - instrumentation; COVID-19 Testing - statistics & numerical data; Female; Humans; Major and Brief Reports; Male; Middle Aged; Point-of-Care Testing - statistics & numerical data; Reagent Kits, Diagnostic - statistics & numerical data; RNA, Viral - isolation & purification; San Francisco; SARS-CoV-2 - genetics; SARS-CoV-2 - immunology; SARS-CoV-2 - isolation & purification; Sensitivity analysis; Sensitivity and Specificity; Severe acute respiratory syndrome coronavirus 2; Time Factors; Titration; Viral Load; Young Adult; San Francisco; COVID-19; Rapid Antigen Test; SARS-CoV-2; Point of Care testing
• ISSN: 0022-1899; 1537-6613; 1537-6613
• DOI: 10.1093/infdis/jiaa802

Abstract We evaluated the performance of the Abbott BinaxNOW rapid antigen test for coronavirus disease 2019 (Binax-CoV2) to detect virus among persons, regardless of symptoms, at a public plaza site of ongoing community transmission. Titration with cultured severe acute respiratory syndrome coronavirus 2 yielded a human observable threshold between 1.6 × 104-4.3 × 104 viral RNA copies (cycle threshold [Ct], 30.3–28.8). Among 878 subjects tested, 3% (26 of 878) were positive by reverse-transcription polymerase chain reaction, of whom 15 of 26 had a Ct <30, indicating high viral load; of these, 40% (6 of 15) were asymptomatic. Using this Ct threshold (<30) for Binax-CoV2 evaluation, the sensitivity of Binax-CoV2 was 93.3% (95% confidence interval, 68.1%–99.8%) (14 of 15) and the specificity was 99.9% (99.4%–99.9%) (855 of 856). This study examines the utility of the Abbott BinaxNOW rapid direct antigen severe acute respiratory syndrome coronavirus 2 in the context of community screening at a public transit hub, in comparison with reverse-transcription polymerase chain reaction.