Nationwide quality assurance of high-throughput diagnostic molecular testing during the SARS-CoV-2 pandemic: role of the Belgian National Reference Centre.
[en] 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).
Disciplines :
Public health, health care sciences & services
Author, co-author :
Janssen, Reile; National Reference Centre for Respiratory Pathogens, Department of Laboratory Medicine, University Hospitals Leuven, 3000, Leuven, Belgium. reile.janssen@uzleuven.be
Cuypers, Lize; 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, Lies; 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, Els; 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, Kurt; National Reference Centre for Respiratory Pathogens, Department of Laboratory Medicine, University Hospitals Leuven, 3000, Leuven, Belgium
Janssenswillen, Sunita; Federal Testing Platform COVID-19, Department of Laboratory Medicine, University Hospitals Leuven, 3000, Leuven, Belgium
Slechten, Bram; Federal Testing Platform COVID-19, Department of Laboratory Medicine, University Hospitals Leuven, 3000, Leuven, Belgium
Bode, Jannes; National Reference Centre for Respiratory Pathogens, Department of Laboratory Medicine, University Hospitals Leuven, 3000, Leuven, Belgium
Wollants, Elke; Laboratory of Clinical and Epidemiological Virology, Department of Microbiology, Immunology and Transplantation, Rega Institute for Medical Research, KU Leuven, 3000, Leuven, Belgium
Van Laethem, Kristel; Laboratory of Clinical and Epidemiological Virology, Department of Microbiology, Immunology and Transplantation, Rega Institute for Medical Research, KU Leuven, 3000, Leuven, Belgium
Rector, Annabel; Laboratory of Clinical and Epidemiological Virology, Department of Microbiology, Immunology and Transplantation, Rega Institute for Medical Research, KU Leuven, 3000, Leuven, Belgium
Bloemen, Mandy; Laboratory of Clinical and Epidemiological Virology, Department of Microbiology, Immunology and Transplantation, Rega Institute for Medical Research, KU Leuven, 3000, Leuven, Belgium
Sijmons, Anke; National Reference Centre for Respiratory Pathogens, Department of Laboratory Medicine, University Hospitals Leuven, 3000, Leuven, Belgium
de Schaetzen, Nathalie; National Reference Centre for Respiratory Pathogens, Department of Laboratory Medicine, University Hospitals Leuven, 3000, Leuven, Belgium
Capron, Arnaud; Quality of Laboratories Unit, Scientific Directorate of Biological Health Risks, Sciensano, 1000, Brussels, Belgium
Van Baelen, Kurt; Janssen Pharmaceutica N.V, Johnson & Johnson, 2340, Beerse, Belgium
De Smet, Pieter; CliniSys|MIPS, 9000, Ghent, Belgium
Uten, Wouter; UgenTec N.V, 3500, Hasselt, Belgium
Malonne, Hugues; 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, Pierre; Federal Public Service Public Health, Safety of the Food Chain and the Environment, 1210, Brussels, Belgium
De Cock, Jo; National Institute for Health and Disability Insurance (RIZIV/INAMI), 1150, Brussels, Belgium
Matheeussen, Veerle; Federal Testing Platform COVID-19, University Hospitals Antwerp, 2650, Edegem, Belgium
Verhasselt, Bruno; Federal Testing Platform COVID-19, Department of Laboratory Medicine, Ghent University and Ghent University Hospital, 9000, Ghent, Belgium
Gillet, Laurent ; Université de Liège - ULiège > Département des maladies infectieuses et parasitaires (DMI) > Vaccinologie vétérinaire
Detry, Gautier; Federal Testing Platform COVID-19, Laboratory of Clinical Biology, Pole Hospitalier Jolimont, 7100, La Louvière, Belgium
Bearzatto, Bertrand; 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, Jonathan; Federal Testing Platform COVID-19, Department of Laboratory Medicine, CHU UCL Namur, 5530, Yvoir, Belgium
Henin, Coralie; Federal Testing Platform COVID-19, Université Libre de Bruxelles, 1070, Brussels, Belgium
Pairoux, Gregor; Quality of Laboratories Unit, Scientific Directorate of Biological Health Risks, Sciensano, 1000, Brussels, Belgium
COVID-19 Genomics Belgium Consortium
Maes, Piet; Laboratory of Clinical and Epidemiological Virology, Department of Microbiology, Immunology and Transplantation, Rega Institute for Medical Research, KU Leuven, 3000, Leuven, Belgium
Van Ranst, Marc; 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, Katrien; 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, Elisabeth; 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, Emmanuel; 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
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