National Center for Clinical Laboratories, Beijing Hospital, National Center of Gerontology, Beijing, China; Beijing Engineering Research Center of Laboratory Medicine, Beijing Hospital, Beijing, China.
National Center for Clinical Laboratories, Beijing Hospital, National Center of Gerontology, Beijing, China; Beijing Engineering Research Center of Laboratory Medicine, Beijing Hospital, Beijing, China; Graduate School, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, China.
J Mol Diagn. 2020 Jul;22(7):876-884. doi: 10.1016/j.jmoldx.2020.03.007. Epub 2020 Apr 14.
The results of EML4-ALK testing are critical to manage ALK tyrosine kinase receptor inhibitor treatment. Thus, the accurate detection of ALK rearrangement is increasingly becoming a matter of serious concern. To address this issue, a long-term EML4-ALK proficiency testing (PT) scheme was launched in China in 2015, serving as an educational tool for assessing and improving the testing quality of EML4-ALK fusion 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 of EML4-ALK testing. 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 for EML4-ALK testing continuously improved over time by participating PT schemes, regardless of their method. However, care must be taken in standardized operations and validations.
EML4-ALK 检测结果对于管理 ALK 酪氨酸激酶受体抑制剂的治疗至关重要。因此，准确检测 ALK 重排越来越受到关注。为了解决这个问题，中国于 2015 年启动了一项长期的 EML4-ALK 能力验证（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。在 2015 年至 2019 年期间，共收集了 20 个不同的 PT 样本对三种不同变体和野生型样本的检测结果。通过评估检测方法、试剂盒和预分析实践来分析性能，以进一步展示 EML4-ALK 检测可靠性变化的情况。在这 5 年中，对来自 988 个实验室的 3224 个报告结果进行了评估，总体错误率为 5.36%。随着参与实验室数量的增加，每年不同方法的错误率都呈明显下降趋势。检测方法或试剂盒制造商的错误率没有明显差异。此外，实验室在参与更多轮次的 PT 计划后，其个体性能有所提高。数据表明，通过参与 PT 计划，中国各实验室的 EML4-ALK 检测性能随着时间的推移不断提高，而不管其使用的方法如何。但是，在标准化操作和验证方面需要谨慎。
