不同ELISA试剂与1种假病毒中和试验检测COVID-19康复者恢复期血浆抗体结果分析  

Assessment of 3 enzyme linked immunosorbent assays and 1 pseudotype lentivirus-based neutralization test in detecting serum antibody in convalescent plasma from COVID-19

作　　者：王立林[1] 邬旭群[1] 邬林枫[1] 宁理 卢亮[1] 刘晋洪 李然 李彤[1] 陈利民[2] 徐敏[2] 曾劲峰[1] WANG Lilin;WU Xuqun;WU Linfeng;NING Li;LU Liang;LIU Jinhong;LI Ran;LI Tong;CHEN Limin;XU Min;ZENG Jinfeng(Shenzhen Blood Center,Shenzhen 518035,China.1.ShenzhenBlood Center,Shenzhen 518035,China;Institute of Blood Transfusion,Chinese Academy of Medical Sciences&Peking Union Medical College,Provincial key Laboratory for Transfusion Transmitted Diseases of Sichuan Province,Chengdu 610052,China)

机构地区：[1]深圳市血液中心,广东深圳518035 [2]中国医学科学院北京协和医学院输血研究所四川省输血传播疾病医学重点实验室

出　　处：《中国输血杂志》2022年第1期5-9,共5页Chinese Journal of Blood Transfusion

基　　金：2020年度广东省医学基金项目(A2020259);深圳市医学重点学科建设经费(SZXK070);深圳市医疗卫生三名工程项目(SZSM201811092)。

摘　　要：目的了解不同的严重急性呼吸系统综合征冠状病毒2(SARS-CoV-2)ELISA抗体试剂应用于核酸检测确诊新型冠状病毒肺炎(COVID-19)康复者恢复期血浆抗体检测的结果差异性。方法应用3种SARS-CoV-2 ELISA抗体试剂(代以ELISA试剂1、2、3)和1种假病毒中和试验(ppNAT),于2020年9月检测深圳地区30(人)份COVID-19康复者恢复期血浆,同时取32(人)份2019年2月冻存的健康献血者血浆作为实验对照组。以实时荧光RT-PCR检测新型冠状病毒核酸检测为参考标准,分析3种ELISA试剂对COVID-19康复者恢复期血浆病毒抗体的检出效能及不同免疫学试剂检测结果与康复者年龄、性别、住院时间、病情严重程度相关性。结果ppNAT和3种ELISA的IgG试剂在恢复期献浆者中检出率整体高于IgM试剂,ELISA(试剂)1、2、3和ppNAT的SARS-CoV-2 IgG抗体阳性检出率分别为100%(30/30)、93.33%(28/30)、96.67%(29/30),阴性对照组检出率均为0;SARS-CoV-2 IgM抗体阳性检出率分别为93.33%(28/30)、70%(21/30)、46.67%(14/30);阴性对照组中,IgM、IgG抗体检出率0。Pearson相关性分析:ELISA2 IgG抗体检测结果与ELISA3 IgG抗体检测结果相关系数(r)0.765(P<0.01),ppNAT检测结果、ELISA3 IgG抗体检测结果与康复者年龄的r值分别为0.422,0.385(P<0.05);住院时间、病情严重程度、性别与3种ELISA试剂SARS-CoV-2抗体检测值与Cut off比值(S/CO)无明显相关性(P>0.05)。结论不同ELISA试剂检测COVID-19康复者恢复期血浆,SARS-CoV-2 IgM抗体检出率差异较大;年龄一定程度影响抗体生成。Objective To assess three severe acute respiratorysyndrome coronavirus 2(SARS-CoV-2)enzyme linked immunosorbent assays(ELISA)and one pseudotype lentivirus-based neutralization test(ppNAT)in detecting the convalescent plasma antibody levles from COVID-19.Methods 30 COVID-19 convalescent plasma samples were screened for antibodies against SARS-CoV-2 using three kinds of SARS-CoV-2 ELISA reagents and one ppNAT test in Shenzhen.The controls consisted of plasma samples from 32 healthy blood donors in February 2019.The diagnostic efficacy analysis of various SARS-CoV-2 ELISA reagents was performed using real-time fluorescent Polymerase Chain Reaction(RT-PCR).We also analyzed correlation between different immunological reagents and the age,gender,hospitalization,and severity of illness.Results The positive yielding rate of ppNAT and three kinds of IgG ELISA was higher than that of IgM ELISA.The positive yielding rates of three kinds of IgG ELISA were 100%(30/30),93.33%(28/30),and 96.67%(29/30)respectively,while the yielding rates in control group were all 0.The positive yielding rate of three IgM ELISAs were 93.33%(28/30),70%(21/30)and 46.67%(14/30).All the cases from negative control group were negative for IgG and IgM.Pearson correlation coefficient was calculated;there was a strong correlation between ELISA reagent 2 IgG and ELISA reagent 3 IgG(r=0.765,P<0.01).The correlation between ppNAT,ELISA reagent 3 IgG and the age of recovered patients was 0.422 and 0.385,respectively(P<0.05),while no significant correlation was found between the duration of hospitalization,severity of illness,gender and antibody signal/cutoff(S/CO)(P>0.05).Conclusion In the convalescent plasma with nucleic acid confirmed covid-19,the yielding rates of different IgM antibodies varied greatly.Antibody levels were influenced by age to some extent.

关 键 词：SARS-CoV-2抗体 康复者 血浆 ELISA试剂 假病毒中和试验 IgG抗体检出率 IgM抗体检出率 

分 类 号：R446.6[医药卫生—诊断学] R563.1[医药卫生—临床医学]