病原体宏基因组测序试剂生物信息学分析及阳性判断值确定的评价方法介绍

The introduction of methods of bioinformatics analysis and Cut⁃off value determination on pathogen metagenome Sequencing reagent

随着病原体宏基因组测序试剂在临床的广泛使用,对该类产品性能以及质量控制的要求相应引起重视。本文从质量评价的角度,简述病原体宏基因组测序试剂的生物信息学分析以及阳性判断值确定等研究及质量控制的方法。以期提高产品研发效率,推动行业发展,规范临床应用。

With the widespread use of pathogen metagenome sequencing reagents in clinic,the re⁃quirements for performance and quality control of such products have attracted corresponding attention.From the perspective of the performance evaluation,methods of bioinformatics analysis and study and quality control on cut⁃off value determination of pathogen metagenome sequencing reagent are briefly described in this article,In order to increase the research and development efficiency of products,contribute to the development of asso⁃ciated industry and standardized clinical application.