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Rapid antigen testing for SARS-CoV-2 by lateral flow assay: A field evaluation of self- and professional testing at UK community testing sites.
Futschik, Matthias E; Johnson, Samuel; Turek, Elena; Chapman, David; Carr, Simon; Thorlu-Bangura, Zareen; Klapper, Paul E; Sudhanva, Malur; Dodgson, Andrew; Cole-Hamilton, Joanna R; Germanacos, Nick; Kulasegaran-Shylini, Raghavendran; Blandford, Edward; Tunkel, Sarah; Peto, Timothy; Hopkins, Susan; Fowler, Tom.
Afiliación
  • Futschik ME; UK Health Security Agency, London, United Kingdom; University of Plymouth, School of Biomedical Sciences, Faculty of Health, Plymouth, United Kingdom.
  • Johnson S; University of Manchester, Manchester, United Kingdom.
  • Turek E; Deloitte, London, United Kingdom, Deloitte MCS Ltd, London, United Kingdom.
  • Chapman D; Deloitte, London, United Kingdom, Deloitte MCS Ltd, London, United Kingdom.
  • Carr S; Deloitte, London, United Kingdom, Deloitte MCS Ltd, London, United Kingdom.
  • Thorlu-Bangura Z; UK Health Security Agency, London, United Kingdom.
  • Klapper PE; UK Health Security Agency, London, United Kingdom; University of Manchester, Manchester, United Kingdom.
  • Sudhanva M; UK Health Security Agency, London, United Kingdom; King's College Hospital NHS Foundation Trust, London, UK.
  • Dodgson A; UK Health Security Agency, London, United Kingdom; University of Manchester, Manchester, United Kingdom.
  • Cole-Hamilton JR; UK Health Security Agency, London, United Kingdom.
  • Germanacos N; UK Health Security Agency, London, United Kingdom.
  • Kulasegaran-Shylini R; UK Health Security Agency, London, United Kingdom.
  • Blandford E; UK Health Security Agency, London, United Kingdom.
  • Tunkel S; UK Health Security Agency, London, United Kingdom.
  • Peto T; University of Oxford, Oxford, United Kingdom.
  • Hopkins S; UK Health Security Agency, London, United Kingdom.
  • Fowler T; UK Health Security Agency, London, United Kingdom; Queen Mary University of London, William Harvey Research Institute, London, United Kingdom. Electronic address: Tom.Fowler2@ukhsa.gov.uk.
J Clin Virol ; 171: 105654, 2024 04.
Article en En | MEDLINE | ID: mdl-38387136
ABSTRACT

BACKGROUND:

The advent of lateral flow devices (LFDs) for SARS-CoV-2 detection enabled widespread use of rapid self-tests during the pandemic. While self-testing using LFDs is now common, whether self-testing provides comparable performance to professional testing was a key question that remained important for pandemic planning.

METHODS:

Three prospective multi-centre studies were conducted to compare the performance of self- and professional testing using LFDs. Participants tested themselves or were tested by trained (professional) testers at community testing sites in the UK. Corresponding qRT-PCR test results served as reference standard. The performance of Innova, Orient Gene and SureScreen LFDs by users (self) and professional testers was assessed in terms of sensitivity, specificity, and kit failure (void) rates. Impact of age, sex and symptom status was analysed using logistic regression modelling.

RESULTS:

16,617 participants provided paired tests, of which 15,418 were included in the analysis. Self-testing with Innova, Orient Gene or SureScreen LFDs achieved sensitivities of 50 %, 53 % or 72 %, respectively, compared to qRT-PCR. Self and professional LFD testing showed no statistically different sensitivity with respect to corresponding qRT-PCR testing. Specificity was consistently equal to or higher than 99 %. Sex and age had no or only marginal impact on LFD performance while sensitivity was significantly higher for symptomatic individuals. Sensitivity of LFDs increased strongly to up to 90 % with higher levels of viral RNA measured by qRT-PCR.

CONCLUSIONS:

Our results support SARS-CoV-2 self-testing with LFDs, especially for the detection of individuals whose qRT-PCR tests showed high viral concentrations.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: COVID-19 Límite: Humans País/Región como asunto: Europa Idioma: En Revista: J Clin Virol Asunto de la revista: VIROLOGIA Año: 2024 Tipo del documento: Article País de afiliación: Reino Unido Pais de publicación: Países Bajos
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: COVID-19 Límite: Humans País/Región como asunto: Europa Idioma: En Revista: J Clin Virol Asunto de la revista: VIROLOGIA Año: 2024 Tipo del documento: Article País de afiliación: Reino Unido Pais de publicación: Países Bajos