摘要
目的制备模拟临床样本的表皮生长因子受体(epidermal growth factor receptor EGFR)基因突变检测质控品,评估其临床适用性。方法选择含EGFR不同突变位点和无EGFR突变位点细胞,培养收集后制作成蜡卷。用三种临床常用试剂盒检测,并评估其均一性和稳定性。将含不同突变型5份样本的样本盘,随机编码后发送至参评实验室,评价回报结果。结果三种不同试剂检测样本盘结果一致。结果显示质控品均匀,室温放置可稳定12个月。28家实验室5个样本符合率分别为92.88%,96.43%,78.57%,96.43%和100%,突变型样本和野生型样本的符合率分别为91.07%(102/112)和100%(28/28)。结论研制的EGFR基因突变质控品具有较好的临床适用性,可用于室内质量控制和室间质量评价。
Objective To develop quality control materials which can simulate clinical specimens for epidermal growth factor receptor(EGFR) mutation determination and evaluate the application in clinical laboratories. Methods Cells containing different EGFR mutations and cells without EGFR mutation were cultured and sectioned into wax rolls. The quality control materials were detected by three different commercial kits. The homogeneity and stability were evaluated. The panel consisted of 5 blindly coded samples distributed to external quality assessment participates. The results from the participants were summarized and analyzed. Results The results of three different reagents were consistent. The quality control materials were homogeneity and could be stable at room temperature for 12 months. 28 valid lab results were received. The coincidence rate of 5 sample were 92.88%, 96.43%, 78.57%, 96.43% and 100% respectively. The overall coincidence rate of positive samples and negative ones were 91.07%(102/112) and 100%(28/28). Conclusion The quality control materials had good clinical applicability, and they can be used for internal quality control and external quality assessment materials.
作者
蒋玲丽
黄中强
王雪亮
鲍芸
王青
肖艳群
JIANG Ling-li;HUANG Zhong-qiang;WANG Xue-liang;BAO Yun;WANG Qing;XIAO Yan-qun(Shanghai Center for Clinical Laboratory,Shanghai 200126,China)
出处
《现代检验医学杂志》
CAS
2020年第2期145-147,152,共4页
Journal of Modern Laboratory Medicine
基金
上海市卫生和计划生育委员会资助项目(201640187)。
关键词
非小细胞肺癌
表皮生长因子受体(EGFR)
质控品
non-small cell lung cancer
epidermal growth factor receptor(EGFR)
quality control material
