新型冠状病毒中和抗体与特异性抗体检测结果一致性分析  

Comparison of SARS-CoV-2 neutralizing antibody and specific antibody determination results

作　　者：肖秀美[1] 梁超 刘彩红[2] 李晓光[2] XIAO Xiumei;LIANG Chao;LIU Caihong;LI Xiaoguang(Department of Clinical Laboratory,Peking University Third Hospital,Beijing 100191,China;Department of Infectious Diseases,Peking University Third Hospital,Beijing 100191,China)

机构地区：[1]北京大学第三医院检验科,北京100191 [2]北京大学第三医院感染疾病科,北京100191

出　　处：《检验医学》2023年第4期352-356,共5页Laboratory Medicine

基　　金：科技部重大专项基金资助项目(2018ZX10732401-003)。

摘　　要：目的探讨新型冠状病毒(SARS-CoV-2)中和抗体与特异性IgM、IgG抗体的一致性,为疫苗接种人群特异性抗体检测结果的临床解读提供依据。方法选取排除SARS-CoV-2感染的健康医务人员148名,其中127名接种过SARS-CoV-2疫苗(按样本采集日期与第2剂疫苗接种日期的时间间隔分为14~30 d组、31~60 d组、61~90 d组、91~120 d组、121~150 d组、>150 d组),21名未接种SARS-CoV-2疫苗。采用胶体金免疫层析法(LFIA)和酶联免疫吸附试验(ELISA)检测SARS-CoV-2中和抗体,采用磁微粒化学发光免疫分析法检测特异性IgM、IgG抗体,分析3种方法检测结果的一致性。结果14~30 d组ELISA中和抗体、LFIA中和抗体、特异性IgG抗体的阳性率均为100.00%,特异性IgM抗体阳性率为27.27%。随着疫苗接种时间的延长,3种方法的抗体阳性率均逐渐下降。31~120 d各组特异性IgG抗体阳性率均最高,121~150 d组和>150 d组ELISA中和抗体阳性率最高。ELISA中和抗体检测结果与LFIA的总符合率为85.14%,一致性一般(Kappa=0.698);与特异性IgM抗体的总符合率为60.14%,一致性较差(Kappa=0.144);与特异性IgG抗体的总符合率为82.43%,一致性一般(Kappa=0.649)。特异性IgG抗体与LFIA中和抗体检测结果的总符合率为83.78%,一致性一般(Kappa=0.677)。结论磁微粒化学发光免疫分析法特异性IgG抗体检测结果与LFIA、ELISA中和抗体检测结果的符合率>80%,但一致性一般,需谨慎解读特异性IgG抗体阳性结果。Objective To compare severe acute respiratory syndrome coronavirus 2(SARS-CoV-2)neutralizing antibody and specific antibody determination results,and to provide a reference for clinical interpretation of specific antibody determination results in vaccinated population.Methods Totally,148 health care personnels who were excluded from SARS-CoV-2 infection were enrolled.Among them,127 cases were inoculated with SARSCoV-2 vaccine,and they were classified into 14-30 d group,31-60 d group,61-90 d group,91-120 d group,121-150 d group and>150 d group according to the time interval between the date of sample collection and the date of the second injection of vaccine.Totally,21 cases were not inoculated with SARS-CoV-2 vaccine.Lateral flow immunoassay(LFIA)and enzyme-linked immunosorbent assay(ELISA)were used to determine SARS-CoV-2 neutralizing antibodies,and magnetic particle chemiluminescence immunoassay was used to determine SARS-Cov-2 specific IgM and IgG antibodies.The consistency of 3 methods was analyzed.Results The positive rates of ELISA neutralizing antibody,LFIA neutralizing antibody and specific IgG antibody were 100.00%,and the positive rate of specific IgM antibody was 27.27%in the 14-30 d group.With the extension of vaccination time,the positive rates of the 3 methods were decreased gradually.The positive rate of specific IgG antibody was the highest in 31-120 d groups,and the positive rate of ELISA neutralizing antibody was the highest in 121-150 d group and>150 d group.The total consistency between ELISA and LFIA for neutralizing antibody was 85.14%,and the Kappa value was 0.698.The total consistency for specific IgM antibody was 60.14%,and the Kappa value was 0.144.The total consistency for specific IgG antibody was 82.43%,and the Kappa value was 0.649.The total consistency of specific IgG antibody and LFIA neutralizing antibody was 83.78%,and the Kappa value was 0.677.Conclusions The consistency between the determination results of specific IgG antibody by magnetic particle chemiluminescence immunoassay

关 键 词：新型冠状病毒 特异性抗体 中和抗体 酶联免疫吸附试验 胶体金免疫层析法 磁微粒化学发光免疫分析法 

分 类 号：R373.1[医药卫生—病原生物学]