重组结核分枝杆菌变态反应原皮肤试验用制剂命名探讨

Discussion on the nomenclature of recombinant Mycobacterium tuberculosis allergen skin test

针对世界卫生组织于2022年推荐的结核感染检测新方法,基于结核分枝杆菌抗原检测结核分枝杆菌感染的皮肤试验检测技术(MTB antigen-based skin tests,TBST),作者对已上市与在研同类新品种的命名情况进行梳理,参考中国生物制品命名相关原则,对该类产品命名进行探讨,供研发、使用和监管部门的专家讨论参考。

In view of the new tuberculosis infection test recommended by WHO in 2022,the MTB antigen-based skin tests(TBST)for the diagnosis of tuberculosis infection,the authors sorted out the name of new varieties of the same kind that have been listed and are under research,discussed the nomenclature of such products with reference to the principles related to nomenclature of biological products in China,expected to provide discussion and reference for experts from research and development,use and regulatory departments.