학술논문

Nationwide quality assurance of high-throughput diagnostic molecular testing during the SARS-CoV-2 pandemic: role of the Belgian National Reference Centre.
Document Type
Academic Journal
Author
Janssen R; National Reference Centre for Respiratory Pathogens, Department of Laboratory Medicine, University Hospitals Leuven, 3000, Leuven, Belgium. reile.janssen@uzleuven.be.; Cuypers L; National Reference Centre for Respiratory Pathogens, Department of Laboratory Medicine, University Hospitals Leuven, 3000, Leuven, Belgium.; Laboratory of Clinical Microbiology, Department of Microbiology, Immunology and Transplantation, KU Leuven, 3000, Leuven, Belgium.; Laenen L; National Reference Centre for Respiratory Pathogens, Department of Laboratory Medicine, University Hospitals Leuven, 3000, Leuven, Belgium.; Laboratory of Clinical Microbiology, Department of Microbiology, Immunology and Transplantation, KU Leuven, 3000, Leuven, Belgium.; Keyaerts E; National Reference Centre for Respiratory Pathogens, Department of Laboratory Medicine, University Hospitals Leuven, 3000, Leuven, Belgium.; Laboratory of Clinical Microbiology, Department of Microbiology, Immunology and Transplantation, KU Leuven, 3000, Leuven, Belgium.; Beuselinck K; National Reference Centre for Respiratory Pathogens, Department of Laboratory Medicine, University Hospitals Leuven, 3000, Leuven, Belgium.; Janssenswillen S; Federal Testing Platform COVID-19, Department of Laboratory Medicine, University Hospitals Leuven, 3000, Leuven, Belgium.; Slechten B; Federal Testing Platform COVID-19, Department of Laboratory Medicine, University Hospitals Leuven, 3000, Leuven, Belgium.; Bode J; National Reference Centre for Respiratory Pathogens, Department of Laboratory Medicine, University Hospitals Leuven, 3000, Leuven, Belgium.; Wollants E; Laboratory of Clinical and Epidemiological Virology, Department of Microbiology, Immunology and Transplantation, Rega Institute for Medical Research, KU Leuven, 3000, Leuven, Belgium.; Van Laethem K; Laboratory of Clinical and Epidemiological Virology, Department of Microbiology, Immunology and Transplantation, Rega Institute for Medical Research, KU Leuven, 3000, Leuven, Belgium.; Rector A; Laboratory of Clinical and Epidemiological Virology, Department of Microbiology, Immunology and Transplantation, Rega Institute for Medical Research, KU Leuven, 3000, Leuven, Belgium.; Bloemen M; Laboratory of Clinical and Epidemiological Virology, Department of Microbiology, Immunology and Transplantation, Rega Institute for Medical Research, KU Leuven, 3000, Leuven, Belgium.; Sijmons A; National Reference Centre for Respiratory Pathogens, Department of Laboratory Medicine, University Hospitals Leuven, 3000, Leuven, Belgium.; de Schaetzen N; National Reference Centre for Respiratory Pathogens, Department of Laboratory Medicine, University Hospitals Leuven, 3000, Leuven, Belgium.; Capron A; Quality of Laboratories Unit, Scientific Directorate of Biological Health Risks, Sciensano, 1000, Brussels, Belgium.; Van Baelen K; Janssen Pharmaceutica N.V, Johnson & Johnson, 2340, Beerse, Belgium.; Pascal T; GSK Vaccines, 1330, Rixensart, Belgium.; Vermeiren C; UCB Pharma, 1420, Braine L'Alleud, Belgium.; Bureau F; Laboratory of Cellular and Molecular Immunology, GIGA Institute, University of Liège, 4000, Liège, Belgium.; Vandesompele J; Biogazelle, a CellCarta Company, Technologiepark Zwijnaarde, 9052, Zwijnaarde, Belgium.; De Smet P; CliniSys|MIPS, 9000, Ghent, Belgium.; Uten W; UgenTec N.V, 3500, Hasselt, Belgium.; Malonne H; Federal Agency for Medicines and Health Products (FAGG-AFMPS), 1210, Brussels, Belgium.; Department of Pharmacology, Pharmacotherapy and Pharmaceutical Care, Faculty of Pharmacy, Université Libre de Bruxelles, 1070, Brussels, Belgium.; Department of Biomedical Sciences, Namur Research Institute for Life Sciences, University of Namur, 5000, Namur, Belgium.; Kerkhofs P; Federal Public Service Public Health, Safety of the Food Chain and the Environment, 1210, Brussels, Belgium.; De Cock J; National Institute for Health and Disability Insurance (RIZIV/INAMI), 1150, Brussels, Belgium.; Matheeussen V; Federal Testing Platform COVID-19, University Hospitals Antwerp, 2650, Edegem, Belgium.; Verhasselt B; Federal Testing Platform COVID-19, Department of Laboratory Medicine, Ghent University and Ghent University Hospital, 9000, Ghent, Belgium.; Gillet L; Federal Testing Platform COVID-19, University of Liège, 4000, Liège, Belgium.; Detry G; Federal Testing Platform COVID-19, Laboratory of Clinical Biology, Pole Hospitalier Jolimont, 7100, La Louvière, Belgium.; Bearzatto B; Federal Testing Platform COVID-19, Centre Des Technologies Moléculaires Appliquées (CTMA), Institute of Experimental and Clinical Research (IREC), Cliniques Universitaires Saint-Luc and Université Catholique de Louvain (UCLouvain), 1200, Brussels, Belgium.; Degosserie J; Federal Testing Platform COVID-19, Department of Laboratory Medicine, CHU UCL Namur, 5530, Yvoir, Belgium.; Henin C; Federal Testing Platform COVID-19, Université Libre de Bruxelles, 1070, Brussels, Belgium.; Pairoux G; Quality of Laboratories Unit, Scientific Directorate of Biological Health Risks, Sciensano, 1000, Brussels, Belgium.; Maes P; Laboratory of Clinical and Epidemiological Virology, Department of Microbiology, Immunology and Transplantation, Rega Institute for Medical Research, KU Leuven, 3000, Leuven, Belgium.; Van Ranst M; National Reference Centre for Respiratory Pathogens, Department of Laboratory Medicine, University Hospitals Leuven, 3000, Leuven, Belgium.; Laboratory of Clinical and Epidemiological Virology, Department of Microbiology, Immunology and Transplantation, Rega Institute for Medical Research, KU Leuven, 3000, Leuven, Belgium.; Lagrou K; National Reference Centre for Respiratory Pathogens, Department of Laboratory Medicine, University Hospitals Leuven, 3000, Leuven, Belgium.; Laboratory of Clinical Microbiology, Department of Microbiology, Immunology and Transplantation, KU Leuven, 3000, Leuven, Belgium.; Dequeker E; National Reference Centre for Respiratory Pathogens, Department of Laboratory Medicine, University Hospitals Leuven, 3000, Leuven, Belgium.; Biomedical Quality Assurance Research Unit, Department of Public Health and Primary Care, University of Leuven, 3000, Leuven, Belgium.; André E; National Reference Centre for Respiratory Pathogens, Department of Laboratory Medicine, University Hospitals Leuven, 3000, Leuven, Belgium.; Laboratory of Clinical Microbiology, Department of Microbiology, Immunology and Transplantation, KU Leuven, 3000, Leuven, Belgium.
Source
Publisher: BioMed Central Country of Publication: England NLM ID: 101231645 Publication Model: Electronic Cited Medium: Internet ISSN: 1743-422X (Electronic) Linking ISSN: 1743422X NLM ISO Abbreviation: Virol J Subsets: MEDLINE
Subject
Language
English
Abstract
Since the onset of the coronavirus disease (COVID-19) pandemic in Belgium, UZ/KU Leuven has played a crucial role as the National Reference Centre (NRC) for respiratory pathogens, to be the first Belgian laboratory to develop and implement laboratory developed diagnostic assays for SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) and later to assess the quality of commercial kits. To meet the growing demand for decentralised testing, both clinical laboratories and government-supported high-throughput platforms were gradually deployed across Belgium. Consequently, the role of the NRC transitioned from a specialised testing laboratory to strengthening capacity and coordinating quality assurance. Here, we outline the measures taken by the NRC, the national public health institute Sciensano and the executing clinical laboratories to ensure effective quality management of molecular testing throughout the initial two years of the pandemic (March 2020 to March 2022).
(© 2024. The Author(s).)