新型冠状病毒康复者血浆IgM和IgG不同试剂检测结果的差异分析  

Analysis on Results of Different Reagent Kits of IgM and IgG in COVID-19 Convalescent Plasma

作　　者：陈富强[1] 朱海峰[1] 肖晨 李文超[1] 颜鑫[1] 刘虹[1] 李英莲[1] 陈剑锋[1] 贺韦东[1] 王露楠 李蓬[1] CHEN Fu-qiang;ZHU Hai-feng;XIAO Chen(Blood Center of Shandong Province,Jinan 250014)

机构地区：[1]山东省血液中心,250014 [2]国家卫生健康委临床检验中心

出　　处：《临床输血与检验》2020年第3期258-263,共6页Journal of Clinical Transfusion and Laboratory Medicine

摘　　要：目的 分析评价新型冠状病毒抗体酶联免疫吸附法(ELISA)试剂和胶体金免疫层析法(胶体金)试剂检测性能。检测新型冠状病毒感染的肺炎康复者恢复期血浆(以下简称"COVID-19 CP")IgG、IgM抗体滴度并分析亚甲蓝病毒灭活对IgG抗体滴度的影响。方法 对15例符合采集恢复期血浆要求的新冠肺炎康复者血浆标本,遵照《血站技术操作规程(2019版)》要求及经新型冠状病毒(2019-nCoV)核酸检测合格后,按照原倍、20、40、80、160、320倍稀释,采用3种IgG、2种IgM的ELISA试剂、1种胶体金试剂分别检测2019-nCoV IgG、IgM抗体。对其中7例血浆标本,比较亚甲蓝病毒灭活前、后IgG抗体滴度变化,评估病毒灭活对IgG抗体滴度的影响。结果 15例标本常规检测及2019-nCoV核酸检测均合格,但ALT偏高。2019-nCoV 3种IgG ELISA试剂检测抗体滴度、2种IgM ELISA试剂的结果差异较显著,病毒灭活前后IgG抗体滴度无明显变化。结论 国产ELISA试剂能够较好地检测出新冠病毒的IgG、IgM,但是由于试剂生产工艺、检验原理、灵敏度差异,不同试剂抗体滴度检测水平有差异。亚甲蓝/光化学法病毒灭活对2019-nCoV IgG抗体滴度无明显影响。Objective To compare ELISA and colloidal gold immunoassay reagents in IgG and IgM antibody titer detection in plasma from the COVID-19 convalescent patients (COVID-19 CP).To determine the effect of methylene blue/photochemical virus inactivation on the titer of 2019-nCoV IgG.Methods Blood samples were collected from 15 COVID-19 convalescent patients discharged from hospital in different time,and tested according to the blood station technical operation rules (2019 Edition).Novel coronavirus pneumonia (2019-nCoV) RNAs were detected by nucleic acid testing.3 IgG and 2 IgM ELISA kits,1 colloidal gold reagent were used to detect the antibody of IgM and IgG respectively,after diluted by origin,20,40,80,160 and 320 times.The titers of IgG antibody were detected in 7 plasma samples before and after the virus inactivation by methylene blue to evaluate the effect of virus inactivation on the titer of antibody.Results 15 samples of COVID-19 CP were qualified,and the 2019-nCoV nucleic acid test was negative.The ALT levels were high.There was a significant difference in the titer of IgG detected by 3 IgG and 2 IgM ELISA reagent kits from different manufacturers.Conclusion Domestic reagents can detect the IgG and IgM of 2019-nCoV,but the titer levels are different from the different reagents.It is necessary to further study the methodology and sensitivity of qualitative reagent and gradient dilution method for the detection of antibody titer.Methylene blue/photochemical virus inactivation has no significant effect on the titer of 2019-nCoV IgG.

关 键 词：酶联免疫吸附法 胶体金免疫层析法 新型冠状病毒 IGG IGM 抗体滴度 亚甲蓝 

分 类 号：R446.1[医药卫生—诊断学]