摘要
目的对3种SARS-CoV-2 mRNA疫苗免疫血清抗体水平的检测方法进行比较。方法分别采用酶联免疫吸附试验(enzyme-linked immunosorbent assay,ELISA)、假病毒中和试验(pseudo virus-based neutralization assay,PBNA)及微量细胞病变中和试验(micro-cytopathic effect neutralization test,MCPENT)检测SARS-CoV-2 mRNA疫苗免疫前及2针免疫后共120份血清(免疫前40份,免疫后80份)的抗体水平,分析3种检测方法的一致性和相关性。结果3种方法检测120份血清的符合率均达90%以上,Kappa系数均>0.7,P均<0.01。3种方法检测阳性血清抗体滴度结果的相关系数(r)为0.825~0.902,P均<0.01。结论3种方法用于SARS-CoV-2 mRNA疫苗免疫血清抗体水平检测具有良好的一致性及相关性。
Objective To compare three methods for detection of antibody level in serum immunized with SARS-CoV-2 mRNA vaccine.Methods Enzyme-linked immunosorbent assay(ELISA),pseudo virus-based neutralization assay(PBNA)and micro-cytopathic effect neutralization test(MCPENT)were used to detect the antibody levels of a total of 120 serum samples(40 before immunization and 80 after immunization)before and after 2 doses of mRNA vaccine immunization,and the consistency and correlation of the three methods were analyzed.Results The consistency rates of the three methods detecting 120 serum samples were all over 90%,the Kappa coefficients were all more than 0.7,and each P was less than O.01.The correlation coefficient(r)between the antibody potency results of positive serum samples detected by the three methods was 0.825~0.902,and each P was less than 0.01.Conclusion The three methods have good consistency and correlation in detecting antibody level of serum immunized with SARS-CoV-2 mRNA vaccine.
作者
吴小红
赵丹华
刘欣玉
杨立宏
李玉华
曹守春
WU Xiaohong;ZHAO Danhua;LIU Xinyu;YANG Lihong;LI Yuhua;CAO Shouchun(Division of Arbovirus Vaccine,National Institutes for Food and Drug Control,Beijing 102629,China)
出处
《中国生物制品学杂志》
CAS
CSCD
北大核心
2023年第12期1414-1418,共5页
Chinese Journal of Biologicals
基金
国家重点研发计划(2021YFC2302404)。
关键词
酶联免疫吸附试验
假病毒中和试验
微量细胞病变中和试验
SARS-CoV-2
mRNA疫苗
Enzyme-linked immunosorbent assay(ELISA)
Pseudo virus-based neutralization assay(PBNA)
Micro-cytopathic effect neutralization test(MCPENT)
SARS-CoV-2
mRNA vaccine