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

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... Throughout this 5-year EML4-ALK rearrangement detection PT scheme, a large amount of valuable historical data was collected. As it is of interest to investigate whether the performance of EML4-ALK rearrangement tests has changed over th..... READ ARTICLE

The Journal of Molecular Diagnostics DOI:10.1016/j.jmoldx.2020.03.007

Authors: Rongxue Peng, Rui Zhang, Jiawei Zhang, Ping Tan, Yanxi Han, Kuo Zhang, Guigao Lin, Jiehong Xie, Jinming Li