一项验证研究表明，新型ALK免疫组化检测法（Dako OTI1A4克隆）是一种敏感可靠的标志物，用于确定肺腺癌中的ALK基因重排。
Novel ALK immunohistochemistry assay (clone OTI1A4, Dako) is a sensitive, reliable marker for identifying ALK rearrangements in lung adenocarcinomas : A validation study.
发表日期：2023 Sep 08
作者：
Ozgur Can Eren, Cisel Aydin Mericoz, Emine Bozkurtlar, Pinar Bulutay, Arzu Baygul, Ibrahim Kulac
来源：
AMERICAN JOURNAL OF CLINICAL PATHOLOGY
摘要：
我们首次提出一项研究，对最近的Dako ALK检测试剂（克隆OTI1A4，体外诊断）在肺腺癌中检测ALK重排方面进行验证。收集了2011年至2023年间的肺腺癌病例，共获得203个样本，用于创建队列。所有病例均使用了Dako ALK OTI1A4和Ventana ALK D5F3进行染色，并由3名病理学家独立进行评估。评估了试剂的相关性，包括敏感性和特异性。队列（n = 203）由切除、穿刺活检和细胞块组成。Dako ALK OTI1A4和Ventana ALK D5F3观察结果的一致性“几乎完美”，κ = 0.89。Dako ALK OTI1A4试剂在55个分子确认的病例（包括30个ALK重排和25个非ALK重排）的亚组中，敏感性和特异性分别为93.3%和96%。免疫组化检测提供了一种有效且价格合理的替代方法，特别适用于无法进行分子确证测试的情况。鉴于很高的试剂间和分子间相符度，我们认为这种新的Dako OTI1A4试剂可以可靠地用于识别ALK重排病例。©美国临床病理学学会，2023年。
We present the first study validating the recent Dako ALK assay (clone OTI1A4, in vitro diagnostic) for detecting ALK rearrangements in lung adenocarcinoma.Lung adenocarcinoma cases between 2011 and 2023 were retrospectively collected to create a cohort of 203 samples. Cases were stained with Dako ALK OTI1A4 and Ventana ALK D5F3 and reviewed by 3 pathologists independently. Correlation between assays, including their sensitivity and specificity, was evaluated.The cohort (n = 203) consisted of resections, core needle biopsies, and cell blocks. Agreement between Dako ALK OTI1A4 and Ventana ALK D5F3 assays was "almost perfect," with κ = 0.89. The sensitivity and specificity of the Dako ALK OTI1A4 assay were 93.3% and 96%, respectively, in a subgroup of 55 molecularly confirmed cases (n = 30 with and n = 25 without ALK rearrangement).Immunohistochemistry-based assays provide a valid and reasonably priced alternative, especially in settings where molecular confirmatory tests are neither offered nor accessible. Given high interassay and molecular concordance, we propose that the novel Dako OTI1A4 assay can be reliably used to identify cases with ALK rearrangement.© American Society for Clinical Pathology, 2023.