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Comparative Diagnostic Utility of SARS-CoV-2 Rapid Antigen and Molecular Testing in a Community Setting.
Kim, Ashley E; Bennett, Julia C; Luiten, Kyle; O'Hanlon, Jessica A; Wolf, Caitlin R; Magedson, Ariana; Han, Peter D; Acker, Zack; Regelbrugge, Lani; McCaffrey, Kathryn M; Stone, Jeremey; Reinhart, David; Capodanno, Benjamin J; Morse, Stephen S; Bedford, Trevor; Englund, Janet A; Boeckh, Michael; Starita, Lea M; Uyeki, Timothy M; Carone, Marco; Weil, Ana; Chu, Helen Y.
Afiliación
  • Kim AE; Division of Allergy and Infectious Diseases, Department of Medicine, University of Washington, Seattle, Washington, USA.
  • Bennett JC; Department of Epidemiology, Mailman School of Public Health, Columbia University, New York, New York, USA.
  • Luiten K; Division of Allergy and Infectious Diseases, Department of Medicine, University of Washington, Seattle, Washington, USA.
  • O'Hanlon JA; Department of Epidemiology, University of Washington, Seattle, Washington, USA.
  • Wolf CR; Division of Allergy and Infectious Diseases, Department of Medicine, University of Washington, Seattle, Washington, USA.
  • Magedson A; Division of Allergy and Infectious Diseases, Department of Medicine, University of Washington, Seattle, Washington, USA.
  • Han PD; Division of Allergy and Infectious Diseases, Department of Medicine, University of Washington, Seattle, Washington, USA.
  • Acker Z; Division of Allergy and Infectious Diseases, Department of Medicine, University of Washington, Seattle, Washington, USA.
  • Regelbrugge L; Brotman Baty Institute for Precision Medicine, Seattle, Washington, USA.
  • McCaffrey KM; Department of Genome Sciences, University of Washington, Seattle, Washington, USA.
  • Stone J; Brotman Baty Institute for Precision Medicine, Seattle, Washington, USA.
  • Reinhart D; Department of Genome Sciences, University of Washington, Seattle, Washington, USA.
  • Capodanno BJ; Brotman Baty Institute for Precision Medicine, Seattle, Washington, USA.
  • Morse SS; Department of Genome Sciences, University of Washington, Seattle, Washington, USA.
  • Bedford T; Brotman Baty Institute for Precision Medicine, Seattle, Washington, USA.
  • Englund JA; Brotman Baty Institute for Precision Medicine, Seattle, Washington, USA.
  • Boeckh M; Department of Genome Sciences, University of Washington, Seattle, Washington, USA.
  • Starita LM; Brotman Baty Institute for Precision Medicine, Seattle, Washington, USA.
  • Uyeki TM; Department of Genome Sciences, University of Washington, Seattle, Washington, USA.
  • Carone M; Brotman Baty Institute for Precision Medicine, Seattle, Washington, USA.
  • Weil A; Department of Genome Sciences, University of Washington, Seattle, Washington, USA.
  • Chu HY; Department of Epidemiology, Mailman School of Public Health, Columbia University, New York, New York, USA.
J Infect Dis ; 230(2): 363-373, 2024 Aug 16.
Article en En | MEDLINE | ID: mdl-38531685
ABSTRACT

BACKGROUND:

SARS-CoV-2 antigen-detection rapid diagnostic tests (Ag-RDTs) have become widely utilized but longitudinal characterization of their community-based performance remains incompletely understood.

METHODS:

This prospective longitudinal study at a large public university in Seattle, WA utilized remote enrollment, online surveys, and self-collected nasal swab specimens to evaluate Ag-RDT performance against real-time reverse transcription polymerase chain reaction (rRT-PCR) in the context of SARS-CoV-2 Omicron. Ag-RDT sensitivity and specificity within 1 day of rRT-PCR were evaluated by symptom status throughout the illness episode and Orf1b cycle threshold (Ct).

RESULTS:

From February to December 2022, 5757 participants reported 17 572 Ag-RDT results and completed 12 674 rRT-PCR tests, of which 995 (7.9%) were rRT-PCR positive. Overall sensitivity and specificity were 53.0% (95% confidence interval [CI], 49.6%-56.4%) and 98.8% (95% CI, 98.5%-99.0%), respectively. Sensitivity was comparatively higher for Ag-RDTs used 1 day after rRT-PCR (69.0%), 4-7 days after symptom onset (70.1%), and Orf1b Ct ≤20 (82.7%). Serial Ag-RDT sensitivity increased with repeat testing ≥2 (68.5%) and ≥4 (75.8%) days after an initial Ag-RDT-negative result.

CONCLUSIONS:

Ag-RDT performance varied by clinical characteristics and temporal testing patterns. Our findings support recommendations for serial testing following an initial Ag-RDT-negative result, especially among recently symptomatic persons or those at high risk for SARS-CoV-2 infection.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Sensibilidad y Especificidad / Prueba Serológica para COVID-19 / SARS-CoV-2 / COVID-19 Límite: Adolescent / Adult / Aged / Female / Humans / Male / Middle aged País/Región como asunto: America do norte Idioma: En Revista: J Infect Dis Año: 2024 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Estados Unidos

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Sensibilidad y Especificidad / Prueba Serológica para COVID-19 / SARS-CoV-2 / COVID-19 Límite: Adolescent / Adult / Aged / Female / Humans / Male / Middle aged País/Región como asunto: America do norte Idioma: En Revista: J Infect Dis Año: 2024 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Estados Unidos