新型冠状病毒血清特异性抗体不同检测方法的临床应用评价

Clinical evaluation of different methodsforthe detection of 2019-nCoV antibodies in serum

目的探讨胶体金免疫层析法(GICA)、酶联免疫吸附法(ELISA)及化学发光法(CLIA)检测新型冠状病毒(2019-nCoV)血清特异性抗体在新型冠状病毒肺炎(COVID-19)诊断中的临床应用价值。方法对21例核酸检测阳性的COVID-19确诊病例的26份血清标本,以及排除2019-nCoV感染的30份血清作为阴性对照,采用不同方法学的检测试剂盒进行新型冠状病毒血清学特异性抗体检测。结果四种GICA法检测试剂敏感性为69.2%~80.7%;特异性为96.7%~100.0%;阳性预测值95.2%~100.0%,阴性预测值为78.9%~85.7%;漏诊率和误诊率分别为19.2%~30.8%和0.0%~3.3%,约登指数为0.69~0.81。ELISA及CLIA检测试剂敏感性分别为92.3%和96.2%,特异性及阳性预测值可达到100.0%,阴性预测值分别是93.8%和96.8%,漏诊率分别为7.7%和3.9%,误诊率为0.0%,约登指数分别为0.92和0.96。CLIA检测2019-nCoV总抗体灵敏度高于其他两种方法。结论三种方法学抗体检测试剂盒均具有较好的敏感性和特异性,可用于COVID-19的辅助诊断,本研究初步获得的特异性抗体动态变化特征可为COVID-19血清流行病学调查研究提供重要的基础依据。

Objective To explore the clinical value of colloidal gold immunochromatography(GICA),enzyme linked immunosorbent assay(ELISA)and chemiluminescence(CLIA)in detection of SARS-CoV-2.Methods The GICA,ELISA and CLIAwere used to detect the serum sample,which was come from patients with SARS-CoV-2 infection(26 serum samples)and without SARS-CoV-2 infection(30 serum samples).Results The sensitivity,specificity,positive predictive value and negative predictive value of the four GICA reagents were 69.2%~80.7%,96.7%~100%,95.2%~100.0%and 79.9%~85.7%,respectively;the rates of missed diagnosis and misdiagnosis were 19.2%~30.8%and 0.0%~3.3%,respectively;the Youden index was 0.69~0.81;the sensitivity of the ELISA and CLIA detection reagents were 92.3%and 96.2%;the specificity,positive predictive value of the ELISA and CLIA detection reagents were 100.0%,the negative predictive value,the rates of missed diagnosis and misdiagnosis were 93.8%and 96.8%,7.7%and 3.9%,0.0%,respectively;the Youden index were 0.92 and 0.96.Chemiluminescent immunoassay had higher sensitivity than that in GICA and ELISA.Conclusion The three types of SARS-CoV-2 antibody-detection kits have good sensitivity and specificity for detection of antibodies against SARS-CoV-2,and it could aid the clinical diagnosis of COVID-19.The dynamic characteristics of production of SARS-CoV-2-specific antibodies could provide important scientific bases for epidemiologic investigations.