摘要
在美国,实验室自建方法(LDT)包括所有未经食品药品监督管理局(FDA)批准,以及FDA批准后又经过实质性修改的方法。被允许使用的LDT必须与FDA批准的方法具有相同的分析质量水平。在纽约州,LDT仅在经过严格的审查程序批准后才能用于临床样品的检测。通过对纽约州卫生厅审批的与临床质谱LDT方法学相关的一千多篇文献的查阅和分析,本研究总结了其中存在的主要问题,并对相关问题进行了解析,提出解决方案。这些问题主要来源于7个方面,包括色谱、内标、方法验证中所使用的样品基质、线性验证、基质效应、参考区间和室内质量控制。
In the United states,Laboratory Developed Test(LDT)include all non-FDA approved devices,and all FDA approved devices that have been substantially modified.LDTs are required to have the same analytical quality as FDA approved devices.In the State of New York,LDTs can only be used for testing clinical samples after being approved via a critical reviewing process.This article summarized main issues that were identified from reviewing over a thousand documents on LDT-mass spectrometry-based methodologies.These issues are presented in seven subtopics including chromatography,internal standard,sample matrix used in method validation,validation of linearity,validation for matrix effect,reference intervals and quality control.
作者
曹志民
周伟燕
Cao Zhimin Tim;Zhou Weiyan(Wadsworth Center,New York State Department of Health,Albany,NY,United States of America;China National Center for Clinical Laboratories,Beijing Engineering Research Center of Laboratory Medicine,Beijing Hospital,National Center of Gerontology,Institute of Geriatric Medicine,Chinese Academy of Medical Sciences,Beijing 100730,China)
出处
《中华检验医学杂志》
CAS
CSCD
北大核心
2020年第12期1160-1165,共6页
Chinese Journal of Laboratory Medicine
关键词
实验室自建方法
液相色谱
质谱
方法验证
Laboratory Developed Test
Liquid chromatography
Mass spectrometry
Method validation
