Continual Improvement of the Reliability of EML4-ALK Rearrangement Detection in Non-Small-Cell Lung Cancer A Long-Term Comparison of ALK Detection in China
Continual Improvement of the Reliability of EML4-ALK Rearrangement Detection in Non-Small-Cell Lung Cancer A Long-Term Comparison of ALK Detection in China
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DOI：
10.1016/j.jmoldx.2020.03.007
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发表时间：
2020-07-01
影响因子：
4.1
通讯作者：
Li，Jinming
中科院分区：
文献类型：
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作者：
Peng，Rongxue;Zhang，Rui;Li，Jinming
EML4-ALK检测的结果对管理ALK酪氨酸激酶受体抑制剂的治疗至关重要。因此，ALK重排的准确检测日益成为人们关注的问题。为了解决这个问题，2015年，中国启动了长期的EML4-ALK能力测试(PT)计划，作为评估和提高EML4-ALK融合检测测试质量的教育工具。2015至2019年间，收集了20个不同PT样本的回复，这些样本询问了三个不同的变种和野生型样本。通过评估用于进一步显示EML4-ALK测试可靠性的变化条件的检测方法、试剂盒和分析前实践来分析性能。在这5年中，对988个实验室报告的3224个结果进行了评估，总体错误率为5.36%。随着参与实验室数量的增加，每种不同方法的错误率多年来都呈现出明显下降的趋势。测试方法或试剂盒制造商之间的错误率没有明显差异。此外，当实验室参与更多的PT计划轮次时，他们的个人表现有所改善。数据表明，通过参与PT计划，中国各个实验室在EML4-ALK测试中的表现随着时间的推移而不断提高，无论他们的方法如何。然而，在标准化操作和验证中必须注意。
The results ofEML4-ALKtesting are critical to manage ALK tyrosine kinase receptor inhibitor treatment. Thus, the accurate detection ofALKrearrangement is increasingly becoming a matter of serious concern. To address this issue, a long-termEML4-ALKproficiency testing (PT) scheme was launched in China in 2015, serving as an educational tool for assessing and improving the testing quality ofEML4-ALKfusion detection. Responses across 20 different PT samples interrogating three different variants and wild-type samples were collected between 2015 and 2019. Performance was analyzed by evaluating the detection methods, kits, and pre-analytic practices used to further display the landscape of changing conditions of the reliability ofEML4-ALKtesting. During the 5 years, 3224 results reported from 988 laboratories were evaluated, with an overall error rate of 5.36%. Along with an increasing number of participating laboratories, the error rate within each of the different methods showed a significantly downward trend over the years. No obvious differences in the error rates were found regarding the testing methods or kit manufacturers. Moreover, the individual performance of the laboratories improved when they participated in more PT scheme rounds. The data demonstrated that the performance of individual Chinese laboratories forEML4-ALKtesting continuously improved over time by participating PT schemes, regardless of their method. However, care must be taken in standardized operations and validations.