摘要
目前,遗传病筛查和检测主要采用实验室自建项目(LDT)和商品化体外诊断(IVD)产品2种形式,但国内外在2种形式上略有差异。文章梳理了遗传病检测相关行业进展,介绍中国和美国在相关政策上的差异,并对未来发展趋势进行展望。
Currently,genetic disease screening and testing mainly rely on 2 forms of operation,laboratory developed test(LDT)and in vitro diagnostics(IVD),with slight differences in operation between countries.This review focuses on summarizing the progress of genetic disease testing in the industry and the policy support differences between China and the United States of America,and provides an outlook on the future development trends.
作者
江鸿
宋婕萍
李胜
JIANG Hong;SONG Jieping;LI Sheng(The Affiliated Maternity and Children's Health Hospital of Hubei Polytechnic University,Huangshi Maternity and Children's Health Hospital,Children's Hospital of Huangshi City,Neonatal Diseases Screening Center/Birth Defects Prevention Center of Huangshi City,Huangshi 435099,Hubei,China;Medical Genetic Center,Hubei Provincial Maternal and Child Health Hospital,Wuhan 430070,Hubei,China)
出处
《检验医学》
CAS
2024年第2期114-119,共6页
Laboratory Medicine
基金
湖北省科技重点研发计划大健康项目(2022BCE037)
2022年度湖北省自然科学基金创新发展联合基金项目(2022CFD070)
湖北理工学院校级科研项目(21xjz08Y)
黄石市妇幼保健院2022—2023年度院级科研项目青年项目(HSMCHH2022003)。
关键词
实验室自建项目
体外诊断
遗传病
中国
美国
Laboratory developed test
In vitro diagnostics
Genetic disease
China
The United States of America
