CLIA检测新型冠状病毒(SARS-CoV-2)的IgM和IgG抗体在新型冠状病毒肺炎(COVID-19)辅助诊断中的应用价值

The value of CLIA to detect the IgM and IgG antibodies of the new coronavirus(SARS⁃CoV⁃2)in the auxiliary diagnosis of the new coronavirus pneumonia(COVID⁃19)

目的在COVID-19(新型冠状病毒肺炎)辅助诊断中对SARS-CoV-2(新型冠状病毒)的IgG与IgM抗体予以CLIA(化学发光免疫分析技术)检测的应用效果。方法把2019年1月至2020年12月时段我院接收的COVID-19(阳性)患者58例作为观察组,同期另选取依照SARS-CoV-2核酸检测与临床诊断排除的COVID-19发热(阴性)患者41例作为对照组。对研究所选对象的164份血清行CLIA检测SARS-CoV-2的IgG与IgM抗体,分析诊断效果。结果SARS-CoV-2 IgG检测特异度、灵敏度分别是95.12%、87.80%,阴性预测值、阳性预测值分别是72.22%、98.18%,检测符合率是89.63%。SARS-CoV-2 IgM抗体检测特异度、灵敏度分别是68.29%、57.72%,阴性预测值、阳性预测值分别是35.00%、95.55%,检测符合率是60.37%。SARS-CoV-2IgM联合IgG抗体检测特异度、灵敏度分别是97.56%(40/41),灵敏度是98.37%(121/123),阳性预测值是99.18%(121/122),阴性预测值是95.24%(40/42),符合率是98.17%(161/164)。经比较发现,联合检测结果明显高于单一检测结果,数据结果相比差异有统计学意义(P<0.05)。从发病<21天开始对IgM抗体检出,伴随病情延展阳性率呈现递增趋势,当22~42天时达到峰值,随后阳性率呈现递减趋势,>42天后阳性率所占比为40.00%。用相同方法,从发病<21天开始对IgG抗体检出,伴随病情延展阳性率呈现递增趋势,当22~42天时达到峰值。与IgM抗体不同,在22~42天、>42天时段IgG抗体阳性率的水平都相对较高。结论目前临床对于SARS-CoV-2抗体的诊断主要包括CLIA检测、SARS-CoV-2核酸检测,相比二者单一检测,开展CLIA检测联合SARS-CoV-2核酸检测,其诊断效果更好,在辅助诊断COVID-19中能起到重要作用。

Objective The application effect of CLIA(chemiluminescence immunoassay technology)detection on SARS⁃CoV⁃2(new coronavirus)IgG and IgM antibodies in the auxiliary diagnosis of COVID⁃19(new coronavirus pneumoni⁃a).Methods 58 COVID⁃19(positive)patients received in our hospital from January 2019 to December 2020 were taken as the observation group;the control group selected during the same period were excluded based on clinical diagnosis and SARS⁃CoV⁃2 nucleic acid test And the results showed negative COVID⁃19 fever,a total of 41 cases were selected.CLIA was performed on 164 sera of selected subjects to detect SARS⁃CoV⁃2 IgG and IgM antibodies to analyze the diagnostic effect.Results The specificity and sensitivity of SARS⁃CoV⁃2 IgG detection were 95.12%and 87.80%,the negative predictive value and positive predictive value were 72.22%and 98.18%,respectively,and the detection coincidence rate was 89.63%.The specificity and sensitivity of SARS⁃CoV⁃2 IgM antibody detection are 68.29%and 57.72%,respectively,the negative predictive value and positive predictive value are 35.00%and 95.55%,respectively,and the detection coinci⁃dence rate is 60.37%.The specificity and sensitivity of SARS⁃CoV⁃2IgM combined with IgG antibody detection are 97.56%(40/41),the sensitivity is 98.37%(121/123),the positive predictive value is 99.18%(121/122),and the nega⁃tive predictive value is 95.24%(40/42),the coincidence rate is 98.17%(161/164).After comparison,it was found that the combined test result was significantly higher than the single test result,and the difference between the data results was statistically significant(P<0.05).IgM antibodies were detected from the onset of<21 days,and the positive rate of disease extension showed an increasing trend.It reached a peak at 22 to 42 days,and then the positive rate showed a decreasing trend.After 42 days,the positive rate accounted for 40.00%.Using the same method,the IgG antibody was detected from the onset of<21 days,and the positive rate of the disease showed an increasing trend with the extension of the disease,reac⁃hing a peak at 22 to 42 days.Unlike IgM antibodies,the positive rate of IgG antibodies is relatively high in the 22~42 days and>42 days.Conclusion The current clinical diagnosis of SARS⁃CoV⁃2 antibodies mainly includes CLIA detection and SARS⁃CoV⁃2 nucleic acid detection.Compared with the single detection of the two,the combination of CLIA detection and SARS⁃CoV⁃2 nucleic acid detection has better diagnostic effects.It can play an important role in assisting the diagnosis of COVID⁃19.