利用荧光PCR⁃毛细管电泳法评价微卫星不稳定性检测国家参考品  

Evaluation of the national reference materials for microsatellite instability using fluorescence PCR⁃capillary electrophoresis

作　　者：张文新 黄传峰[1] 孙楠[1] 高飞[1] 于婷[1] 孙晶 曲守方[1] 黄杰[1] ZHANG Wenxin;HUANG Chuanfeng;SUN Nan;GAO Fei;YU Ting;QU Shoufang;HUANG Jie(National Institutes for Food and Drug Control,Beijing,China,100050)

机构地区：[1]中国食品药品检定研究院,北京100050

出　　处：《分子诊断与治疗杂志》2020年第5期565-569,574,共6页Journal of Molecular Diagnostics and Therapy

基　　金：生殖健康及重大出生缺陷防控研究(2016YFC1000300)。

摘　　要：目的利用荧光PCR⁃毛细管电泳法评价微卫星不稳定性(MSI)检测国家参考品,验证国家参考品用于相关试剂盒性能评价及临床实验室质量评价的适用性。方法采用3家不同公司的微卫星不稳定性检测试剂盒(荧光PCR⁃毛细管电泳法)对国家参考品进行阳性参考品符合率、阴性参考品符合率和检测限项目的检测。结果对国家参考品中的62例样本进行检测,其中阳性参考品的结果均为微卫星高度不稳定,阴性参考品的结果均为微卫星稳定,LOD1及LOD3的20%、10%检测限参考品均检出微卫星高度不稳定,但其5%检测限参考品有1家公司未检出相应的微卫星高度不稳定状态。LOD4、LOD5、LOD6及LOD7检测限参考品检测结果均为微卫星稳定或微卫星低度不稳定。结论微卫星不稳定性检测国家参考品,适用于荧光PCR⁃毛细管电泳法试剂盒的性能评价及临床实验室的质量评价。Objective To verify the applicability of performance evaluation of relevant kits and quality evaluation of clinical laboratories,the national reference materials for microsatellite instability(MSI)were evaluated by fluorescence PCR capillary electrophoresis.Methods The national reference materials were detected by microsatellite instability detection kit(fluorescence PCR⁃capillary electrophoresis)from three different companies to determine the coincident rate of positive and negative reference,and the limit of detec⁃tion.Results In 62 cases of testing samples,the results of positive references were all microsatellite insta⁃bility⁃high(MSI⁃H).The results of negative reference were all microsatellite stability(MSS).The results of LOD1 and LOD3 references with tumor concentration 20%and 10%for the limit of detection were MSI⁃H,but the corresponding MSI⁃H status was not detected by only one company for LOD1 and LOD3 references with tumor concentration 5%.LOD4,LOD5,LOD6 and LOD7 references for the limit of detection were all MSS or microsatellite instability⁃low(MSI⁃L).Conclusion The national reference materials for microsatel⁃lite instability testing are suitable for evaluation of the performance of kits and the quality of clinical laborato⁃ries based on the method of fluorescence PCR⁃capillary electrophoresis.

关 键 词：微卫星不稳定性 国家参考品 荧光PCR⁃毛细管电泳法 

分 类 号：R440[医药卫生—诊断学]