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

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.