摘要
探讨了生殖道病原体核酸检测试剂分析性能评估的要点,阐述了产品临床前研究需要重点考虑的因素。并以高危型人乳头瘤病毒检测试剂以及沙眼衣原体和/或淋病奈瑟菌检测试剂为例进行了说明,包括企业参考品的设置等。
Discuss specific consideration when develop plans for analytical performances for genital tract pathogen nucleic acid detection reagent.Besides,we take high risk human papillomavirus,chlamydia trachomatis and Neisseria gonorrhoeae nucleic acid detection reagents for example.
作者
包雯
BAO Wen(Center for Medical Device Evaluation.NMPA,Beijing 100081)
出处
《中国医疗器械信息》
2020年第17期16-17,64,共3页
China Medical Device Information
关键词
泌尿生殖道感染
高危型人乳头瘤病毒检测试剂
沙眼衣原体和
或淋病奈瑟菌检测试剂
企业参考品
infection of genital tract
high risk human papillomavirus nucleic acid detection reagents
chlamydia trachomatis and neisseria gonorrhoeae nucleic acid detection reagents
enterprise internal reference
