Echinoderm microtubule-associated protein-like 4 and anaplastic lymphoma kinase (ALK) fusion gene rearrangement is a key driver mutation in non-small cell lung cancer (NSCLC). Although Break-Apart ALK fluorescence in situ hybridization (FISH) is a reliable diagnostic method for detecting ALK gene rearrangement, it is also costly and time-consuming to use as a routine screening test. Our aim was to evaluate the clinical utility of a novel one-step, automated, rapid FISH (Auto-RaFISH) method developed to facilitate hybridization. This method takes advantage of the non-contact mixing effect of an alternating-current electric field. Ten representative specimens from 85 patients diagnosed at multiple centers with primary lung cancer with identified ALK-FISH status were collected. The specimens were all tested using FISH, RaFISH, and Auto-RaFISH. With both RaFISH protocols, the ALK test was completed within 4.5 h, as compared to the 20 h needed for the standard protocol. We found 100% agreement between the standard FISH, RaFISH, and new Auto-RaFISH based on the ALK status, and all methods stained equally well. These findings suggest that Auto-RaFISH could potentially serve as an automated clinical tool for prompt determination of ALK status in NSCLC.

中文翻译：

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使用非接触式交流电场混合开发用于间变性淋巴瘤激酶重排的新型一步自动快速原位杂交

棘皮动物微管相关蛋白样 4 和间变性淋巴瘤激酶 (ALK) 融合基因重排是非小细胞肺癌 (NSCLC) 的关键驱动突变。尽管分离 ALK 荧光原位杂交 (FISH) 是一种可靠的检测 ALK 基因重排的诊断方法，但作为常规筛查测试使用它也是昂贵且耗时的。我们的目的是评估一种为促进杂交而开发的新型一步法、自动化、快速 FISH (Auto-RaFISH) 方法的临床效用。这种方法利用了交流电场的非接触混合效应。收集了来自多个中心诊断出的 85 名原发性肺癌患者的 10 份代表性标本，这些患者的 ALK-FISH 状态已确定。标本均使用 FISH、RaFISH 和 Auto-RaFISH 进行测试。使用两种 RaFISH 协议，ALK 测试在 4.5 小时内完成，而标准协议需要 20 小时。我们发现基于 ALK 状态的标准 FISH、RaFISH 和新的 Auto-RaFISH 之间 100% 一致，并且所有方法的染色效果都一样。这些发现表明 Auto-RaFISH 有可能作为一种自动临床工具，用于及时确定 NSCLC 中的 ALK 状态。