13价肺炎链球菌疫苗功能抗体检测技术的准确性评估  

Evaluation on the accuracy of functional antibody detection technology for 13 valent pneumococcal vaccine

作　　者：李江姣[1] 李康[1] 黄洋[1] 徐潇[1] 杜慧竟[1] 叶强[1] LI Jiangjiao;LI Kang;HUANG Yang;XU Xiao;DU Huijing;YE Qiang(NHC Key Laboratory of Research on Quality and Standardization of Biotech Products,NMPA Key Laboratory for Quality Research and Evaluation of Biological Products,National Institutes for Food and Drug Control,Beijing 102629,China)

机构地区：[1]中国食品药品检定研究院,国家卫生健康委员会生物技术产品检定方法及其标准化重点实验室,国家药品监督管理局生物制品质量研究与评价重点实验室,北京102629

出　　处：《实用预防医学》2023年第10期1176-1179,共4页Practical Preventive Medicine

基　　金：国家科技资源共享服务平台资助(国家病原微生物资源库-NPRC-32);国家科技重大专项课题(2018ZX09738006-006)

摘　　要：目的对13价肺炎链球菌疫苗功能抗体检测技术即多型调理吞噬技术(multiplexed opsonophagocytic killing assay,MOPA)进行准确性评估,并为建立该技术的其他实验室提供参考。方法利用建立的MOPA方法对美国食品及药品管理局的16份参考血清盘进行13个血清型(分别为1、3、4、5、6A、6B、7F、9V、14、18C、19A、19F和23F型)的调理吞噬试验(opsonophagocytic killing assay,OPKA)滴度检测,将检测值与其各血清型的定值进行比较分析。结果皮尔逊相关系数统计结果显示,各血清型的r值范围为0.90~0.98,平均为0.94。林氏一致性相关系数分析结果显示,13种血清型的r_(c)值范围为0.88~0.98,平均为0.92。对于所检测的13个血清型,处于各型定值上下2倍范围内的数据比率为75%~100%,平均为92%;处于各型定值上下3倍范围内的数据比率为94%~100%,平均为98%。16份参考血清盘的13个血清型的OPA滴度检测结果与其各型定值具有良好的相关性和一致性。结论本研究表明该室建立的MOPA方法具有良好的准确性,可用于肺炎链球菌疫苗的临床免疫原性评价。Objective To assess the accuracy of functional antibody detection technology,namely,multiplex opsonophagocytic killing assay(MOPA)for 13 valent pneumococcal vaccine,and to provide references for other laboratories with this technology.Methods The established MOPA method was used to detect the opsonophagocytic killing assay(OPKA)titers of antibodies against pneumococcal serotypes 1,3,4,5,6A,6B,7F,9V,14,18C,19A,19F and 23F in 16 Food and Drug Administration(FDA)reference sera,and the detection data were compared with the consensus values of each serotype.Results Pearson correlation coefficient analysis revealed that r values of the 13 serotypes ranged from 0.90 to 0.98,with an average of 0.94.Lin’s concordance correlation coefficient analysis displayed that r_(c) values of the 13 serotypes ranged from 0.88 to 0.98,with an average of 0.92.For the 13 serotypes detected,the percentages of results within±2-fold of the consensus values for the 16 serum samples were 75%-100%,with an average of 92%.The percentages of results within±3-fold of the consensus values were 94%-100%,with an average of 98%.The OPFA titers of antibodies against the 13 serotypes in the 16 reference sera were highly correlated and consistent with their assignments.Conclusion This study shows that the MOPA method established in the laboratory has good accuracy and can be used for the clinical immunogenicity evaluation of pneumococcal vaccines.

关 键 词：肺炎链球菌 疫苗 功能抗体 调理吞噬试验 准确性 

分 类 号：R186[医药卫生—流行病学]