摘要
高通量基因测序技术,即下一代测序(NGS)在血液肿瘤的筛查、诊断分型、治疗指导,预后分层、微小残留病监测和复发预测有着重要临床应用价值。虽然已有众多国内外诊疗指南推荐,血液肿瘤NGS的临床应用仍处于初期阶段。加强NGS实验流程的质量管理是保证技术正确应用的重要环节。NGS技术原理和实验流程复杂,实现高质量的临床检测对"人、机、料、法、环"等质量管理要素的系统管理要求高。本文基于NGS在血液肿瘤临床应用中的质量管理要素现状提出见解,并做以展望,以期为血液肿瘤NGS临床应用的规范化起到正向作用。
High-throughput sequencing technology(NGS)has important clinical applications in screening,disease classification,clinical management,prognostic stratification,minimal residual disease monitoring and relapse prediction in hematological malignancies.Although there are many domestic and international guidelines have been recommended,the clinical application of NGS in hematological malignancies is still in the early stage.Strengthening the quality management of the NGS experimental process is an important part of ensuring the correct application of this technology.The technical principles and experimental procedures of NGS are complex,and the implementation of high-quality clinical testing has high requirements for the systematic management of quality management elements such as"human,machine,material,method,and environment".This article proposes insights and prospects based on the status of quality management elements of NGS in the clinical application of hematological malignancies,hoping to play a positive role in the standardization of clinical applications of NGS in hematological malignancies.
作者
吴祁生
王芳
聂代静
周晓苏
陈佳琦
刘红星
WU Qisheng;WANG Fang;NIE Daijing;ZHOU Xiaosu;CHEN Jiaqi;LIU Hongxing(Department of Pathology and Laboratory Medicine,Beijing Ludaopei Hospital,Beijing 100176,China;Department of Pathology and Laboratory Medicine,Hebei Yanda Ludaopei Hospital,Langfang 065201,China;Beijing Ludaopei Institute of Hematology,Beijing 100176,China)
出处
《分子诊断与治疗杂志》
2021年第5期845-848,共4页
Journal of Molecular Diagnostics and Therapy
基金
河北省医学科学研究课题(20210022)。
关键词
高通量基因测序技术
血液肿瘤
临床应用
质量管理
High-throughput sequencing technology
Hematological malignancies
Clinical applications
Quality management
作者简介
通信作者:刘红星,E⁃mail:starliu@pku.edu.cn。
