ROC曲线对ECLIA法预测HCV感染的最佳S/CO值的确定和分析  

Determination and analysis of optimal S/CO value of ECLIA for predicting HCV infection by ROC curve

作　　者：杨泽 黎明新[1] YANG Ze;LI Mingxin(Department of Clinical Laboratory,Affiliated Central Hospital of Shenyang Medical College,Shenyang,Liaoning 110000,China)

机构地区：[1]沈阳医学院附属中心医院检验科,辽宁沈阳110000

出　　处：《检验医学与临床》2020年第9期1166-1168,1172,共4页Laboratory Medicine and Clinic

基　　金：国家大学生科研基金项目(20160827)。

摘　　要：目的应用受试者工作特征(ROC)曲线分析丙型肝炎病毒(HCV)抗体阳性预测值≥95%的最佳S/CO值,以此临界值来限制临床上需要进行确证试验的患者数量。方法收集2017年2月至2018年6月该院门诊和住院患者经过电化学发光免疫分析(ECLIA)法初筛检测有反应性标本(S/CO≥1)167份,阴性标本(S/CO<1)10份,并进行HCV RNA和重组免疫印迹试验(RIBA)的补充确证试验,得到临床上可信的真阳性及假阳性标本,经ROC曲线分析得出结果。结果将初筛结果为1≤S/CO<10的54份标本进行双重确证试验后得到阳性标本17份(34.0%),阴性标本33份(占66.0%),不确定的4份标本(定期随访)。当S/CO≥10,经HCV RNA及RIBA双重确证后得到的结果均为阳性。经ROC曲线分析,得到曲线下面积(AUC)为0.971,此时的最佳诊断临界值为8.83。结论若ECLIA法检测结果显示"1≤S/CO<8.83",应提示为"有反应性标本",并注以阳性预测值≤95%,建议1个月后复查或进一步确证检测。Objective The receiver operating characteristic(ROC)curve was used to calculate the optimal S/CO value of the positive predictive value of hepatitis C antibody ≥95%,and the critical value was used to limit the number of patients clinically required for confirmatory testing.Methods From February 2017 to June2018,167 reactive specimens(S/CO≥1)and 10 non-reactive specimens(S/CO<1)were collected from outpatients and inpatients in the Affiliated Central Hospital of Shenyang Medical College through the initial screening of electrochemiluminescence immunoassay(ECLIA),and supplemental confirmation tests of HCV RNA and RIBA were performed to obtain clinically credible true positive and false positive patients,which were analyzed by ROC curve.Results A total of 54 specimens with 1≤S/CO<10,17 patients(34.0%)who were positive after double confirmation,33 patients(66.0%)were negative,and 4 patients were indeterminate(regular follow-up).When the samples with S/CO≥10,the specimens were double confirmed by HCV RNA and RIBA,the results were all positive.According to the statistical analysis of the ROC curve,the area under the ROC curve(AUC)was0.971,and the optimal diagnostic threshold was 8.83.Conclusion The "1≤S/CO<8.83" sample should be indicated "reactive specimen",and the positive predictive value is≤95%,it is recommended to review or further confirm the test one month later.

关 键 词：丙型肝炎病毒抗体 电化学发光免疫分析法 重组免疫印迹试验 假阳性 

分 类 号：R446.61[医药卫生—诊断学]