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Diagnostic accuracy of SARS-CoV-2 rapid antigen self-tests in asymptomatic individuals in the omicron period: a cross-sectional study.
Venekamp, Roderick P; Schuit, Ewoud; Hooft, Lotty; Veldhuijzen, Irene K; van den Bijllaardt, Wouter; Pas, Suzan D; Zwart, Vivian F; Lodder, Esther B; Hellwich, Marloes; Koppelman, Marco; Molenkamp, Richard; Wijers, Constantijn J H; Vroom, Irene H; Smeets, Leonard C; Nagel-Imming, Carla R S; Han, Wanda G H; van den Hof, Susan; Kluytmans, Jan A J W; van de Wijgert, Janneke H H M; Moons, Karel G M.
Afiliación
  • Venekamp RP; Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands.
  • Schuit E; Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands; Cochrane Netherlands, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands.
  • Hooft L; Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands; Cochrane Netherlands, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands.
  • Veldhuijzen IK; Centre for Infectious Disease Control, National Institute for Public Health and the Environment (RIVM), Bilthoven, the Netherlands.
  • van den Bijllaardt W; Microvida Laboratory for Medical Microbiology, Amphia Hospital, Breda, the Netherlands; Department of Infection Control, Amphia Hospital, Breda, the Netherlands.
  • Pas SD; Microvida Laboratory for Medical Microbiology, Amphia Hospital, Breda, the Netherlands; Microvida Laboratory for Medical Microbiology, Bravis Hospital, Roosendaal, the Netherlands.
  • Zwart VF; Microvida Laboratory for Medical Microbiology, Amphia Hospital, Breda, the Netherlands.
  • Lodder EB; Public Health Service West-Brabant, Breda, the Netherlands.
  • Hellwich M; Public Health Service Hart voor Brabant, Tilburg, the Netherlands.
  • Koppelman M; National Screening Laboratory of Sanquin, Sanquin Blood Supply Foundation, Amsterdam, the Netherlands.
  • Molenkamp R; Department of Viroscience, Erasmus MC, Rotterdam, the Netherlands.
  • Wijers CJH; Public Health Service Rotterdam-Rijnmond, Rotterdam, the Netherlands.
  • Vroom IH; Public Health Service Rotterdam-Rijnmond, Rotterdam, the Netherlands.
  • Smeets LC; Reinier Haga Medical Diagnostic Center, Delft, the Netherlands.
  • Nagel-Imming CRS; Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands.
  • Han WGH; Centre for Infectious Disease Control, National Institute for Public Health and the Environment (RIVM), Bilthoven, the Netherlands.
  • van den Hof S; Centre for Infectious Disease Control, National Institute for Public Health and the Environment (RIVM), Bilthoven, the Netherlands.
  • Kluytmans JAJW; Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands.
  • van de Wijgert JHHM; Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands.
  • Moons KGM; Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands; Cochrane Netherlands, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands. Electronic address: k.g.m.moons@umcutrecht.nl.
Clin Microbiol Infect ; 29(3): 391.e1-391.e7, 2023 Mar.
Article en En | MEDLINE | ID: mdl-36379401
OBJECTIVES: To assess the performances of three commonly used antigen rapid diagnostic tests used as self-tests in asymptomatic individuals in the Omicron period. METHODS: We performed a cross-sectional diagnostic test accuracy study in the Omicron period in three public health service COVID-19 test sites in the Netherlands, including 3600 asymptomatic individuals aged ≥ 16 years presenting for SARS-CoV-2 testing for any reason except confirmatory testing after a positive self-test. Participants were sampled for RT-PCR (reference test) and received one self-test (either Acon Flowflex [Flowflex], MP Biomedicals (MPBio), or Siemens-Healthineers CLINITEST [CLINITEST]) to perform unsupervised at home. Diagnostic accuracies of each self-test were calculated. RESULTS: Overall sensitivities were 27.5% (95% CI, 21.3-34.3%) for Flowflex, 20.9% (13.9-29.4%) for MPBio, and 25.6% (19.1-33.1%) for CLINITEST. After applying a viral load cut-off (≥5.2 log10 SARS-CoV-2 E-gene copies/mL), sensitivities increased to 48.3% (37.6-59.2%), 37.8% (22.5-55.2%), and 40.0% (29.5-51.2%), respectively. Specificities were >99% for all tests in most analyses. DISCUSSION: The sensitivities of three commonly used SARS-CoV-2 antigen rapid diagnostic tests when used as self-tests in asymptomatic individuals in the Omicron period were very low. Antigen rapid diagnostic test self-testing in asymptomatic individuals may only detect a minority of infections at that point in time. Repeated self-testing in case of a negative self-test is advocated to improve the diagnostic yield, and individuals should be advised to re-test when symptoms develop.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: COVID-19 Tipo de estudio: Diagnostic_studies / Observational_studies / Prevalence_studies Límite: Humans País/Región como asunto: Europa Idioma: En Revista: Clin Microbiol Infect Asunto de la revista: DOENCAS TRANSMISSIVEIS / MICROBIOLOGIA Año: 2023 Tipo del documento: Article País de afiliación: Países Bajos Pais de publicación: Reino Unido
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: COVID-19 Tipo de estudio: Diagnostic_studies / Observational_studies / Prevalence_studies Límite: Humans País/Región como asunto: Europa Idioma: En Revista: Clin Microbiol Infect Asunto de la revista: DOENCAS TRANSMISSIVEIS / MICROBIOLOGIA Año: 2023 Tipo del documento: Article País de afiliación: Países Bajos Pais de publicación: Reino Unido