新型冠状病毒血清特异性抗体不同方法学检测分析

Analysis of detection of novel coronavirus-specific antibodies by different methods

目的:比较不同血清学检测方法检测新型冠状病毒特异性抗体的阳性率,比较其在新型冠状病毒肺炎(新冠肺炎)患者和无症状感染者中的差异。方法:使用5种胶体金免疫层析法检测试剂A、B、C、D、E和一种磁微粒化学发光检测试剂F对入院的10例确诊患者和11例无症状感染者血清标本进行检测,其中A试剂检测总抗体,B、C、D、E、F试剂检测抗体IgM,C、D、E、F试剂检测抗体IgG。依据《新型冠状病毒肺炎诊疗方案(试行第九版)》中相关规定以20例已排除新冠病毒感染者为空白对照,计算不同试剂检测抗体IgM和IgG分别在新冠肺炎患者和无症状感染者中的阳性率,通过统计学分析进行比较,实验中所选研究对象均未接种新型冠状病毒肺炎疫苗。结果:总抗体:A试剂阳性检出率为100%,其测定总抗体,不区分抗体IgM和IgG。抗体IgM:10例新冠肺炎患者和11例无症状感染者分别使用B、C、D、E、F方法检测IgM抗体,不同方法学的阳性检出率差异均存在统计学意义(P<0.05),在新冠肺炎组和无症状感染者组中,胶体金免疫层析法C、D、E检测抗体IgM的阳性检出率均显著低于磁微粒化学发光法F。抗体IgG:新冠肺炎组使用C、D、E、F方法检测IgG抗体的阳性检出率差异不存在统计学意义(P>0.05),无症状感染组使用C、D、E、F检测IgG抗体的阳性检出率差异存在统计学意义(P<0.05),胶体金免疫层析法D、E检测抗体IgG的阳性检出率在无症状感染组中低于化学发光法F。结论:磁微粒化学发光法相较于胶体金免疫层析法检测新冠肺炎患者抗体IgM以及无症状感染者抗体IgM和IgG具有更高的阳性检出率,更有利于区分既往感染和当前感染,但其对检测条件有较高要求,检测时间相对较长;胶体金免疫层析法检测速度快,灵敏度相对磁微粒化学发光法较低。

Objective:To compare the positive rates of different serological testing methods for the detection of new coronavirus-specific antibodies,and compare the differences between patients with new coronary pneumonia and those with asymptomatic infection.Methods:Five colloidal gold immunochromatographic detection reagents A,B,C,D,E and a magnetic particle chemiluminescence detection reagent F were used to test the serum samples of 10 confirmed patients and 11 asymptomatic infections in the hospital.Among them,A reagent was used to detect total antibody,B,C,D,E,F reagents were used to detect antibody IgM,C,D,E,F reagents were used to detect antibody IgG.According to the relevant provisions of the"New Coronary Pneumonia Diagnosis and Treatment Plan(Trial Seventh Edition)",20 cases of patients who have been excluded from new coronavirus infection were used as blank controls,and the positive rate of antibodies IgM and IgG was detected by different reagents in patients with new coronary pneumonia and asymptomatic infections were calculated and compared through statistical analysis.None of the subjects in the study had received the COVID-19 vaccine.Results:Total antibody:the positive detection rate of reagent A was 100%,which measured total antibody without distinguish between antibody IgM and IgG.Antibody IgM:10 patients with new coronary pneumonia and 11 patient with asymptomatic infection used methods B,C,D,E,and F to detect the positive rates of IgM antibodies,and the positive detection rate of different methods were statistically significant(P<0.05).In the new coronary pneumonia group and the asymptomatic infection group,the positive rate of the antibody IgM detected by the colloidal gold immunochromatographic method C,D,E was significantly lower than that of the magnetic particle chemiluminescence method F.Antibody IgG:the new coronary pneumonia group used methods C,D,E,and F to detect the positive rate of IgG antibodies,and the difference was not statistically significant(P>0.05),and the asymptomatic infection group used C,D,E,and F to detect IgG antibodies positive rate,the difference was statistically significant(P<0.05).Colloidal gold immunochromatographic methods D and E showed a lower positive test for antibody IgG than chemiluminescence method F in the asymptomatic infection group.Conclusion:Compared with the colloidal gold immunochromatographic method,the magnetic particle chemiluminescence method has a higher positive detection rate for detecting antibodies IgM in patients with new coronary pneumonia and antibodies IgM and IgG in asymptomatic infections.It is more helpful to distinguish past infection from current infection.However,it has higher requirements on detection conditions,and the detection time is relatively long.Colloidal gold immunochromatography has a fast detection speed,but its sensitivity is lower than that of magnetic particle chemiluminescence method.