摘要
近年来,遗传检测技术发展迅速,但随之也产生很多问题。遗传检测技术在应用于临床或直接面对顾客之前都必须进行全面的卫生技术评估。介绍了美国相关部门制定的遗传检测评估ACCE框架,主要包括四大方面内容:分析有效性,临床有效性,临床实用性,伦理、法律、社会诸多要素四个方面,以及四个方面具体的评估参数,评估贯穿全程,同时需要多部门分工协作。ACCE评估框架考虑了多方面的因素,为遗传检测的评估提供了一个全方位的框架,为我国相关政策的制定提供了参考。
In recent years, genetic testing technology has developed rapidly, but with a lot of problems.Before genetic testing technology in the application of clinical or direct face to customers need a comprehensive health technology assessment.This paper introduces the ACCE framework of genetic testing and evaluation, which includes four aspects： analytic validity, clinical validity, clinical utility, ethical, legal, and social implications.As well as four aspects of specific assessment Parameters, assessment throughout the whole process, while the need for multi-sectoral division of labor.The ACCE evaluation framework considers a wide range of factors, providing a comprehensive framework for the assessment of genetic testing, providing a reference for the development of relevant policies in China.
作者
邹明明
赵明杰
ZOU Ming-ming ZHAO Ming-jie(Press of Journal, Dalian Medical University, Dalian 116044, China)
出处
《医学与哲学（B）》
2017年第8期27-31,共5页
Medicine & Philosophy(B)
基金
2017年辽宁省教育科学"十三五"规划课题(JG17DB138)
关键词
遗传检测
卫生技术评估
临床有效性
分析有效性
genetic testing
health technology assessment
clinical validity
analytic validity
