Immunohistochemistry as a screening tool for ALK rearrangement in NSCLC: evaluation of five different ALK antibody clones and ALK FISH
Immunohistochemistry as a screening tool for ALK rearrangement in NSCLC: evaluation of five different ALK antibody clones and ALK FISH
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DOI：
10.1111/his.12399
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发表时间：
2014-09-01
期刊：
影响因子：
6.4
通讯作者：
Dietze, Otto
中科院分区：
文献类型：
--
作者：
Hutarew, Georg;Hauser-Kronberger, Cornelia;Dietze, Otto
AimsALKFISH分析用作证明ALK重排的参考标准，这使肺腺癌患者有资格接受ALK抑制剂治疗。本研究的目的是找到筛选ALK抗体克隆的最佳阳性和最佳阴性百分比协议ALKFISH.Methods和results 303肺腺癌进行了评估与ALKFISH和染色与5个ALK抗体克隆（5A 4; D5 F3; ALK 1; ALK 01; SP 8）与标准化检测系统。使用OptiView增强型检测和扩增系统额外评估D5 F3。ALKFISH发现14例（4.6%）存在ALK重排。对于D5 F3和5A 4，这些在所有强度下染色。结论D5 F3与OptiView仅对重排病例进行强染色，无一例假阳性或假阴性。随后所需的ALKFISH分析数量将从303例减少到14例（-95.4%），大大减少了时间、工作和成本，而不会损失诊断质量和准确性。
AimsALKFISH analysis is used as the reference standard to demonstrate ALK rearrangements, which qualify patients with pulmonary adenocarcinomas for therapy with ALK inhibitors. The aim of this study was to find screening ALK antibody clones with the best positive and best negative percentage agreement with ALKFISH.Methods and resultsThree hundred and three pulmonary adenocarcinomas were evaluated with ALKFISH and stained with five ALK antibody clones (5A4; D5F3; ALK1; ALK01; SP8) with standardized detection systems. D5F3 was additionally assessed using the OptiView enhanced detection and amplification system. ALKFISH found 14 cases (4.6%) that harboured ALK rearrangements. These stained at all intensities for D5F3 and 5A4. To identify rearranged cases among stained cases, we subsequently analysed all immunohistochemically positive cases with ALKFISH.ConclusionsD5F3 with OptiView exclusively stained rearranged cases with strong intensity, without a single false-positive or false-negative case. The number of subsequent ALKFISH analyses required would have decreased from 303 to 14 cases (-95.4%), reducing significantly the time, work and costs without any loss of diagnostic quality and accuracy.