中国食品药品监管Issue(3)：28-33,6.DOI:10.3969/j.issn.1673-5390.2024.03.003
医疗机构多组学自制试剂实验室的建设实践与思考
Practice and Reflections on the Construction of Multi-Omic Developed Test Laboratory in Medical Institutions
摘要
Abstract
Laboratory-developed test(LDT)refers to in vitro diagnostic medical devices(IVDs)developed and used internally within the laboratory,requiring no commercial registration.LDTs involve a wide range of technologies such as high-throughput sequencing,mass spectrometry,flow cytometry,and bring together various omics technologies such as genomics,transcriptomics,proteomics,and metabolomics.They have become an important technical approach for understanding the pathophysiological mechanisms of genetic diseases.China-Japan Friendship Hospital,designated as one of the ten pilot medical institutions for LDTs in China,has taken the lead in constructing a laboratory for multi-omics LDTs.This article elaborates on the necessity,practices,and operational risks of building a laboratory for multi-omics LDTs in a medical institution.关键词
医疗机构/多组学/实验室自制试剂/体外诊断试剂/监管Key words
medical institution/multi-omics/laboratory-developed test/in vitro diagnostic medical devices/regulation分类
医药卫生引用本文复制引用
邬巧玲,崔勇,赵建康,贾红兵,陈皇,高芃,张瑞苹,郗雅琪,杨瑞,阳玥..医疗机构多组学自制试剂实验室的建设实践与思考[J].中国食品药品监管,2024,(3):28-33,6.基金项目
中日友好医院高水平医院临床业务费专项临床研究项目(2023-NHLHCRF-GLMS-30) （2023-NHLHCRF-GLMS-30）
