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Diagnostic accuracy of a point-of-care antigen test for SARS-CoV-2 and influenza in a primary care population (RAPTOR-C19).
Fanshawe, Thomas R; Tonner, Sharon; Turner, Philip J; Cogdale, Jade; Glogowska, Margaret; de Lusignan, Simon; Okusi, Cecilia; Perera, Rafael; Sebastianpillai, Praveen; Williams, Alice; Zambon, Maria; Nicholson, Brian D; Hobbs, F D Richard; Hayward, Gail N.
Afiliação
  • 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.
Clin Microbiol Infect ; 30(3): 380-386, 2024 Mar.
Article em En | MEDLINE | ID: mdl-38103638
ABSTRACT

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.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Aves Predatórias / Influenza Humana / COVID-19 Limite: Adult / Animals / Child / Humans Idioma: En Revista: Clin Microbiol Infect Assunto da revista: DOENCAS TRANSMISSIVEIS / MICROBIOLOGIA Ano de publicação: 2024 Tipo de documento: Article

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Aves Predatórias / Influenza Humana / COVID-19 Limite: Adult / Animals / Child / Humans Idioma: En Revista: Clin Microbiol Infect Assunto da revista: DOENCAS TRANSMISSIVEIS / MICROBIOLOGIA Ano de publicação: 2024 Tipo de documento: Article