不同方法筛查血液透析人群中丙型肝炎病毒感染结果的比较分析

Comparing Three Screening Methods of HCV Infection in Hemodialysis Patients

目的:探讨在血液透析(HD)人群中采用不同方法对丙肝抗体(抗-HCV)检测的灵敏度和特异性。方法:使用电化学发光法(ECLIA)和酶联免疫吸附试验(ELISA)筛查HD、非HD人群中丙型肝炎病毒(HCV)感染情况,用重组免疫印迹法(RIBA)对HCV感染进行确证试验,评估上述方法的敏感性及特异性。并对82例选择组(非HD患者,ECLIA检测抗-HCV结果数值为30以下)进行相关检测。结果:RIBA确认HD组、非HD组阳性例数分别为23、46例。ECLIA检测结果 HD组为26例阳性、427例阴性,敏感性100%,特异性99.3%;非HD组53例阳性、3 320例阴性,敏感性100%,特异性99.8%;选择组ECLIA检测抗-HCV阳性82例,RIBA确认结果 63例阳性,19例阴性(假阳性),假阳性占总数的23.2%,无假阴性。ELISA方法检测结果HD组为22例阳性、431例阴性,敏感性95.7%,特异性100%;非HD组为43例阳性、3 330例阴性,敏感性93.5%,特异性100%;选择组ELISA法检测抗-HCV阳性57例,阴性25例,RIBA确认假阴性6例,假阳性1例,假阴性占总数的7.3%,假阳性占总数的1.2%。结论:在HD人群中进行HCV感染的筛查,ECLIA敏感性优于ELISA,ECLIA用于透析患者抗-HCV初筛,可减少甚至杜绝交叉感染的机会。ELISA特异性优于ECLIA,为提高HD人群HCV感染的诊断准确性,特别是对于检测结果在灰区范围的患者,多种方法联合检测非常必要。

Objective:To investigate the sensitivity and specificity of different methods for detection of hepatitis C antibody(anti-HCV)in hemodialysis(HD)patients. Methods:Using ECLIA,ELISA to screen hepatitis C virus in dialysis patients(n=453)and non-dialysis patients(n=3 373),then the positive samples by recombinant immunoblot assay(RIBA)were confirmed to evaluatethe sensitivity and specificity of the three examinations.The samples in select group(82 non-dialysis patients whose anti-HCV werepositive but lower than 30)were also detected. Results:There were 23,46 cases of positive samples in dialysis group and non-dialysisgroup confirmed with RIBA.By ECLIA,26 in dialysis group were positive,427 were negative,the sensitivity was 100% and thespecificity was 99.3%,and 53 in non-dialysis group were positive, 3 320 were negative,the sensitivity was 100% and thespecificity was 99.8%. And 63 were positive confirmed by RIBA in select group,19 were negative,false positive rate was 23.2%,false negative rate was 0%. By ELISA,22 in dialysis group were positive,431 were negative,the sensitivity was 95.7% and thespecificity was 100%,and 43 in non-dialysis group were positive,3 330 were negative,the sensitivity was 93.5% and the specificitywas 100%. And 57 were positive by ELISA in select group,25 were negative as well,6 were false negative by RIBA,1 was falsepositive,false negative rate was 7.3%,false positive rate was 1.2%. Conclusions:ECLIA is more sensitive and specific than ELISAin screening HCV infection in hemodialysis patients,as a preliminary screening test,ELISA can reduce or eradicate HCV crossinfection. To increase the diagnostic accuracy,especially to patients whose results are in grey area,combined detection of severalmethods is very necessary.