首页> Clinical chemistry and laboratory medicine> ISO 15189 is a sufficient instrument to guarantee high-quality manufacture of laboratory developed tests for in-house-use conform requirements of the European <i>In-Vitro</i>-Diagnostics Regulation.

ISO 15189 is a sufficient instrument to guarantee high-quality manufacture of laboratory developed tests for in-house-use conform requirements of the European <i>In-Vitro</i>-Diagnostics Regulation.

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第一作者： Florent J L A,Vanstapel

第一单位： Laboratory Medicine, University Hospital Leuven, Leuven, Belgium.;Department of Public Health, Biomedical Sciences Group, Catholic University Leuven, Leuven, Belgium.

作者： Florent J L A,Vanstapel ^[1] ; Matthias,Orth ^[2] ; Thomas,Streichert ^[3] ; Ettore D,Capoluongo ^[4] ; Wytze P,Oosterhuis ^[5] ; Hikmet Can,Çubukçu ^[6] ; Francisco A,Bernabeu-Andreu ^[7] ; Marc,Thelen ^[8] ; Leo H J,Jacobs ^[9] ; Solveig,Linko ^[10] ; Harjit Pal,Bhattoa ^[11] ; Patrick M M,Bossuyt ^[12] ; Pika,Meško Brguljan ^[13] ; Guilaine,Boursier ^[14] ; Christa M,Cobbaert ^[15] ; Michael,Neumaier ^[16]

作者单位： Laboratory Medicine, University Hospital Leuven, Leuven, Belgium.;Department of Public Health, Biomedical Sciences Group, Catholic University Leuven, Leuven, Belgium. ^[1] Institute of Laboratory Medicine, Vinzenz von Paul Kliniken gGmbH, Stuttgart, Germany.;Medical Faculty Mannheim of Heidelberg University, Mannheim, Germany. ^[2] University of Cologne, Faculty of Medicine and University Hospital Cologne, Cologne, Germany. ^[3] Dipartimento di Medicina Molecolare e Biotecnologie Mediche, Università Federico II, Naples, Italy. ^[4] Department of Clinical Chemistry, Reinier Haga Medical Diagnostic Centre, Delft, The Netherlands. ^[5] Ankara University Stem Cell Institute, Ankara, Türkiye.;Department of Rare Diseases, General Directorate of Health Services, Turkish Ministry of Health, Ankara, Türkiye. ^[6] Servicio Bioquímica Análisis Clínicos, Hospital Universitario Puerta de Hierro Majadahonda (Madrid), Majadahonda, Spain. ^[7] Result Laboratory for Clinical Chemistry, Amphia Hospital, Breda, The Netherlands.;Department of Laboratory Medicine, Radboud University Medical Centre, Nijmegen, The Netherlands. ^[8] Laboratory for Clinical Chemistry and Hematology, Meander Medical Centre, Amersfoort, The Netherlands. ^[9] Linko Q-Solutions, Helsinki, Finland. ^[10] Department of Laboratory Medicine, Faculty of Medicine, University of Debrecen, Debrecen, Hungary. ^[11] Department of Epidemiology and Data Science, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, The Netherlands. ^[12] Department of Clinical Chemistry, University Clinic for Respiratory and Allergic Diseases Golnik, Golnik, Slovenia. ^[13] Department of Molecular Genetics and Cytogenomics, Rare and Autoinflammatory Diseases Unit, CHU Montpellier, Univ Montpellier, Montpellier, France. ^[14] Department of Clinical Chemistry and Laboratory Medicine, Leiden University Medical Centre, Leiden, The Netherlands. ^[15] Institute for Clinical Chemistry, Medical Faculty Mannheim of Heidelberg University, Mannheim, Germany. ^[16]