中国防痨杂志2018，Vol.40Issue(1)：17-19,3.DOI:10.3969/j.issn.1000-6621.2018.01.006
结核分枝杆菌抗体检测试剂及相关问题的探讨
Discussion on the problems related to Mycobacterium tuberculosis antibody detection reagents
刘容枝1
作者信息
- 1. 100081北京,国家食品药品监督管理局医疗器械技术审评中心
- 折叠
摘要
Abstract
The role of Mycobacterium tuberculosis antibody detection reagents in the diagnosis of tuberculosis has been involved in the related guidelines.The application of Mycobacterium tuberculosis antibody detection reagents in clinic has been questioned by the World Health Organization (WHO).This paper analyzes the current status of the registration of Mycobacterium tuberculosis antibody detection reagents in China and the possible reasons.Meanwhile,we expound the key issues of main raw materials,performance analysis and clinical trial in the registration and declaration of Mycobacterium tuberculosis antibody detection reagents.关键词
分枝杆菌,结核/抗体/试剂盒,诊断/临床试验/基于问题的学习Key words
Mycobacterium tuberculosis/Antibodies/Reagent kits, diagnostic/Clinical trial/Problem-based learning引用本文复制引用
刘容枝..结核分枝杆菌抗体检测试剂及相关问题的探讨[J].中国防痨杂志,2018,40(1):17-19,3.
