血清中丙型肝炎NS3抗原ELISA检测方法的建立和初步应用

目的 评价血清中丙型肝炎病毒(HCV)游离NS3抗原的酶联免疫吸附(ELISA)检测方法的特异性和灵敏度,初步探讨该方法在临床应用中的意义.方法 对77例正常人血清标本,173例抗-HCV阳性标本和3708例抗-HCV阴性的其他类型肝炎血清标本检测HCV游离NS3抗原;对部分HCV NS3抗原阳性标本进行验证,包括HCV RNA测定、中和试验和免疫斑点试验;对11例患者的25份系列血清标本进行了HCV游离NS3抗原、HCV RNA和HCV抗体的联合检测,并结合临床资料综合分析.结果 3708例抗-HCV阴性的其他类型肝炎血清标本中有48例为HCV NS3抗原阳性,其中3030例单纯乙型肝炎和445例其他类型肝炎血清标本中分别有44例和4例为HCV NS3抗原阳性;173例HCV抗体阳性标本中有42例为HCV NS3抗原阳性;77例正常人血清标本的HCV NS3抗原检测结果均为阴性;15例HCV NS3抗原阳性标本中有9例为HCV RNA阳性;23例HCV NS3抗原阳性标本的中和率和免疫斑点试验的阳性率分别为87.0%和69.6%;25份系列血清标本的检测结果显示其HCV NS3抗原的吸光度值与时间呈负相关,并有2例HCV NS3抗原阳性标本随着血清中HCV NS3抗原的吸光度值下降,其HCV抗体转阳.结论 血清中HCV游离NS3抗原的ELISA检测方法有较好的特异性和敏感度,在发展中国家应用此方法进行HCV感染的早期诊断有一定的临床意义和推广价值.

The clinical application and analysis of hepatitis C virus NS3 antigen detection by ELISA in human serum

Objective To evaluate the specificity and sensitivity of a Hove]hepatitis C virus NS3 antigen detection immunoassay and the potential application of this assay in clinical diagnosis.Methods Samples from 77 healthy flubjects,173 anti-HCV-positive pailents and 3708 patients infected with other type of hepatitis were tested with the HCV NS3 antigen assay,some HCV NS3 antigen positive samples were validated witll HCV-RNA.neutralization and immunodot assays.Twenty.five sequential samples from 11 HCV NS3 antigen positive patients were subjected to kinetic studv.Results Forty-eight(1.3%)of 3708 antiHCV negative samples were positive for HCV NS3 antigen.Among them,44 of 3030 samples from patients only infected with HBV were HCV NS3 antigen-positive,4 of the 445 samples from patients infected with other type hepatitis were HCV NS,antigen-positive.In addition.42(24.3%)of 173 anti-HCV positive samplea were HCV NS3 antigen-positive and all 77 samples from healthy subjects were negative to HCV NS3 antigen assay.Of 15 HCV NSl antigen-positive samples,9(60%)were HCV-RNA positive.The neutralization and positive percentage of immunodot assay for 23 HCV NS3 antigen-positive sera were 87.0%(20/23)and 69.6%(16/23) respectively.Of the 25 sequential samples from 11 HCV NS3 antigen positive patients,there was a negative correlation between the A values and the duration of test.and there were correlations among their HCV NS3 antigen.HCV.RNA and anti-HCV;In addition,the anti-HCV antibodies of two sera were detected while their A values of HCV NS3 antigen decreased gradually.Conclusion The HCV NS3 antigen detection assay showed perfect specificity and higher sensitivity,it will be useful in routine laboratories test in developing countfies for earlier diagnosis of HCV infection.