高质量临床微生物基因组参考数据库构建的思考  

Considerations on the Construction of a High-Quality Clinical Microbial Genome Reference Database

作　　者：刘东来[1] 吴林寰[2] 关文达[3] 庞慧芳 胡松年 许四宏[1] LIU Dong-lai;WU Lin-huan;GUAN Wen-da;PANG Hui-fang;HU Song-nian;XU Si-hong(National Institutes for Food and Drug Control,NMPA Key Laboratory for Quality Research and Evaluation of Medical Devices,NMPA Key Laboratory for Quality Research and Evaluation of In Vitro Diagnostics;National Microbiology Data Center,Institute of Microbiology,Chinese Academy of Sciences;Guangzhou Institute of Respiratory Health,the First Affiliated Hospital of Guangzhou Medical University;State Key Laboratory of Microbial Resources,Institute of Microbiology,Chinese Academy of Sciences)

机构地区：[1]中国食品药品检定研究院,国家药品监督管理局医疗器械质量研究与评价重点实验室,国家药品监督管理局体外诊断试剂质量研究与评价重点实验室 [2]中国科学院微生物研究所国家微生物科学数据中心 [3]广州医科大学附属第一医院广州呼吸健康研究院 [4]中国科学院微生物研究所微生物资源前期开发国家重点实验室

出　　处：《中国食品药品监管》2024年第6期32-39,共8页China Food & Drug Administration Magazine

基　　金：国家重点研发计划(2022YFF1203201、2022YFC2305300);中国食品药品检定研究院关键技术研究基金(GJJS-2022-2-2);药品监管科学全国重点实验室第二批课题(2024SKLDRS0212)。

摘　　要：病原宏基因组高通量测序(mNGS)技术因其检测时间短、分辨率高,能识别罕见、新发病原体引发的感染或者混合感染等优势,已经被广泛地应用于临床疑难感染的辅助诊断。然而,由于目前尚缺乏标准化生物信息学分析流程和高质量临床微生物基因组参考数据库等问题,一定程度上制约了该技术临床应用的进一步发展。本文介绍了高质量临床微生物基因组参考数据库建设现状,探讨了高质量临床微生物基因组参考数据库构建的技术要求、质量控制过程和实现方式,并提出相关思考和建议。Pathogen metagenome next-generation sequencing(mNGS)technology has been widely used in the detection of clinical infectious diseases due to its advantages of short detection time,high resolution,and the ability to identify infections caused by rare and emerging pathogens or mixed infections.However,the lack of standardized bioinformatics analyses and high-quality clinical microbial genome reference databases has restricted the further clinical application of this technology.This paper introduces the current status of high-quality clinical microbial genome reference database construction,discusses the technical requirements,quality control processes,and implementation methods building such a database,and provides related thoughts and suggestions.

关 键 词：病原宏基因组高通量测序 生物信息学分析 微生物基因组参考数据库 建设现状 技术要求 

分 类 号：R95[医药卫生—药学]