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Status quo of ALK testing in lung cancer: results of an EQA scheme based on in-situ hybridization, immunohistochemistry, and RNA/DNA sequencing
Virchows Archiv ( IF 3.4 ) Pub Date : 2021-06-25 , DOI: 10.1007/s00428-021-03106-5
Philipp Jurmeister 1, 2 , Claudia Vollbrecht 1, 3 , Korinna Jöhrens 4, 5 , Daniela Aust 4 , Anke Behnke 1 , Albrecht Stenzinger 6, 7 , Roland Penzel 6 , Volker Endris 6 , Peter Schirmacher 6, 7 , Annette Fisseler-Eckhoff 8 , Jens Neumann 9 , Thomas Kirchner 9, 10 , Reinhard Büttner 11 , Sabine Merkelbach-Bruse 11 , Hans Kreipe 12 , Danny Jonigk 12 , Wolfram Jochum 13 , Regulo Rodriguez 13 , Manfred Dietel 1 , David Horst 1, 2 , Michael Hummel 1 , Maximilian von Laffert 1
Affiliation  

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.



中文翻译:

肺癌 ALK 检测的现状:基于原位杂交、免疫组织化学和 RNA/DNA 测序的 EQA 方案的结果

通过这种外部质量评估 (EQA) 计划,我们旨在调查目前可用的方法在全国范围内检测非小细胞肺癌中 ALK 改变的诊断性能,即原位杂交 (ISH)、免疫组织化学(IHC) 和 RNA/DNA 测序 (NGS)。EQA 方案队列由 10 个样本组成,包括 4 个 ALK 阳性样本和 6 个 ALK 阴性样本,这些样本使用 IHC、ISH 和 RNA/DNA NGS 进行了彻底的预测试。向 57 名参与者提供未染色的肿瘤切片,并通过在线问卷检索结果。29 人使用 ISH,38 人使用 IHC,19 名参与者使用 RNA/DNA 测序。28家(97%)使用ISH通过环试,33家(87%)使用IHC,18家(95%)使用NGS。RNA/DNA 测序的灵敏度和交互者间一致性 (Fleiss ' kappa) 最高 (99%, 0.975),其次是 ISH (94%, 0.898) 和 IHC (92%, 0.888)。然而,与 ISH (0.7%) 和 IHC (0.5%) 相比,RNA/DNA 测序 (4%) 由于组织质量差而无法评估的样本比例也更高。虽然所有三种方法在不同机构之间都产生了可靠的结果,但 RNA/DNA 测序的灵敏度和一致性最高。这些发现鼓励在常规诊断中广泛实施这种方法,尽管应用可能会受到技术能力、经济限制和福尔马林固定样本的组织质量的限制。与 ISH (0.7%) 和 IHC (0.5%) 相比,RNA/DNA 测序 (4%) 由于组织质量差而无法评估的样本比例也更高。虽然所有三种方法在不同机构之间都产生了可靠的结果,但 RNA/DNA 测序的灵敏度和一致性最高。这些发现鼓励在常规诊断中广泛实施这种方法,尽管应用可能会受到技术能力、经济限制和福尔马林固定样本的组织质量的限制。与 ISH (0.7%) 和 IHC (0.5%) 相比,RNA/DNA 测序 (4%) 由于组织质量差而无法评估的样本比例也更高。虽然所有三种方法在不同机构之间都产生了可靠的结果,但 RNA/DNA 测序的灵敏度和一致性最高。这些发现鼓励在常规诊断中广泛实施这种方法,尽管应用可能会受到技术能力、经济限制和福尔马林固定样本的组织质量的限制。

更新日期:2021-06-28
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