Antonio Marchetti1, Massimo Barberis, Mauro Papotti, Giulio Rossi, Renato Franco, Sara Malatesta, Fiamma Buttitta, Andrea Ardizzoni, Lucio Crinò, Cesare Gridelli, Gian Luigi Taddei, Claudio Clemente, Giorgio Scagliotti, Nicola Normanno, Carmine Pinto. 1. *Center of Predictive Molecular Medicine, Center of Excellence on Aging, University-Foundation, Chieti, Italy; †Division of Pathology and Laboratory Medicine, European Institute of Oncology, Milan, Italy; ‡Division of Anatomic Pathology, San Luigi Hospital and University of Turin, Orbassano, Italy; §Pathology Department, Policlinico di Modena, Modena, Italy; ‖Diagnostic and Laboratory Medicine, INT-Fondazione "G.Pascale", Naples, Italy; ¶Medical Oncology Unit, University Hospital, Parma, Italy; #Department of Medical Oncology, Perugia Hospital, Perugia, Italy; **Division of Medical Oncology, S.G. Moscati Hospital, Avellino, Italy; ††Department of Human Pathology and Oncology, University of Florence, Florence, Italy; ‡‡Pathology Department, Casa di Cura San Pio X and I.R.C.C.S. Policlinico San Donato, Milano, Italy; §§Thoracic Oncology Unit, University of Torino, San Luigi Hospital, Torino, Italy; ‖‖Cell Biology and Biotherapy Unit, INT-Fondazione "G.Pascale", Naples, Italy; and ¶¶Medical Oncology Unit, S. Orsola-Malpighi Hospital, Bologna, Italy.
Abstract
INTRODUCTION: The Italian Association of Medical Oncology and the Italian Society of Anatomic Pathology and Diagnostic Cytopathology organized an external quality assessment (EQA) scheme for anaplastic lymphoma kinase (ALK) rearrangement by florescence in situ hybridization (FISH) analysis in non-small-cell lung cancer (NSCLC). METHODS: Sections from tissue microarrays, each including 10 NSCLC samples with known ALK status, were first validated in five referral laboratories and then provided to 37 participating centers. The laboratories were requested to perform the FISH test, using their usual protocols, and to complete the analysis within 3 weeks. By using a predefined scoring system, two points were assigned in case of correct genotype and zero points to false-negative or false-positive results. The threshold value to pass the EQA scheme was set at 18 points. Two rounds were planned. RESULTS: Thirty-four centers submitted the results within the established deadline. Several errors in the evaluation of genotype (n = 18) were reported, with both false-positive (n = 7) and false-negative (n = 11) results. Test failure occurred in seven cases. Two samples were found to be critical by two referral laboratories and seven participating centers. Twenty-six (70%) laboratories passed the first round and six the second round. Overall, 32 (86%) laboratories passed the ALK EQA scheme. CONCLUSIONS: The results of this first EQA scheme for ALK testing in NSCLC cancer patients indicate that ALK analysis is performed with adequate quality in most Italian laboratories and highlight the importance of EQA in revealing methodological problems that need to be addressed to further increase the reproducibility of molecular tests.
INTRODUCTION: The Italian Association of Medical Oncology and the Italian Society of Anatomic Pathology and Diagnostic Cytopathology organized an external quality assessment (EQA) scheme for anaplastic lymphoma kinase (ALK) rearrangement by florescence in situ hybridization (FISH) analysis in non-small-cell lung cancer (NSCLC). METHODS: Sections from tissue microarrays, each including 10 NSCLC samples with known ALK status, were first validated in five referral laboratories and then provided to 37 participating centers. The laboratories were requested to perform the FISH test, using their usual protocols, and to complete the analysis within 3 weeks. By using a predefined scoring system, two points were assigned in case of correct genotype and zero points to false-negative or false-positive results. The threshold value to pass the EQA scheme was set at 18 points. Two rounds were planned. RESULTS: Thirty-four centers submitted the results within the established deadline. Several errors in the evaluation of genotype (n = 18) were reported, with both false-positive (n = 7) and false-negative (n = 11) results. Test failure occurred in seven cases. Two samples were found to be critical by two referral laboratories and seven participating centers. Twenty-six (70%) laboratories passed the first round and six the second round. Overall, 32 (86%) laboratories passed the ALK EQA scheme. CONCLUSIONS: The results of this first EQA scheme for ALK testing in NSCLC cancerpatients indicate that ALK analysis is performed with adequate quality in most Italian laboratories and highlight the importance of EQA in revealing methodological problems that need to be addressed to further increase the reproducibility of molecular tests.
Authors: Cecily P Vaughn; José Luis Costa; Harriet E Feilotter; Rosella Petraroli; Varun Bagai; Anna Maria Rachiglio; Federica Zito Marino; Bastiaan Tops; Henriette M Kurth; Kazuko Sakai; Andrea Mafficini; Roy R L Bastien; Anne Reiman; Delphine Le Corre; Alexander Boag; Susan Crocker; Michel Bihl; Astrid Hirschmann; Aldo Scarpa; José Carlos Machado; Hélène Blons; Orla Sheils; Kelli Bramlett; Marjolijn J L Ligtenberg; Ian A Cree; Nicola Normanno; Kazuto Nishio; Pierre Laurent-Puig Journal: BMC Cancer Date: 2018-08-16 Impact factor: 4.430
Authors: Philipp Jurmeister; Claudia Vollbrecht; Korinna Jöhrens; Daniela Aust; Anke Behnke; Albrecht Stenzinger; Roland Penzel; Volker Endris; Peter Schirmacher; Annette Fisseler-Eckhoff; Jens Neumann; Thomas Kirchner; Reinhard Büttner; Sabine Merkelbach-Bruse; Hans Kreipe; Danny Jonigk; Wolfram Jochum; Regulo Rodriguez; Manfred Dietel; David Horst; Michael Hummel; Maximilian von Laffert Journal: Virchows Arch Date: 2021-06-25 Impact factor: 4.064