Diagnostic accuracy of a point-of-care antigen test for SARS-CoV-2 and influenza in a primary care population (RAPTOR-C19).

Autor:	Fanshawe TR; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK. Electronic address: thomas.fanshawe@phc.ox.ac.uk., Tonner S; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK., Turner PJ; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK., Cogdale J; Virus Reference Department, Respiratory Virus Unit, UK Health Security Agency, UK., Glogowska M; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK., de Lusignan S; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK., Okusi C; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK., Perera R; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK., Sebastianpillai P; Immunization and Vaccine Preventable Diseases Division and Public Health Programmes, UK Health Security Agency, UK., Williams A; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK., Zambon M; Influenza and Respiratory Virology and Polio Reference Service, UK Health Security Agency, UK; NIHR Health Protection Research Unit, Imperial College London, UK., Nicholson BD; Virus Reference Department, Respiratory Virus Unit, UK Health Security Agency, UK., Hobbs FDR; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK; Virus Reference Department, Respiratory Virus Unit, UK Health Security Agency, UK., Hayward GN; Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK; Virus Reference Department, Respiratory Virus Unit, UK Health Security Agency, UK.
Jazyk:	angličtina
Zdroj:	Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases [Clin Microbiol Infect] 2024 Mar; Vol. 30 (3), pp. 380-386. Date of Electronic Publication: 2023 Dec 15.
DOI:	10.1016/j.cmi.2023.12.009
Abstrakt:	Objectives: Limited evidence exists for the diagnostic performance of point-of-care tests for SARS-CoV-2 and influenza in community healthcare. We carried out a prospective diagnostic accuracy study of the LumiraDx™ SARS-CoV-2 and influenza A or B assay in primary care. Methods: Total of 913 adults and children with symptoms of current SARS-CoV-2 infection were recruited from 18 UK primary care practices during a period when Omicron was the predominant COVID variant of concern (June 2022 to December 2022). Trained health care staff performed the index test, with diagnostic accuracy parameters estimated for SARS-CoV-2 and influenza against real-time reverse-transcription PCR (rtRT-PCR). Results: 151/887 participants were SARS-CoV-2 rtRT-PCR positive, 109 positive for Influenza A, 6 for Influenza B. Index test sensitivity for SARS-CoV-2 was 80.8% (122 of the 151, 95% CI, 73.6-86.7%) and specificity 98.9% (728 of the 736, 95% CI, 97.9-99.5%). For influenza A, sensitivity was 61.5% (67 of the 109, 95% CI, 51.7-70.6%) and specificity 99.4% (771 of the 776, 95% CI, 98.5-99.8%). Sensitivity to detect SARS-CoV-2 and influenza dropped sharply at rtRT-PCR cycle thresholds (Ct) > 30. Discussions: The LumiraDx™ SARS-CoV-2 and influenza A/B assay had moderate sensitivity for SARS-CoV-2 in symptomatic patients in primary care, with lower performance with high rtRT-PCR Ct. Negative results in this patient group cannot definitively rule out SARS-CoV-2 or influenza. (Copyright © 2023 The Authors. Published by Elsevier Ltd.. All rights reserved.)
Databáze:	MEDLINE
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