[Construction and quality assurance of metagenomic next-generation sequencing platform in pathogen detection]

Zhonghua Yi Xue Za Zhi. 2023 Apr 18;103(15):1092-1097. doi: 10.3760/cma.j.cn112137-20220825-01801.
[Article in Chinese]

Abstract

Early diagnosis remains the key to prevent and control infectious diseases. In recent years, metagenomic next-generation sequencing (mNGS) technology breaks through the limitations of conventional culture methods or targeted molecular detection methods. It improves the diagnosis and treatment level of difficult and rare infectious pathogens through the shotgun high-throughput sequencing to conduct unbiased and rapid detection of microorganisms in clinical samples, which has been widely recognized in clinical practice. Due to the complex detection process of mNGS, there are no uniform specifications and requirements at present. Meanwhile, most laboratories lack of relevant talents at the initial stage of platform establishment, which poses severe challenges to the construction and quality control of the mNGS platform. Based on the practical experience in the construction and operation of the mNGS laboratory of Peking Union Medical College Hospital, the current article summarizes the hardware requirements for the establishment of the mNGS laboratory, the establishment and evaluation methods of the mNGS testing system and the quality assurance after the clinical application, and comprehensively introduces the suggestions for the standardized construction and operation of the mNGS testing platform and quality management system.

早期诊断是防控感染性疾病的关键,病原宏基因组高通量测序(mNGS)技术突破了传统的培养方法或靶向分子检测手段的局限性,利用鸟枪法高通量测序技术对临床标本中的微生物进行无偏倚的快速检测,提升了疑难、罕见感染性病原体的诊疗水平,目前已经得到了临床的广泛认可。mNGS检测流程复杂,目前尚无统一的规范和要求,而多数实验室在建立平台初期缺乏相关人才的储备,致使mNGS平台建设和质量控制面临严峻挑战。本文从北京协和医院mNGS实验室本地化建设和运行过程中的实际经验出发,从建立mNGS实验室的硬件要求、mNGS检测体系的建立和评估方法以及mNGS临床应用后的质量保证三个方面进行概述,相对系统地介绍了mNGS检测平台和质量管理体系规范化建设和运行的建议。.

Publication types

  • English Abstract

MeSH terms

  • High-Throughput Nucleotide Sequencing*
  • Hospitals*
  • Humans
  • Laboratories
  • Metagenome
  • Quality Control
  • Sensitivity and Specificity