detection method

检测方法
  • 文章类型: Journal Article
    间变性淋巴瘤激酶(ALK)重排的存在定义了非小细胞肺癌(NSCLC)的分子亚型。ALK抑制剂(ALKIs)在ALK阳性晚期NSCLC患者中具有显著的临床获益;因此,准确选择,快速,和适当的ALK测试方法,以筛选适合抗ALK治疗的患者。近年来,ALKIs的开发和临床应用取得了很大进展,以及我们对获得性耐药机制的理解。同时,新的ALK辅助诊断平台已被开发并应用于临床实践。尽管许多研究表明,这些平台之间的一致性很高,在测试过程中不断出现新的问题。为患者带来最大利益,首先选择合适的测试方法,然后制定,优化,并根据检测人群和标本类型遵守标准化的检测流程。随着临床实践数据的不断积累,ALK检测质量控制的经验,以及多中心研究的结果,更新的专家共识是必要的。参与讨论和制定本指南的专家具有丰富的理论背景和临床检验经验,这确保了本指南中提供的信息的实用价值。
    The presence of anaplastic lymphoma kinase (ALK) rearrangement defines a molecular subtype of non-small cell lung cancer (NSCLC). ALK inhibitors (ALKIs) confer significant clinical benefits in patients with ALK-positive advanced NSCLC; therefore, it is of great clinical significance to select accurate, rapid, and appropriate ALK testing methods to screen for patients who are suitable for anti-ALK treatment. In recent years, great progress has been made in the development and clinical application of ALKIs, as well as in our understanding of acquired drug resistance mechanisms. Meanwhile, new ALK companion diagnostic platforms have been developed and applied in clinical practice. Although many studies have shown that there is a high rate of concordance among these platforms, new problems continue to appear during testing. To maximize the benefit for patients, accurate testing results can be obtained by first selecting the appropriate testing method and then formulating, optimizing, and complying with the standardized testing process in accordance with the testing population and specimen types. With the ongoing accumulation of clinical practice data, experience from quality control of ALK testing, and results from multicenter research, an updated expert consensus is necessary. The experts who participated in the discussion and development of this guideline have a rich background in theoretical and clinical testing experience, which ensures the practical value of the information presented in this guideline.
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