【摘要】 目的比较化学发光法(CLIA)和酶联免疫法(EIA)测抗-HCV对诊断HCV感染的检出率,分析CLIA测定抗-HCV作为HCV感染初筛试验的重要临床意义。方法分别用CLIA、EIA方法检测所有临床标本中的抗-HCV,选取抗-HCV初筛阳性样本进行HCV RNA确认试验。结果 6461例样本中,EIA和CLIA测抗-HCV阳性率分别为2.86%和3.17%;确认试验中,CLIA法抗-HCV阳性与HCV RNA的符合率为97.1%,显著高于EIA组(91.9%)。EIA法测抗-HCV,S:CO>5.0以上,与HCV RNA检测符合率可达100%;弱阳性样本,与HCV RNA符合率为69.7%;CLIA法测抗-HCV,S:CO>2.0以上,与HCV RNA检测符合率可达100%;弱阳性样本,与HCV RNA符合率为92.9%。有31例样本CLIA法抗-HCV和HCV RNA阳性,而EIA法抗-HCV阴性;有4例样本EIA法检测为阳性,而CLIA法和PCR确认试验均为阴性。结论CLIA法测抗-HCV作为HCV感染初筛实验,与传统EIA相比,特异性和阳性预测值更高,有效降低了假阳性率,有利于临床医生对HCV感染患者的早期诊断和治疗。更多还原

【Abstract】 Objective To compare the detection rate of Anti-hepatitis C virus(anti-HCV) with chemiluminescence immunoassay(CLIA) and enzyme immunoassay(EIA),and explore the clinical significance of CLIA in diagnosis of HCV infection.Methods The anti-HCV in 6461 patient samples were detected by CLIA and EIA respectively,and anti-HCV positive samples were confirmed with HCV-RNA test.Results The positive rate of anti-HCV in 6461 patient samples determined by CLIA and EIA were 3.17% and 2.86%,respectively.The positive coincidence ratio of CLIA detection confirmed by HCV RNA assay(97.1%) was obviously higher than that of EIA(91.9%).Among EIA detection samples,while S:CO value was more than 5.0,the positive coincidence ratio confirmed by HCV RNA was 100%.In weak positive samples,the positive coincidence ratio was only 69.7%.Among CLIA detection samples,while S:CO value was more than 2.0,the positive coincidence ratio confirmed by HCV RNA was 100%.In weak positive samples,the positive coincidence ratio was 92.9%.31 anti-HCV positive samples detected by CLIA were negative detected by EIA.4 anti-HCV positive samples detected by EIA were negative detected by CLIA.Conclusion CLIA provides higher specificity and positive predictive value than EIA,and reduces false-positive results.It is effective laboratory procedures for early diagnosis and treatment monitor of hepatitis C virus infection with CLIA.更多还原