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Jurmeister, Philipp; Vollbrecht, Claudia; Joehrens, Korinna; Aust, Daniela; Behnke, Anke; Stenzinger, Albrecht; Penzel, Roland; Endris, Volker; Schirmacher, Peter; Fisseler-Eckhoff, Annette; Neumann, Jens; Kirchner, Thomas; Buettner, Reinhard; Merkelbach-Bruse, Sabine; Kreipe, Hans; Jonigk, Danny; Jochum, Wolfram; Rodriguez, Regulo; Dietel, Manfred; Horst, David; Hummel, Michael and Laffert, Maximilian von (2021): Status quo of ALK testing in lung cancer: results of an EQA scheme based on in-situ hybridization, immunohistochemistry, and RNA/DNA sequencing. In: Virchows Archiv, Vol. 479, No. 2: pp. 247-255

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With this external quality assessment (EQA) scheme, we aim to investigate the diagnostic performance of the currently available methods for the detection of ALK alterations in non-small cell lung cancer on a national scale, namely, in situ hybridization (ISH), immunohistochemistry (IHC), and RNA/DNA sequencing (NGS). The EQA scheme cohort consisted of ten specimens, including four ALK positive and six ALK negative samples, which were thoroughly pretested using IHC, ISH, and RNA/DNA NGS. Unstained tumor sections were provided to the 57 participants, and the results were retrieved via an online questionnaire. ISH was used by 29, IHC by 38, and RNA/DNA sequencing by 19 participants. Twenty-eight institutions (97%) passed the ring trial using ISH, 33 (87%) by using IHC, and 18 (95%) by using NGS. The highest sensitivity and interrater agreement (Fleiss ' kappa) was observed for RNA/DNA sequencing (99%, 0.975), followed by ISH (94%, 0.898) and IHC (92%, 0.888). However, the proportion of samples that were not evaluable due to bad tissue quality was also higher for RNA/DNA sequencing (4%) compared with ISH (0.7%) and IHC (0.5%). While all three methods produced reliable results between the different institutions, the highest sensitivity and concordance were observed for RNA/DNA sequencing. These findings encourage the broad implementation of this method in routine diagnostic, although the application might be limited by technical capacity, economical restrictions, and tissue quality of formalin-fixed samples.

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