两种新型冠状病毒抗体检测试剂的临床应用评价

Clinical application evaluation of two SARS-CoV-2 antibody detection reagents

目的探讨两种新型冠状病毒(SARS-CoV-2)抗体检测试剂的临床应用价值。方法选取2020年1月16日至3月1日在广西壮族自治区人民医院邕武院区经核酸检测阳性的新型冠状病毒肺炎(COVID-19)确诊患者69例(确诊病例组)和同期在该院排除SARS-CoV-2感染的38例体检人员(阴性对照组)作为研究对象,两组采用两种胶体金免疫层析技术(GICA)试剂检测血清SARS-CoV-2总抗体、IgM、IgG,采用实时荧光定量聚合酶链反应法检测SARS-CoV-2核酸。结果万孚总抗体和英诺特IgG联合IgM(IgG或IgM任一阳性确定为阳性)诊断COVID-19的灵敏度、特异度、阳性预测值、阴性预测值和约登指数分别为98.55%和97.10%、100.00%和92.11%、100.00%和95.71%、97.44%和94.59%、0.986和0.892。两种试剂检测结果的一致性检验kappa值为0.918(P<0.05),两种试剂的一致性好。结论该研究中的两种抗体检测试剂可以作为核酸检测的重要补充。

Objective To explore the clinical application of Severe Acute Respiratory Syndrome Coronavirus 2(SARS-CoV-2)antibody detection reagents.Methods From January 16 to March 1,2020,69 confirmed COVID-19 patients with positive nucleic acid test(confirmed case group)and 38 physical examiners excluded from SARS-CoV-2 infection(negative control group)in Yongwu Branch of the People's Hospital of Guangxi Zhuang Autonomous Region in the same period were taken as research objects.Total antibody,IgM and IgG of serum SARS-CoV-2 were detected by colloidal gold immunochromatography assay(GICA).The real-time fluorescence quantitative polymerase chain reaction was used to detect SARS-CoV-2 nucleic acid.Results The sensitivity,specificity,positive predictive value,negative predictive value,and Youden index of Wondfo total antibody and Innovita IgG combined with IgM(note:IgG or IgM was determined to be positive)in the diagnosis of COVID-19 were 98.55%and 97.10%,100.00%and 92.11%,100.00%and 95.71%,97.44%and 94.59%,0.986 and 0.892.The consistency check kappa value of the two reagents was 0.918(P<0.05),indicating that the consistency of the two reagents was good.Conclusion The two antibody detection reagents in this study can be used as an important supplement to nucleic acid detection.