甲型H1N1流感病毒核酸检测试剂比较.pdf

文档介绍：基金项目:科技部甲型 H1N1 流感联防控应急科研项目( 2009BAKYJ002 ) . 通讯作者:王军志, E-mail : ******@.cn 甲型 H1N1 流感病毒核酸检测试剂比较范行良 1 李长贵 1 高荣宝 2 邱平 1 邵铭 1 秦成峰 3 王军志 1 1. 中国药品生物制品检定所 2. 国家疾病预防控制中心病毒病研究所 3. 军事医学科学院微生物流行病研究所目的为应对甲型 H1N1 流感突发疫情,筛选适宜的甲型 H1N1 流感病毒核酸检测试剂盒。方法制备评价性参考品盲样并对甲型 H1N1 流感病毒核酸检测试剂进行评价。参考品由阳性参考品、阴性参考品和最低检出限参考品组成。通过对 33 种甲型 H1N1 流感病毒核酸检测试剂盲样检测结果进行盲评,筛选出入围产品;然后对入围的参评试剂进行统一测评,对检测试剂性能进行确认。结果筛选出 7种试定量荧光 PCR 试剂和 1种基因芯片试剂。结论定量荧光 PCR 方法灵敏度高、特异性好,结果可靠。关键词甲型 H1N1 流感病毒 parison of Influenza H1N1 vi rus Nucleic Acid Detection Kits Fan Xingliang 1 , Li Changgui 1, Gao Rongbao 2, Qiu Ping 1 , Shao Ming 1 , Qin Chengfeng 3, Wang Junzhi 1 1. National Institute for the Control of Pharmaceutical and Biological Products, 2. Institue for Viral Disease Control and Prevention, China CDC 3. Institute of Microbiology and Epidemiology ,Academy of Military Medical 【 Abstract 】 OBJECTIVE To find out the appropriate detection methods for influenza H1N1virus, the detection ability evaluation was made. METHOD Three strains of Influenza H1N1virus and seven kinds other virus were prepared and validated. The evaluation Panel was established, in which the positive samples, negative samples and Lowest Detection Level samples were prepared. The evaluation of 33 kinds nucleic acid detection kits was made by manufactures and three national laboratories individually. All the samples were random and double-blind.