冻干鼻喷流感减毒活疫苗病毒滴度FFA法的建立及验证  

Development and validation of FFA method for virus titer detection of freezedried nasal spray live attenuated influenza vaccine

作　　者：贾伟[1] 支百慧 韩玲 朱大永 王荣 张春 赵慧[3] 刘大维 JIA Wei;ZHI Baihui;HAN Ling;ZHU Dayong;WANG Rong;ZHANG Chun;ZHAO Hui;LIU Dawei(College of Life Science,Jilin Agricultural University,Changchun 130118,China)

机构地区：[1]吉林农业大学生命科学学院,长春130118 [2]长春百克生物科技股份公司,长春130012 [3]中国食品药品检定研究院,北京102629

出　　处：《中国免疫学杂志》2023年第7期1500-1506,共7页Chinese Journal of Immunology

基　　金：吉林省科技厅医药健康专项(20200708085YY)。

摘　　要：目的:建立并验证荧光灶法(FFA)检测冻干鼻喷流感减毒活疫苗病毒滴度的可行性。方法:采用FFA分别检测冻干鼻喷流感减毒活疫苗H1N1型、H3N2型、B型单一病毒收获液病毒滴度,并验证该方法的专属性、准确度、精密度、线性和耐用性。结果:该方法专属性良好;准确度回收率均为80%~115%,病毒滴度的试验内及试验间精密度RSD值均<10%;3个型别样品稀释倍数对数与病毒滴度呈线性关系,相关系数R2均>0.98;不同孵育温度的病毒滴度RSD值均<10%,耐用性良好。结论:建立的FFA具有良好的专属性、准确度、精密度、线性及耐用性,可用于冻干鼻喷流感减毒活疫苗病毒滴度检测。Objective:To establish and verify feasibility of fluorescent focus assay(FFA)as a titer detection method for freezedried nasall spraye live attenuated influenza vaccine.Methods:FFA was used to detect virus titers in harvesting fluid of freeze-dried nasal spray live attenuated influenza vaccine H1N1,H3N2 and B viruses.Specificity,accuracy,precision,linearity and durability of the method were verified.Results:The method has good specificity.Recovery rates of accuracy were 80%~115%.RSD values of virus titer for precision in inter-test and intra-test were all<10%.Dilution logarithm factor of three types of samples had a linear relationship with virus titer in which correlation coefficient R2 were all>0.98.RSD values of virus titer with incubation temperatures for robustness were all<10%.Conclusion:The developed FFA method has good specificity,accuracy,precision,linearity and robustness which can be used to detect virus titer of freeze-dried nasal spray live attenuated influenza vaccine.

关 键 词：流感病毒 冻干鼻喷流感减毒活疫苗 病毒滴度 FFA 

分 类 号：Q939.47[生物学—微生物学]