2017年度人EGFR基因突变检测试剂盒抽验质量分析  

Quality analysis of human EGFR gene mutation detection kits in 2017

作　　者：孙楠[1] 于婷[1] 黄杰[1] 曲守方[1] SUN Nan;YU Ting;HUANG Jie;QU Shoufang(The Key Laboratory of Biotechnology Product Test Method and Its Standardization of the Ministry of Health,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,卫生部生物技术产品检定方法及其标准化重点实验室,北京100050

出　　处：《分子诊断与治疗杂志》2018年第5期315-319,351,共6页Journal of Molecular Diagnostics and Therapy

基　　金：国家高技术研究发展计划(863计划):新型体外诊断试剂质量评价体系和国家参考物质研究项目(2011AA02A115)

摘　　要：目的按照国家体外诊断试剂抽验工作方案,从8家企业共抽检9批次的"人EGFR基因突变检测试剂盒",评价该试剂盒的质量。方法依据企业产品技术要求,使用企业参考品对试剂盒的准确性、特异性、检测限和重复性进行检验,同时依据EGFR基因突变检测试剂盒即将实施的行业标准,使用统一参考品,对试剂盒进行探索性研究。结果9批次试剂均符合各自产品技术要求。探索性研究发现,试剂盒准确性和检测限均有1批次的1个突变位点未检出。结论各企业产品技术要求存在差异,影响产品质量。建议将来及时根据行业标准更新企业技术要求,并统一使用国家参考品进行检测。Objective According to the national in vitro diagnostic reagent sampling program,9 batches of“human EGFR gene mutation detection kit”were sampled from 8 companies to evaluate the quality of the kit.Methods The accuracy,specificity,limit of detection and repeatability were verified in accordance with the product technical requirements.Exploratory study was also contacted by using the national reference and referring to the industry standards to be released.Results All of testing reagents met the product technical requirements of each company.According to the industry standard to be implemented,one mutation from one batch was not detected in the accuracy and limit of detection.Conclusion There are differences in technical requirements of each company's products,which affect product quality.It is recommended that the technical requirements of the enterprise be updated in a timely manner according to industry standards,and the national reference products should be used for testing.

关 键 词：EGFR 检测试剂盒 质量分析 准确性 特异性 检测限 

分 类 号：R440[医药卫生—诊断学]