ELISA检测抗-HCV灰区、弱反应标本与FQ-PCR检测结果对比分析

A Compararison of ELISA with FQ-PCR for Detection of Anti-HCV Antibodies in the Samples Near Critical Value

目的探讨丙型肝炎病毒抗体(抗-HCV)酶联免疫吸附试验(ELISA)检测呈灰区、弱阳性样本采用荧光定量PCR(FQ-PCR)的复检情况。方法选取2012年4月~2016年3月于本院手术和输血治疗的1 348例患者为研究对象,根据ELISA法抗-HCV检测结果将患者标本分为:A组:阴性(S/CO<0.3)240例;B组:灰区(0.7≤S/CO<1)902例;C组:弱反应性(1≤S/CO<3.8)206例,所有研究对象均采用FQ-PCR复检,比较两种方法检测结果。结果 B组灰区和C组弱反应性标本中,FQ-PCR复检分别有41例(4.54%)和172例(83.49%)HCVRNA浓度>1 000 IU/ml;ELISA检测抗-HCV双试剂灰区HCVRNAFQ-PCR阳性率高于单试剂灰区,差异有统计学意义(P<0.05);ELISA检测抗-HCV双试剂弱反应性HCVRNA FQ-PCR阳性率与单试剂弱反应性比较,差异无统计学意义(P>0.05)。结论 ELISA法检测抗-HCV为灰区、弱反应性标本存在一定的HCV RNA阳性标本漏检和误诊,采用FQ-PCR检测对于HCV感染早期诊断和治疗尤为重要。

Objective To Use the fluorescence quantitative PCR(FQ-PCR)for confirming antibodies against hepatitis C surface antigen(anti-HCV)that had been tested by enzyme linked immunoassay(ELISA).Methods1348patients who had experienced blood transfusion and operation were collected from April2012to March2016.The patients were divided into three groups,group A included240samples with negative anti-HCV detected by ELISA(S/CO<0.3);group B covered902samples with anti-HCV on cutoff value(0.7≤S/CO<1);and group C included206samples with weak reaction of anti-HCV detected by ELISA.Results Among groups B and C,41(4.54%)and172(83.49%)samples were found to have HCV RNA level>1000IU/ml rechecked by FQ-PCR.FQ-PCR demonstrated a high positive rate in the samples on the cutoff value tested by ELISA double reagents(P<0.05);while no difference was noted between the samples with weak reaction of HCV RNA when tested with ELISA and FQ-PCR(P>0.05).Conclusion The false negative and misdiagnosis rate of ELISA is high in the samples near HCV cutoff value and in weak reaction,suggesting that FQ-PCR is useful for early diagnose of HCV patients.