Zhonghua Yi Xue Za Zhi. 2024 Dec 24;104(48):4375-4383. doi: 10.3760/cma.j.cn112137-20240927-02208.
Targeted next-generation sequencing (tNGS) technology focuses on detecting pathogenic microorganisms and drug-resistant genes in clinical samples by designing specific primers or capture probes, providing evidence for the diagnosis, treatment and surveillance of infectious diseases. However, the current clinical application scenarios of tNGS and metagenomic next-generation sequencing (mNGS) are not clearly defined, and the tNGS systems from different manufacturers vary significantly in quality and results. There is an urgent need for consensus and standards regarding the clinical indications, laboratory processes, quality control, performance validation and interpretation of reports for this technology. In order to standardize the application and practice of tNGS in infectious diseases, experts in the fields of microbiology, infectious disease, respiratory disease, epidemiology and other fields from the Society of Clinical Microbiology of China International Exchange and Promotion Association for Medical and Healthcare discussed the above problems, wrote the expert consensus on the application and practice of tNGS in infectious diseases. This consensus summarizes the research on tNGS in infectious diseases, and proposes recommendations that are in line with clinical practice in China, so as to standardize the application and practice of tNGS in infectious diseases. The main contents include: consensus formulation process, clinical indications, technical points, wet and dry experiments, report and interpretation, and report template.
靶向二代测序（tNGS）技术通过设计特异性引物或捕获探针，专注于检测临床样本中的致病微生物和耐药基因，为传染病的诊断、治疗及监测提供依据。然而，目前tNGS与宏基因组二代测序（mNGS）的临床应用场景尚不明确，不同厂家的tNGS系统在质量和结果上差异显著。对于该技术的临床适应证、实验室流程、质量控制、性能验证及报告解读，迫切需要达成共识并制定标准。为规范tNGS在传染病中的应用与实践，中国国际医疗保健交流促进会临床微生物学会的微生物学、传染病学、呼吸病学、流行病学等领域的专家对上述问题进行了讨论，撰写了tNGS在传染病中应用与实践的专家共识。本共识总结了tNGS在传染病方面的研究，并提出符合中国临床实践的建议，以规范tNGS在传染病中的应用与实践。主要内容包括：共识制定过程、临床适应证、技术要点、湿实验与干实验、报告与解读以及报告模板。
