甲型、乙型流感病毒核酸检测试剂盒的质量评价  

Evaluation of Quality Control for RT-PCR Kits in Detection of Influenza A and B Virus

作　　者：李杨霞 陈文铎 朱晓云 王鹏[1] 周林福[1] LI Yang-xia;CHEN Wen-duo;ZHU Xiao-yun;WANG Peng;ZHOU Lin-fu(School of Medicine of Zhejiang University,Zhejiang Hangzhou 310000)

机构地区：[1]浙江大学医学院,浙江杭州310000

出　　处：《中国医疗器械信息》2020年第9期23-24,共2页China Medical Device Information

摘　　要：目的:对2种国产甲型、乙型流感病毒核酸联合检测试剂盒进行质量评估。方法:应用甲/乙型流感病毒核酸检测试剂国家参考品和临床样本,按照各自试剂盒说明书方法进行检测。结果:2种试剂盒特异性、最低检出限及精密度均符合国家参考品要求。2种试剂盒临床样本检测一致性好。结论:2种甲型、乙型流感病毒核酸联合检测试剂盒性能可靠,具有临床应用价值。Objective:To evaluate 2 kinds of domestic RT-PCR kit for detection Influenza A and B virus.Methods:The kits were applied to detect the national reference panel of Influenza A and B virus and clinical samples.Results:The detected kits meet the national standards and show good consistence in clinical samples test.Conclusion:The two kinds of influenza A and B virus nucleic acid combined detection kits have reliable performance and clinical application value.

关 键 词：甲型流感病毒 乙型流感病毒 实时PCR 

分 类 号：TH776[机械工程—仪器科学与技术]