HCV 核心抗原测定用于丙型肝炎早期诊断.doc

PAGE PAGE 1 HCV核心抗原测定用于丙型肝炎早期诊断 摘要目的:评估HCV核心抗原ELISA测定法用于HCV早期诊断的临床价值。方法:采用HCV抗体、HCcAg测定法及荧光定量PCR对1948份未感染HCV阴性血样(1500份供血者的血样、400份体检的血样及48份非HCV患者血样)进行了HCV血清学及分子生物学检测。结果:对非HCV感染标本测定结果表明,1500份血库标本中有8份在初次HCV核心抗原测定时出现阳性(0.53%)400份体检血样HCV核心抗原测定结果全阴;48例住院非HCV患者HCV核心抗原检测结果只有1例阳性(2.08%),上述抗原阳性血样的HCVPCR均为阴性,特异性为99.94%;我们96份HCV感染的血样(55例来自我院传染科HCV患者病人;41份来自9套HCV血清panel)进行了HCV核心抗原测定及HCVRNA测定,结果表明有91份HCV核心抗原测定阳性,敏感性为94.79%;对9套HCV血清panel测定结果表明,与Anti-HCV方法相比,HCV抗原测定及HCV荧光定量PCR都能显著地将HCV窗口期平均缩短至36天;方法内及方间精密度的CV值均小于10%;结论:HCV核心抗原ELISA测定法具有与传统HCV-RT-PCR相比的高度敏感性及特异性,可以明显的缩HCV早期感染窗口期;它应用将会显著地降低HCV感染。 关键词肝炎病毒,丙型;核心抗原;聚合酶链反应 中图分类号R987.7文献标识码A文章编号1671-8852(2005)01-0000-00 ClinicalValueofHCVCoreAntigenEnzymeImmunoassayinEarlyDiagnosis HongJun,RaoYongcai,LiYan,etal DepartmentofClinicalLab,RenminHospital,WuhanUniversity,Wuhan430060,China Abstract Objective:ToassesstheperformanceofanewlydevelopedELISAforthedetectionofHCVcoreantigenanditssuitabilityforuseinthescreeningofbloodunitsinordertoidentifyinfectingsamplesthatdonotcontainspecificantibodies.Methods:1500serafromblooddonors,400generalpopulationsamples,48patientsamples(withoutHCVinfection),55HCVpatientsamples(HCVRNA-positive,andanti-HCV-negative),3naturalseroconversionpanels,and6commercialseroconversionpanelsweretestedwithHCVIgGanti-bodytest,coreantigentestandRNAPCRtestC.Results:Eight(0.53%)blooddonorsamples,0(0%)generalpopulationsamples,and1(2.08%)patientsamples(withoutHCVinfection)wereinitiallyreactive;1serasampleswaspositiveonrepetition.These9samplestestedbyreversetranscription-PCRwerenegative.ThespecificityandsensitivityofHCVcoreantigentestwere99.94%and94.79%.ThereductionindiagnosticwindowperiodresultingfromuseofHCVCoreantigentestandRNAPCRinthe9panelswasequalonaverageto36days.Theintra-andinter-assayprecisionofHCVcoreantigenassaywaslessthan10%.Conclusion:TheHCVcoreantigenassayshowedhighsensitivityandspecificityandcouldobviouslyreducethewindowsperiodofHCV. KeyWordshepatitisCvirus;coreantigen;polymerasechainreaction 临床上诊断HCV感染主要依赖HCV抗