国外实验室自建项目管理带给我们的启示  

Enlightenment from the management of laboratory developed test in foreign laboratory

作　　者：刘维薇[1,2] 郑特[1] 徐科[1] 关明[3] 

机构地区：[1]同济大学附属上海市第十人民医院检验科,200072 [2]上海市皮肤病医院检验科 [3]复旦大学附属华山医院检验科

出　　处：《中华临床实验室管理电子杂志》2014年第3期1-4,共4页Chinese Journal of Clinical Laboratory Management(Electronic Edition）

基　　金：上海市卫生局优秀学科带头人计划资助项目(XBR2011044);上海市卫生局优秀青年人才培育计划(XYQ2013095);上海申康医院发展中心辅助科室能力建设项目(SHDC22014006)

摘　　要：实验室自建项目(laboratory developed tests,LDTs)在个体化诊断中发挥越来越重要的作用,同时也变得越来越复杂,风险很高,存在的问题和隐患亟待解决。国外,尤其是美国对LDTs的监管经历了几十年演变,逐步认识并强调监管的重要性,进一步规范各项监管措施。我国目前虽未允许LDTs在临床应用,但临床转化指日可待。理想的监管模式应该包括公正的、基于风险管理的监管方案、逐步监管、能力验证、临床有效性和实用性以及紧急使用授权规定等多个方面。LDTs是检验医学发展的一次机遇,应逐步建立并完善。Laboratory developed tests （LDTs） are playing an increasingly important role in personalized medicine; however, it is also becoming more complex, high-risk, and full of problems and pitfalls to be solved. The regulation of LDTs have been captured much more attention in foreign countries, especially in the United State, after its decades of evolution, and newly rules are draw up. The clinical applications of LDTs are just around the comer in China, even though it is not qualified currently. An ideal model of regulation should include fairness, risk-based regulatory program, gradually supervision, proficiency testing, clinical effectiveness and practicality as well as Emergency Use Authorization. LDTs provide an oppomanity not only for developing laboratory medicine but also for bettering the clinical service; while the quality control and management system of LDTs should be established and improved gradually.

关 键 词：实验室自建项目 监管 医学实验室 

分 类 号：R197.3[医药卫生—卫生事业管理]