Evaluation on the accuracy of functional antibody detection technology for 13 valent pneumococcal vaccine
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
Abstract：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 laboratorieswith 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 DrugAdministration (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 rc 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.
[1] 中华预防医学会,中华预防医学会疫苗与免疫分会.肺炎球菌性疾病免疫预防专家共识(2020版)[J].中华流行病学杂志,2020,41(12):1945-1979. [2] 王娟,谢良伊,张景,等.2013—2017 年某院呼吸道分离病原菌分布及耐药性分析[J].实用预防医学,2020,27(5):584-588. [3] 汪洋,向左云,任江伟,等.肺炎球菌结合疫苗的研究现状及前景[J].中国生物制品学杂志,2022,35(9):1025-1033. [4] 杨红涛,袁敏学.新一代广谱肺炎链球菌疫苗的研究进展[J].中国生物制品学杂志,2022,35(5):608-614. [5] Song JY, Moseley MA, Burton RL, et al.Pneumococcal vaccine and opsonic pneumococcal antibody[J].J Infect Chemother,2013,19(3):412-425. [6] Burton RL,Nahm MH. Development and validation of a fourfold multiplexed opsonization assay (MOPA4) for pneumococcal antibodies[J].Clin Vaccine Immunol, 2006,13(9):1004-1009. [7] Rose CE,Romero-Steiner S,Burton RL,et al. Multilaboratory comparison of Streptococcus pneumonia opsonophagocytic killing assays and their level of agreement for the determination of functional antibody activity in human reference sera[J].Clin Vaccine Immunol, 2011,18(1):135-142. [8] Romero-Steiner S, Frasch C, Concepcion N, et al. Multilaboratory evaluation of a viability assay for measurement of opsonophagocytic antibodies specific to the capsular polysaccharides of Streptococcus pneumonia[J].Clin Diagn Lab Immunol, 2003,10(6):1019-1024. [9] Burton RL, Antonello J, Cooper D, et al. Assignment of opsonic values to pneumococcal reference serum 007sp for use in opsonophagocytic assays for 13 serotypes[J].Clin Vaccine Immunol, 2017,24(2):e00457-16. [10] 李江姣,杜慧竟,石继春,等. 评价肺炎链球菌疫苗免疫效果的功能性抗体检测方法的建立[J].中国医药导报,2014,11(20):4-8. [11] 李江姣,杜慧竟,陈驰,等.肺炎球菌结合疫苗两种免疫效果评价方法的比较分析[J].实用预防医学,2014,21(11):1281-1284. [12] 李江姣,杜慧竟,石继春,等.多重调理吞噬试验方法的重复性和再现性研究[J].中国医药导报,2015,12(28):14-17. [13] 黄洋,徐潇,李康,等.检测肺炎球菌疫苗功能性抗体的标准株分子特征分析[J].中华实验和临床病毒学杂志,2021,35(5):509-513. [14] 杜慧竟,张全仓,李江姣,等.全自动移液工作站在肺炎疫苗多重调理吞噬实验中的应用[J].中国生物制品学杂志,2022,35(2):194-199. [15] Lin LI. A concordance correlation coefficient to evaluate reproducibility[J].Biometrics, 1989,45(1):255-268.
2023, Vol. 30 
