流感病毒抗原快速检测试剂灵敏度评价  

Evaluation on sensitivity of nine rapid influenza viral antigen diagnostic tests

作　　者：周海卫[1] 刘东来[1] 麻婷婷 许四宏[1] Zhou Haiwei;Liu Donglai;Ma Tingting;Xu Sihong(DivisionⅡof In Vitro Diagnostics for Infectious Diseases,Institute for In Vitro Diagnostics Control,National Institutes for Food and Drug Control,Beijing 100050,China)

机构地区：[1]中国食品药品检定研究院传染病诊断试剂二室,北京100050

出　　处：《中华实验和临床病毒学杂志》2020年第4期440-443,共4页Chinese Journal of Experimental and Clinical Virology

基　　金："十三五"国家科技重大专项(2018ZX10102001-004)。

摘　　要：目的对9种流感病毒抗原快速检测试剂盒(rapid influenza virus diagnostic tests,RIDTs)的灵敏度进行评价。方法季节性流感毒株收集后,通过TCID50(组织细胞半数感染量)和病毒核酸序列测定分别确定病毒滴度及型别;流感毒株进行系列稀释后,使用流感病毒抗原快速检测试剂盒进行检测,以评价不同试剂的灵敏度。结果不同试剂对同一株病毒的检出灵敏度差异最大为32倍稀释度(>10^1 TCID50/ml);同一种试剂对不同型别、亚型/系流感病毒的检出灵敏度不同。结论市场上的RIDTs灵敏度存在差别;使用多株不同流感型别、不同亚型/系的流感病毒将有助于对RIDTs产品质量进行全面评价和控制。Objective To evaluate the analytical sensitivity of nine rapid influenza virus antigen diagnostic tests(RIDTs).Methods Human seasonal influenza viruses were collected and amplified.Gene sequencing was performed and TCID50 were tested.Evaluation of nine RIDTs for the analytical sensitivity was performed after the subsequent dilution of human seasonal influenza A H3N2,H1N1,and influenza B viruses.Results RIDTs offers lower sensitivity than the nucleic acid amplification test.RIDTs overall had different analytical sensitivity based on the detection of the same isolate,and the difference between result was more than 101 TCID50/ml.Each RIDT had variable levels of positivity with different influenza subtypes/lineages.Conclusions The study demonstrated that the analytical sensitivity of RIDTs varies.

关 键 词：流感病毒 抗原快速检测试剂 灵敏度 

分 类 号：R446.6[医药卫生—诊断学]