【作者】 毛群颖； 郭增兵； 郝春生； 于丹； 李秀玲； 梁争论；

【Author】 MAO Qun-ying1,GUO Zeng-bing2,HAO Chun-sheng3,YU Dan4,LI Xiu-ling3,LIANG Zheng-lun1

【机构】 中国食品药品检定研究院； 华兰生物工程股份有限公司研发部； 北京生物制品研究所； 北京科兴生物制品有限公司；

【摘要】 目的:研制1批EV71疫苗中和试验检测标准病毒候选株,用于EV71中和抗体检测的标准化。方法:采用冷冻干燥方法,按《中国药典》相关要求制备符合我国疾病流行特征的检测用标准病毒1批。联合国内3家EV71检测实验室,采用经典细胞病变法和相同的操作程序对该批病毒的病毒滴度进行协作测定,并在实验室A和B与中和抗体标准品共同应用,检测17份人血清样品的中和抗体含量。结果:病毒滴度为4.83 lgCCID₅₀/mL,稳定性良好。其他项目均达到国家标准品要求。结论:第一批候选C4型EV71标准病毒株与中和抗体标准品联合应用可有效控制EV71中和抗体检测的准确性和可比性,可进一步扩大应用,为C4型EV71标准病毒株的建立奠定基础。更多还原

【Abstract】 Objective:One batch of standard virus candidate strain used in enterovirus 71（EV71） neutralization antibody determination was developed and used to standardize the determination of EV71 neutralizing antibodies.Methods: Using freeze-drying method,one batch of standard virus candidate strain that conforms to the epidemic characteristics of China was prepared according to requirements of "Chinese Pharmacopoeia".Standard virus candidate strain was cooperatively titrated in 3 assigned independent laboratories by using classic cytopathic method and the same operating procedures.In addition,EV71 neutralization antibody（NTAb） contents of 17 human serum samples were tested using standard virus candidate strain and NTAb serum standards in A laboratory and B laboratory.Results:This standard virus candidate strain titer was 4.83 lgCCID₅₀ /mL and has good stability.Other items all meet with the requirements of national reference standards.Conclusion:Joint application of the first batch of standard virus candidate strain for human EV71 genogroup C4 virus and neutralization antibody reference standards can effectively control accuracy and comparability of EV71 neutralization antibody determination.This application could be further expanded and lay the foundation for establishment of human EV71 genogroup C4 reference standard virus.更多还原