A European multicentre evaluation of detection and typing methods for human enteroviruses and parechoviruses using RNA transcripts
Hayes, A. (University of Oxford)
Nguyen, D. (University of Oxford)
Andersson, M. (John Radcliffe Hospital (Oxford, Regne Unit))
Antón, Andrés (Hospital Universitari Vall d'Hebron. Institut de Recerca)
Bailly, Jean-Luc (Université Clermont Auvergne)
Beard, S. (National Infection Service, Public Health England)
Benschop, Kimberley S. M (National Institute for Public Health and the Environment (RIVM), The Netherlands.)
Berginc, N. (National Laboratory of Health, Environment and Food, Ljubljana, Slovenia.)
Blomqvist, S. (National Institute for Health and Welfare, Finland.)
Cunningham, E. (St. Thomas' Hospital, London, UK.)
Davis, D. (Great Ormond Street Hospital for Children (Londres))
Dembinski, J. L. (Norwegian Institute of Public Health)
Diedrich, S. (Robert Koch Institute, Berlin, Germany.)
Dudman, Susanne (University of Oslo)
Dyrdak, R. (Karolinska University Hospital and Karolinska Institutet (Suècia))
Eltringham, G. J. A. (Freeman Hospital, Newcastle Upon Tyne, UK.)
Gonzales-Goggia, S. (National Infection Service, Public Health England)
Gunson, R. (Glasgow Royal Infirmary)
Howson-Wells, H. C. (Nottingham University Hospitals NHS Trust (Regne Unit))
Jääskeläinen, A. J. (Helsinki University Hospital (Finlàndia))
López-Labrador, F. X. (Fundació per al Foment de la Investigació Sanitària i Biomèdica de la Comunitat Valenciana (Fisabio))
Maier, M. (Leipzig University Hospital)
Majumdar, M. (The National Institute for Biological Standards and Control, Hertfordshire, UK.)
Midgley, S. (Statens Serum Institut, Copenhagen, Denmark.)
Mirand, A. (CHU Clermont-Ferrand)
Morley, U. (University College Dublin)
Nordbø, S. A. (St Olav's University Hospital)
Oikarinen, S. (Tampere University, Finland.)
Osman, H. (Heartlands Hospital, Birmingham, UK.)
Papa, A. (Aristotle University of Thessaloniki)
Pellegrinelli, L. (University of Milan)
Piralla, A. (Fondazione IRCCS Policlinico San Matteo, Pavia.)
Rabella, Núria (Institut d'Investigació Biomèdica Sant Pau)
Richter, Jan (Cyprus Institute of Neurology and Genetics)
Smith, M. (King's College Hospital NHS Foundation Trust)
Söderlund Strand, A. (Lund University Hospital, Sweden.)
Templeton, K. (Royal Infirmary of Edinburgh)
Vipond, B. (Southmead Hospital, Bristol, UK.)
Vuorinen, T. (Turku University Hospital (Finlàndia))
Williams, C. (Royal Oldham Hospital, UK.)
Wollants, E. (REGA Institute, Leuven, Belgium.)
Zakikhany, K. (Katherina Zakikhany-Gilg, Public Health Agency of Sweden)
Fischer, T. K. (Statens Serum Institut, Copenhagen, Denmark.)
Harvala, H. (NHS Blood and Transplant, UK.)
Simmonds, Peter (University of Oxford)
Universitat Autònoma de Barcelona

Data:	2020
Resum:	Polymerase chain reaction (PCR) detection has become the gold standard for diagnosis and typing of enterovirus (EV) and human parechovirus (HPeV) infections. Its effectiveness depends critically on using the appropriate sample types and high assay sensitivity as viral loads in cerebrospinal fluid samples from meningitis and sepsis clinical presentation can be extremely low. This study evaluated the sensitivity and specificity of currently used commercial and in-house diagnostic and typing assays. Accurately quantified RNA transcript controls were distributed to 27 diagnostic and 12 reference laboratories in 17 European countries for blinded testing. Transcripts represented the four human EV species (EV-A71, echovirus 30, coxsackie A virus 21, and EV-D68), HPeV3, and specificity controls. Reported results from 48 in-house and 15 commercial assays showed 98% detection frequencies of high copy (1000 RNA copies/5 µL) transcripts. In-house assays showed significantly greater detection frequencies of the low copy (10 copies/5 µL) EV and HPeV transcripts (81% and 86%, respectively) compared with commercial assays (56%, 50%; P = 7 × 10 −5). EV-specific PCRs showed low cross-reactivity with human rhinovirus C (3 of 42 tests) and infrequent positivity in the negative control (2 of 63 tests). Most or all high copy EV and HPeV controls were successfully typed (88%, 100%) by reference laboratories, but showed reduced effectiveness for low copy controls (41%, 67%). Stabilized RNA transcripts provide an effective, logistically simple and inexpensive reagent for evaluation of diagnostic assay performance. The study provides reassurance of the performance of the many in-house assay formats used across Europe. However, it identified often substantially reduced sensitivities of commercial assays often used as point-of-care tests.
Ajuts:	European Commission 643476
Nota:	Altres ajuts: The work in Oxford was funded in part by a Wellcome ISSF grant (ISSF204826/Z/16/Z). [...] financial support was provided by CIBEResp, Instituto de Salud Carlos III, Spain.
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Matèria:	Enterovirus ; Enterovirus A71 ; Parechovirus ; PCR ; RNA transcripts
Publicat a:	Journal of Medical Virology, Vol. 92 (january 2020) , p. 1065-1074, ISSN 1096-9071

DOI: 10.1002/jmv.25659
PMID: 31883139

10 p, 2.2 MB

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