首页|假病毒中和试验对狂犬病毒中和抗体效价的检测效能分析

假病毒中和试验对狂犬病毒中和抗体效价的检测效能分析

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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.
Study on the Pseudo Virus-based Neutralization Assay for Rabies Virus Neutralization Antibody Test
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 fluorescent 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 coefficient were used to analyze the results of the three detection methods.Results:The Pearson correlation coefficient 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 difference(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.

pseudo virus-based neutralization assayrapid fluorescent focus inhibition testmouse neutralization testrabies virus neutralization antibodycollaborative study

吴小红、赵丹华、丁如霞、李玉华、聂建辉

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中国食品药品检定研究院,北京 102629

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

国家药品标准提高课题

2019S005

2024

中国药事
中国食品药品检定研究院(中国药品生物制品检定所)

中国药事

CSTPCD
影响因子:0.844
ISSN:1002-7777
年,卷(期):2024.38(2)
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