CLIA测丙肝抗体合并EIA测丙肝核心抗原作为丙肝感染初筛实验的探讨

The Study of Screening Test Using Anti-HCV CLIA and HCV-cAg EIA in HCV Infection

目的:比较CLIA和EIA检测抗-HCV分别合并ELISA测定总HCV-cAg对诊断HCV感染的检出率,分析CLIA抗-HCV联合EIA法HCV-cAg作为HCV感染初筛试验的重要临床意义。方法:分别用CLIA、EIA检测所有临床标本中的抗-HCV和HCV-cAg,选取抗-HCV初筛阳性样本进行HCV-RNA和ALT检测。结果:6461例样本中,EIA和CLIA检测抗-HCV阳性率分别为2.86%和3.17%,anti-HCV(+)/HCV-cAg(-)组,CLIA检出患者ALT含量与EIA检出患者无显著性差异。而HCV-RNA阳性率(98.8%)显著高于EIA检出患者(91.7%),P<0.05;anti-HCV(+)/HCV-cAg(+)组,CLIA检出患者ALT含量与EIA法检出患者无显著差异。而HCV-RNA阳性率(97.8%)显著高于EIA检出患者(86.5%),P<0.05。结论:用CLIA检测抗-HCV联合EIA法HCV-cAg进行HCV感染初筛实验,与传统EIA法抗-HCV、HCV-cAg初筛试验相比,对HCV感染患者阳性检出率更高、降低假阳性率更低、与HCV-RNA测定结果阳性符合率高,检查结果提示,可作为临床对HCV感染患者早期诊断和治疗的有效检验程序。

Objective To compare the detection rate of anti-HCV with chemiluminescence immunoassay（CLIA） and EIA,and analyze the clinical significance of anti-HCV CLIA and HCV-cAg ELISA in diagnosis of HCV infection.Methods CLIA and EIA were respectively performed to screen for anti-HCV,and HCV-cAg.Positive results of inital screening were followed up with ALT and HCVRNA.Results In 6461 patient samples,with the CLIA method 3.17% of patients and with the EIA method 2.86% had test results for anti-HCV.In anti-HCV（＋） / HCV-cAg（-） patients,no significant difference about ALT level was observed between the anti-HCV positive patients using CLIA or EIA,but significant difference about HCV-RNA was observed between the anti-HCV positive patients using CLIA（98.7%） and EIA（94.6%） individually,P 0.05.In anti-HCV（＋） / HCV-cAg（＋） patients,HCV-RNA positive rate of patients detected by CLIA（97.8%） presented significantly higher than by EIA（86.5%）,P 0.05.Conclusion Comparing with anti-HCV and HCV cAg by EIA,combining anti-HCV CLIA with HCV-cAg EIA provides higher detection rate,lower false-positive rate and good consistency with the detection results of HCV-RNA.The findings indicated,it is effective laboratory procedures for early diagnosis and treatment of hepatitis C virus infection.