戊型肝炎IgM抗体诊断试剂的临床应用评价

Evaluation of clinical diagnosis reliability of two ELISA kits for detecting IgM-class antibody against hepatitis E virus

目的评价2种戊型肝炎病毒（HEV）IgM抗体诊断试剂的可靠性。方法用捕获法试剂（E2 IgM）和间接法试剂（GL IgM）对349例临床诊断为急性戊型肝炎及急性非甲~戊型肝炎患者的血清进行HEV IgM检测。同时结合其HEV RNA检测结果作为戊型肝炎的确认标准,以此为依据对2种HEV IgM诊断试剂和以往常用的ELISA试剂的可靠性进行评估。同时检测69例散发性急性肝炎患者血清的HEV IgM及甲型肝炎病毒（HAV）IgM,分析HAV IgM对HEV IgM检测可能造成的干扰。结果E2 IgM试剂的敏感性为98.2%,特异性为100.0%;GL IgM试剂的敏感性仅为60.0%,特异性为91.7%;而传统诊断方法的敏感性为77.9%,特异性仅66.0%,三者差异有统计学意义（P〈0.05）。E2 IgM、GL IgM及传统诊断方法的总符合率分别为99.1%、85.5%和70.5%。HAV IgM有可能导致GL IgM试剂的假阳性。结论E2 IgM试剂是一种良好的戊型肝炎急性诊断试剂,在临床应用中优于GL IgM试剂和传统诊断方法。

Objective To evaluate the reliability of two enzyme-linked immunosorbent assay（ELISA） kits for detecting IgM-class antibody against hepatitis E virus（HEV）. Methods IgM antibody against HEV was detected by μ-chain capture ELISA（E2 IgM） and indirect ELISA（GL IgM） in sera from 349 patients formerly diagnosed as acute hepatitis E or non A to E hepatitis by other ELISA HEV kits.The results,combined with HEV RNA detection result,were used to confirm or exclude the diagnosis of hepatitis E.In order to evaluate the possibility of interference on HEV IgM detection by hepatitis A virus（HAV） IgM,both of the antibodies were also detected in sera from 69 patients with acute hepatitis. Results The sensitivity of E2 IgM,GL IgM and traditional method were 98.2%,60.0% and 77.9% respectively（P〈（0.05））.The specificity of E2 IgM GL IgM,and traditional method were 100.0%,99.1% and 66.0% respectively（P〈（0.05））.In summary,the accordant rates of E2 IgM,GL IgM and traditional method were 99.1%,85.5% and 70.5% respectively. Conclusions E2 IgM is a reliable reagent for diagnosing acute hepatitis E,and better than GL IgM and traditional method in clinical application.