[ Validation des méthodes, tests immunohistochimiques PD-L1 dans les Cancers du Poumon Non à Petites Cellules (CPNPC): Laboratoire d’anatomie pathologique du CHU Ibn Rochd de Casablanca ]
Volume 43, Issue 3, September 2024, Pages 641–654
Mohamed Belcaid1, Nadia Anibat2, Oussama Aazzane3, Fatima Zahra Bakhtaoui4, Saida Stitou5, Abdeljalil Rezzaki6, Nabil Gaougaou7, and Mehdi Karkouri8
1 Laboratory of Cellular and Molecular Pathology, Faculty of Medicine and Pharmacy of Casablanca, Hassan II University of Casablanca, Morocco
2 Laboratoire de Pathologie Cellulaire et Moléculaire, Faculté de médecine et de pharmacie de Casablanca, Université Hassan II de Casablanca, Morocco
3 Laboratory of Cellular and Molecular Pathology, Faculty of Medicine and Pharmacy of Casablanca, Hassan II University of Casablanca, Morocco
4 Laboratoire d’Anatomie Pathologique, CHU Ibn Rochd de Casablanca, Morocco
5 Laboratoire d’Anatomie Pathologique, CHU Ibn Rochd de Casablanca, Morocco
6 Laboratory of Pathological Anatomy, CHU Ibn Rochd of Casablanca, Morocco
7 Département de biologie cellulaire et d’histologie, Faculté de médecine et de pharmacie, Université Ibn Zohr, Laayoune, Morocco
8 Laboratory of Cellular and Molecular Pathology, Faculty of Medicine and Pharmacy of Casablanca, Hassan II University of Casablanca, Morocco
Original language: French
Copyright © 2024 ISSR Journals. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Introduction: The validation of methods aims to satisfy normative requirements; it is among the essential measures for the development of the quality approach which makes it possible to provide proof of the quality of pathological anatomy techniques. Objective: Meet normative requirements in terms of validation of techniques, in order to contribute to the progression of the quality approach adopted in our pathological anatomy laboratory. Materials and methods: The expression of PD-L1 was carried out by immunohistochemistry using a monoclonal antibody (clone 22C3) on the Dako link 48 platform. Thus, the validation process involves a series of steps: Bibliographic search; description of the method; pre-analytical and analytical risk management; definition of performance criteria to be evaluated and experimental verification. Results: The risk analysis allowed us to highlight points for improvement regarding the pre-analytical and analytical phase. In terms of performance verification The results are very satisfactory. The performances of the manual method compared to the automatic technique are: sensitivity (82%), specificity (100%), Kappa coefficient (0.71), Matthew’s correlation coefficient (0.76). These results demonstrate that there is agreement between the two methods. Conclusion: The performance of our method was in compliance with current standards. Regarding the comparison of methods, the results of the manual method compared to the automated method demonstrated agreement between the two.
Author Keywords: Lung cancer, quality approach, method validation, PDL1 test, internal quality control.
Volume 43, Issue 3, September 2024, Pages 641–654
Mohamed Belcaid1, Nadia Anibat2, Oussama Aazzane3, Fatima Zahra Bakhtaoui4, Saida Stitou5, Abdeljalil Rezzaki6, Nabil Gaougaou7, and Mehdi Karkouri8
1 Laboratory of Cellular and Molecular Pathology, Faculty of Medicine and Pharmacy of Casablanca, Hassan II University of Casablanca, Morocco
2 Laboratoire de Pathologie Cellulaire et Moléculaire, Faculté de médecine et de pharmacie de Casablanca, Université Hassan II de Casablanca, Morocco
3 Laboratory of Cellular and Molecular Pathology, Faculty of Medicine and Pharmacy of Casablanca, Hassan II University of Casablanca, Morocco
4 Laboratoire d’Anatomie Pathologique, CHU Ibn Rochd de Casablanca, Morocco
5 Laboratoire d’Anatomie Pathologique, CHU Ibn Rochd de Casablanca, Morocco
6 Laboratory of Pathological Anatomy, CHU Ibn Rochd of Casablanca, Morocco
7 Département de biologie cellulaire et d’histologie, Faculté de médecine et de pharmacie, Université Ibn Zohr, Laayoune, Morocco
8 Laboratory of Cellular and Molecular Pathology, Faculty of Medicine and Pharmacy of Casablanca, Hassan II University of Casablanca, Morocco
Original language: French
Copyright © 2024 ISSR Journals. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Abstract
Introduction: The validation of methods aims to satisfy normative requirements; it is among the essential measures for the development of the quality approach which makes it possible to provide proof of the quality of pathological anatomy techniques. Objective: Meet normative requirements in terms of validation of techniques, in order to contribute to the progression of the quality approach adopted in our pathological anatomy laboratory. Materials and methods: The expression of PD-L1 was carried out by immunohistochemistry using a monoclonal antibody (clone 22C3) on the Dako link 48 platform. Thus, the validation process involves a series of steps: Bibliographic search; description of the method; pre-analytical and analytical risk management; definition of performance criteria to be evaluated and experimental verification. Results: The risk analysis allowed us to highlight points for improvement regarding the pre-analytical and analytical phase. In terms of performance verification The results are very satisfactory. The performances of the manual method compared to the automatic technique are: sensitivity (82%), specificity (100%), Kappa coefficient (0.71), Matthew’s correlation coefficient (0.76). These results demonstrate that there is agreement between the two methods. Conclusion: The performance of our method was in compliance with current standards. Regarding the comparison of methods, the results of the manual method compared to the automated method demonstrated agreement between the two.
Author Keywords: Lung cancer, quality approach, method validation, PDL1 test, internal quality control.
Abstract: (french)
Introduction: La validation des méthodes vise à satisfaire des exigences normatives, elle figure parmi les mesures essentielles du développement de la démarche qualité qui permet d’apporter la preuve de la qualité des techniques d’anatomie pathologique. Objectif: Répondre aux exigences normatives en terme de validation des techniques, afin de contribuer à la progression de la démarche qualité adoptée dans notre laboratoire d’anatomie pathologique. Matériels et méthodes: L’expression du PD-L1 a été réalisée par l’immunohistochimie à l’aide d’un anticorps monoclonale (clone 22C3) sur la plateforme Dako link 48. Ainsi, Le processus de validation, implique une série d’étapes: Recherche bibliographique; description de la méthode; maîtrise des risques pré-analytique et analytique; définition des critères de performances à évaluer et vérification expérimentale. Résultats: L’analyse des risques nous a permis de mettre en évidence les points à améliorer concernant la phase pré-analytique et analytique. En terme de vérification des performances Les résultats sont très satisfaisants. Les performances de la méthode manuelle par apport à la technique sur automate sont: la sensibilité (82%), la spécificité (100%), Le coefficient Kappa (0,71), le coefficient de corrélation de Matthew (0,76). Ces résultats démontrent qu’il y a une concordance entre les deux méthodes. Conclusion: Les performances de notre méthode étaient en conformité avec les normes en vigueur. Concernant la comparaison des méthodes, les résultats de la méthode manuelle par rapport à la méthode automatisée ont démontré une concordance entre les deux.
Author Keywords: Cancer du poumon, démarche qualité, validation des méthodes, test PDL1, contrôle qualité interne.
How to Cite this Article
Mohamed Belcaid, Nadia Anibat, Oussama Aazzane, Fatima Zahra Bakhtaoui, Saida Stitou, Abdeljalil Rezzaki, Nabil Gaougaou, and Mehdi Karkouri, “Validation of methods, PD-L1 immunohistochemical tests in Non-Small Cell Lung Cancers (NSCLC): Laboratory of pathological anatomy of the Ibn Rochd University Hospital in Casablanca,” International Journal of Innovation and Applied Studies, vol. 43, no. 3, pp. 641–654, September 2024.
