实验室自制试剂(laboratory-developed test,LDT)是指由实验室内部开发使用、不需要经过商业注册的体外诊断试剂(in vitro diagnostic medical devices,IVDs).自制试剂涉及技术广泛,如高通量测序技术、质谱技术、流式细胞分析技术等,能够结合基因组学、转录组学、蛋白质组学、代谢组学等多种组学技术,成为研究遗传病生理病理机制的重要技术方法.中日友好医院被指定为我国10家自行研制使用体外诊断试剂的试点医疗机构之一,率先开展多组学自制试剂实验室建设.本文对医疗机构建设多组学自制试剂实验室的必要性、建设实践和运行风险等进行阐述.
Practice and Reflections on the Construction of Multi-Omic Developed Test Laboratory in Medical Institutions
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.
medical institutionmulti-omicslaboratory-developed testin vitro diagnostic medical devicesregulation
万方数据
维普
