Humans; Belgium; Immunohistochemistry; Laboratories; Research Design; CE-IVD test; immunohistochemical test; laboratory-developed test; validation; verification; Pathology and Forensic Medicine; Histology; Medical Laboratory Technology
Abstract :
[en] Analytical verification and validation of immunohistochemical (IHC) tests and their equipment are common practices for today's anatomic pathology laboratories. Few references or guidelines are available on how this should be performed. The study of Sciensano (the Belgian national competent authority regarding licensing of medical laboratories) performed in 2016, demonstrated a significant interlaboratory variation in validation procedures of IHC tests among Belgian laboratories. These results suggest the unavailability of practical information on the approach to the verification and validation of these tests. The existing Belgian Practice Guideline for the implementation of a quality management system in anatomic pathology laboratories has been reviewed to meet this demand and, in addition, to prepare the laboratories for the EU-IVD revised regulations (IVDR). This paper describes Belgian recommendations for the verification and validation of IHC tests before implementation, for ongoing validation, and for revalidation. For each type of test (according to the IVDR classification and the origin) and its intended use (purpose), it addresses how to perform analytical verification/validation by recommending: (1) the number of cases in the validation set, (2) the performance characteristics to be evaluated, (3) the objective acceptance criteria, (4) the evaluation method for the obtained results, and (5) how and when to revalidate. A literature study and a risk analysis taking into account the majority of variables regarding verification/validation of methods have been performed, resulting in an expert consensus recommendation that is a compromise among achievability, affordability, and patient safety. This new consensus recommendation has been incorporated in the aforementioned ISO 15189:2012-based Practice Guideline.
Disciplines :
Laboratory medicine & medical technology
Author, co-author :
Verbeke, Hannelien; Department of Quality of laboratories, Sciensano
Van Hecke, Donald; Laboratory of Anatomic Pathology, AZ St. Lucas, Bruges
Bauraing, Caroline; Institute of Anatomic Pathology and Genetics, Gosselies
Dierick, Anne Marie; Department of Quality of laboratories, Sciensano
Colleye, Orphal ; Université de Liège - ULiège > Département des sciences biomédicales et précliniques
Dalle, Ignace; Laboratory of Anatomic Pathology, AZ St. Lucas, Bruges
Dewachter, Kathleen; Laboratory of Anatomic Pathology, AZ St. Maarten, Mechelen
Guiot, Yves; Laboratory of Anatomic Pathology, Université Catholique Louvain, Brussels
Lequeu, Raphael; Institute of Anatomic Pathology and Genetics, Gosselies
Vanderheyden, Nancy; Laboratory of Anatomic Pathology, UZ Leuven, Leuven
Zwaenepoel, Karen; Laboratory of Anatomic Pathology, UZ Antwerp, Antwerp
Croes, Romaric; Laboratory of Anatomic Pathology, AZ St. Blasius, Dendermonde, Belgium
Language :
English
Title :
Belgian Recommendations for Analytical Verification and Validation of Immunohistochemical Tests in Laboratories of Anatomic Pathology.
Publication date :
01 January 2024
Journal title :
Applied Immunohistochemistry and Molecular Morphology
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