HCV IgM抗体检测试剂的研制及其在丙型肝炎检测中的应用

Establishment of a New Method for the Determination of IgM Antibodies to Acute and Chronic Hepatitis C Virus

目的 建立生物素标记HCV多表位嵌合抗原HCV IgM抗体捕获检测方法,探讨在急、慢性丙型肝炎检测中的意义.方法 克隆表达HCV多表位嵌合抗原并标记生物素,链酶亲和素标记HRP,以抗人IgM单克隆抗体包被酶联板,研制出BA-ELISA HCV IgM捕获检测试剂.同时检测68例急性丙型肝炎和20例15～25年慢性丙型肝炎患者及34例健康献血员血清IgG和IgM.结果 68例急性丙型肝炎IgG和IgM检出率分别为97.05%（66/68）和48.53%（33/68）;20例慢性丙型肝炎IgG和IgM检测率分别为100%（20/20）和95%（19/20）.慢性丙型肝炎IgG和IgM 两种检测方法比较差异无统计学意义（P＞0.05）;34例健康献血员血清IgG和IgM特异度均为100%.结论 研制的新型抗HCV IgM检测试剂可用于急、慢性丙型肝炎检测,具有较高的敏感度和特异度.抗-HCV IgM不能作为HCV感染的早期诊断指标,不能区分近期与既往感染,IgM存在时间至少25年.

Objective Based on labeled with biotin HCV multi-epitope complex antigens,Significance of determination of IgM antibodies in Acute and chronic HCV. Methods The HCV multi-epitope complex antigens were expressed in E. coli and labeled with biotin ,Streptavidin labeled with HRP,The plate was coated by IgM McAboThe make preparations ELISA Kit. of anti-HCV IgM. The comparison of both HCV-IgM and IgG antibodies were tested from sera of suffering from acute （n=68）,15-20years （n=20） and sera from control group of healthy individuals （n=34） by ELISA. Results The IgG and IgM antibodies positive rates of 68 with Acute symptomless were respectively 97.05% （66/68） and 48.53% （33/68）. 20 with chronic HCV were respectively 100%（20/20） and 95%（19/20）. The specificity of 34 with healthy individuals of both IgG and IgM were 100%. Conclusion These findings indicate that determination of IgM antibodies to HCV cann＇t marker of the early diagnostic in HCV infection. The existence time of IgM antibodies to HCV were at least more 25 years.