【摘要】 以质谱技术、流式细胞术及二代测序技术为代表的实验室自建项目(laboratory developed test,LDT)已在临床检测中普遍应用,并在临床诊断、治疗及健康管理中发挥重要作用。我国LDT面临涉及领域广、技术平台多、仪器设备复杂、影响因素多,且检测方法难以溯源到参考方法或参考物质等问题,临床实验室应遵循项目研发、项目投入临床检测前确认、项目投入临床检测后质量监管的流程,做好LDT质量管理,保证检测结果的准确可靠。更多还原

【Abstract】 Laboratory developed test(LDT) utilizing advanced techniques such as mass spectrometry, flow cytometry and next-generation sequencing technology has been widely used in clinical tests and plays important roles in clinical diagnosis, treatments and healthcare managements. Currently, there are many challenges in LDT area. These challenges include a wide range of fields, different technological platforms, complex instruments variable diagnostic approaches, difficulty of tracing back to reference methods or materials. In order to ensure the quality and accuracy of LDT, laboratories should follow a series of processes including supervising new project research and development before and after clinical tests.更多还原