摘要
目的:组织不同的实验室分析假病毒中和法(Pseudo Virus-based Neutralization Assay,PBNA)对不同样品的狂犬病病毒中和抗体水平的检测能力,并比较其与经典的快速免疫荧光灶抑制试验(Rapid Fluorescent Focus Inhibition Test,RFFIT)以及小鼠中和试验法(Mouse Neutralization Test,MNT)的相关性。方法:共9家实验室,分别采用PBNA、RFFIT以及MNT法对6份样品进行狂犬病病毒中和抗体检测,每个实验室进行3~5次重复实验。采用配对t检验及Pearson相关系数对3种检测方法的结果进行统计学分析。结果:PBNA与RFFIT、PBNA与MNT、RFFIT与MNT Pearson相关系数分别为0.985、0.988和0.974,抗体几何平均滴度进行t检验,差异均无统计学意义(P>0.05)。结论:3种方法重复检测6份样品的定量结果具有高度的相关性,PBNA法可作为《中华人民共和国药典》方法RFFIT、MNT的一种替代或补充方法,用于人用狂犬病疫苗临床血清、狂犬病人免疫球蛋白及抗狂犬病血清的狂犬病病毒中和抗体效价检测。
Objective:To analyze the ability of pseudo virus-based neutralization assay(PBNA)to detect rabies virus neutralization antibody levels in different samples in different laboratories,and compare its correlation with classic rapid fl uorescent focus inhibition test(RFFIT)and mouse neutralization test(MNT).Methods:A total of 9 laboratories were used to test rabies virus neutralization antibody in 6 samples by PBNA,RFFIT and MNT methods respectively,and 3 to 5 repeated experiments were carried out in each laboratory.Paired t test and Pearson correlation coeffi cient were used to analyze the results of the three detection methods.Results:The Pearson correlation coeffi cient between PBNA and RFFIT,PBNA and MNT,RFFIT and MNT were 0.985,0.988 and 0.974 separately.The geometric mean titer of antibody was tested by t test,and there was no significant diff erence(P>0.05).Conclusion:The quantitative results of the repeated detection of 6 samples by three methods are highly correlated.PBNA method can be used as a substitute or supplementary method for RFFIT and MNT methods in Chinese Pharmacopoeia for the detection of rabies virus neutralization antibody in clinical serum of human rabies vaccine,rabies human immunoglobulin and anti-rabies serum.
作者
吴小红
赵丹华
丁如霞
李玉华
聂建辉
Wu Xiaohong;Zhao Danhua;Ding Ruxia;Li Yuhua;Nie Jianhui(National Institutes for Food and Drug Control,Beijing 102629,China)
出处
《中国药事》
CAS
2024年第2期210-216,共7页
Chinese Pharmaceutical Affairs
基金
国家药品标准提高课题(编号2019S005)。
关键词
假病毒中和试验
免疫荧光灶抑制试验
小鼠中和试验法
狂犬病毒中和抗体
协作研究
pseudo virus-based neutralization assay
rapid fl uorescent focus inhibition test
mouse neutralization test
rabies virus neutralization antibody
collaborative study
