丙型肝炎病毒E1抗体检测及临床应用

Detection of antibody against hepatitis C virus first envelope (HCV-E1) protein and its clinical application

目的 研究丙型肝炎患者血清中HCVE1抗体 ,确定HCVE1抗原在抗体检测中的应用价值。方法 应用酶联免疫吸附测定 (ELISA)方法检测 80份卫生部第 3代HCV血清参比品 ,82 1例职业献血员血清和 72 0例临床肝炎患者血清中E1抗体。结果 用E1抗原单包板检查 80份卫生部血清参比品的阳性符合率为 70 %、阴性符合率为 10 0 % ;从 82 1例职业献血员血清样品中检出E1抗体阳性率为1 9% ;从 72 0例临床肝炎患者血清中检出E1抗体阳性率为 6 8%。大部分E1抗体阳性血清 ,同时也能和HCV的Core、NS 3抗原及NS 5A抗原呈阳性反应 ,但有个别血清只对E1抗原呈阳性反应。用市购HCV抗体ELISA检测试剂盒检测为阴性的 2 18例肝炎科门诊患者、813例献血员和 84 8例一般人群血清 ,用E1抗原单包板复检 ,检出的阴性率分别为 1 4 %、1 1%和 0 9%。在 3例患者血清学转变的追踪研究中 ,HCVE1抗体都同现最早。结论 用E1工程蛋白检测E1抗体具有较高的灵敏度和特异性。E1抗体在HCV感染患者中普遍存在而且早出现 ,在临床诊断上是有意义的。

Objective To study the antibody against hepatitis C virus first envelope (HCV E1) protein in the sera from patients with HCV and to evaluate the application of HCV E1 antigen in detection of HCV antibody.Methods Purified E1 engineering protein was used as antigen to develop an ELISA for detecting E1 antibody in 80 national reference sera,821 blood donors' sera and l20 sera from clinical patients with hepatitis.Results Anti HCV E1 was positive in 70% (28/40) and negative in 100% (40/40) of 80 national reference sera, and 1.9%(16/821) was positive in blood of the sera donors' and 68%(492/720) positive in sera of patients with hepatitis.Most anti HCV E1 positive sera were positive for core,NS 3 and NS 5A,but only a few sera were positive for E1 antigen.Of the sera from 218 clinical patients,813 blood donors and 848 normal people that were anti HCV negative tested by commercial anti HCV ELISA kit,1.4%,1.1% and 0.9% were anti HCV E1 positive, respectively.Investigation of seroconversion on three patients showed that anti E1 was first detectable.Conclusion Detection of anti HCV E1 by engineered E1 protein is sensitive and specific.The prevalence and early presence of E1 antibody in HCV infected patients reflect the active status of the disease to a certain extent. Detection of the antibody is useful in clinical diagnosis.