结核分枝杆菌复合群脱氧核糖核酸检测试剂分析性能评估浅析

The analytic performance studies of Mycobacterium tuberculosis Complex DNA detection reagents

结核分枝杆菌复合群脱氧核糖核酸（deoxyribonucleic acid，DNA）检测试剂的分析性能评估资料是该类试剂注册申报资料的一项重要的技术资料。作者总结分析性能评估资料需要包括的主要项目与相关的技术细节，指导生产企业科学合理地进行试剂研发。

The material of the analytic performance studies of Mycobacterium tuberculosis Complex DNA detection reagents is an important technical document of the application materials for reagent registration. The main aim of this paper is to summarize the main proiects and related technical details of analytic performance evaluation studies in order to guide manufactures to conduct research and development of reagents scientifically and rationally.