两种方法检测新型冠状病毒肺炎特异性IgM抗体比较分析  

Comparison and analysis of two methods for detection of COVID-19 specific IgM antibodies

作　　者：徐云云 李宗光[1] 刘海燕[1] 胡安群[1] XU Yunyun;LI Zongguang;LIU Haiyan;HU Anqun(Department of Clinical Laboratory,Anqing City Hospital,Anqing,Anhui 246003,China)

机构地区：[1]安徽省安庆市立医院检验科,246003

出　　处：《重庆医学》2020年第17期2798-2801,共4页Chongqing medicine

基　　金：安徽省安庆市新型冠状病毒感染疫情应急科技计划项目(2020Z1004)。

摘　　要：目的对胶体金免疫层析法和荧光免疫层析法检测严重急性呼吸综合征冠状病毒2(SARS-CoV-2)进行比较,并初步探讨SARS-CoV-2特异性IgM抗体的消长情况。方法通过胶体金免疫层析和荧光免疫层析两种试剂盒对新型冠状病毒肺炎(COVID-19)患者和对照组(COVID-19流行期间经临床诊断排除COVID-19者)患者血清中SARS-CoV-2特异性IgM抗体进行检测,并对不同病程的COVID-19患者血清特异性IgM抗体检测结果进行统计分析。结果胶体金免疫层析法灵敏度(81.25%)略低于荧光免疫层析法(88.75%),两种方法的总灵敏度为91.25%;两种方法的特异度均为96.00%;两种方法均显示SARS-CoV-2特异性IgM抗体最早在感染SARS-CoV-23 d内即可产生,可持续存在1个月不消失,在病程的15~30 d内阳性率最高;荧光免疫层析法中,早期组与治疗后期组、治愈随访组比较,血清SARS-CoV-2特异性IgM抗体水平差异均有统计学意义(P<0.05),早期组与治疗初期组比较,差异无统计学意义(P>0.05)。治疗初期组、治疗后期组与治愈随访组间两两比较,差异均无统计学意义(P>0.05)。结论荧光免疫层析法检测SARS-CoV-2特异性IgM抗体的灵敏度高于胶体金免疫层析法,特异度无差别,且在感染15~30 d内达高峰。血清SARS-CoV-2特异性IgM抗体检测可应用于SARS-CoV-2感染的筛查并与核酸检测结果互为补充。Objective The colloidal gold immunochromatographic method and fluorescent immunochromatographic method for the detection of severe acute respiratory syndrome coronavirus 2(SARS-CoV-2)were compared,and the growth and decline of SARS-CoV-2-specific IgM antibodies were initially discussed.Methods Colloidal gold immunochromatography and fluorescence immunochromatography kits were used to detect SARS-CoV-2-specific IgM antibodies in serum of patients with corona virus disease 2019(COVID-19)and patients in the control group(non COVID-19 diagnosed during the opidemic period),and the serum specific IgM antibodies of COVID-19 patients in different courses were analyzed statistically.Results The sensitivity of colloidal gold immunochromatography(81.25%)was slightly lower than that of fluorescent immunochromatography(88.75%).The total positive rate of both methods was 91.25%;the specificity of both methods is 96.00%.Both methods showed SARS-CoV-2-specific IgM antibodies could be produced as early as 3 days after infection with SARS-CoV-2,it persisted for 1 month and didn′t disappear,and reached a peak within 15-30 days.In the fluorescence immunochromatography,the serum SARS-CoV-2-specific IgM antibody levels in the early group were significantly different from those in the late treatment group and the cured follow-up group(P<0.05).There was no significant difference between the early group and the early treatment group(P>0.05).There was no significant difference between the early treatment group,the late treatment group and the cured follow-up group(P>0.05).Conclusion The sensitivity of fluorescence immunochromatography for detecting SARS-CoV-2-specific IgM antibodies is higher than that of colloidal gold immu-nochromatography,and there is no significant difference in specificity;the serum SARS-CoV-2 specific IgM antibody detection can be applied to the screening of SARS-CoV-2 infection,which can become supplement of nucleic acid test results.

关 键 词：冠状病毒感染 肺炎 新型冠状病毒 新型冠状病毒肺炎 特异性IGM抗体 胶体金免疫层析法 荧光免疫层析法 

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