Department of Virology, Institute of Liver & Biliary Sciences (ILBS), Vasant Kunj, New Delhi 110070, India.
J Clin Virol. 2013 Oct;58(2):374-7. doi: 10.1016/j.jcv.2013.07.019. Epub 2013 Aug 9.
Demonstration of active viral replication is important in serologically confirmed cases of hepatitis E virus (HEV) infection to assess prognosis. Detection of HEV RNA by reverse transcriptase polymerase chain reaction (rtPCR) is the gold standard for demonstration of active viremia.
The present study was designed to compare the diagnostic utility of HEV antigen (Ag) with HEV IgM and HEV rtPCR in detecting the active viral replication.
Blood samples from 156 probable cases of acute viral hepatitis (AVH) were collected. Screening for hepatitis B surface antigen (HBsAg), antibody to hepatitis C virus (anti HCV), IgM antibody to hepatitis A virus (HAV IgM) was done on the Architect platform (Abbott Laboratories, IL, USA). HEV IgM ELISA (Wantai Biological, Beijing, China), HEV-Ag ELISA (Wantai Biological, Beijing, China) and HEV rtPCR were done on all the samples.
Out of 156 AVH cases in 56 (35.8%) a diagnosis of HEV was confirmed. Positivity being; anti-HEV IgM 44/56, HEV RNA 20/56, and HEV antigen 17/56 in established cases. Male to female ratio was 3:1. The median age was 40 (range 14-71) years. HEV Ag showed a good concordance with HEV RNA (k=0.635, p<0.001). However HEV IgM did not show any concordance with HEV RNA (k=0.14).
HEV antigen assay can be used as an additional diagnostic marker to confirm active viral replication in serologically positive samples.
在血清学确诊的戊型肝炎病毒（HEV）感染病例中，证明病毒的活跃复制对于评估预后非常重要。逆转录聚合酶链反应（rtPCR）检测 HEV RNA 是证明病毒血症活跃的金标准。
本研究旨在比较 HEV 抗原（Ag）与 HEV IgM 和 HEV rtPCR 在检测活跃病毒复制方面的诊断效用。
收集了 156 例疑似急性病毒性肝炎（AVH）的血样。在 Architect 平台（雅培实验室，伊利诺伊州，美国）上对乙型肝炎表面抗原（HBsAg）、丙型肝炎病毒抗体（抗 HCV）、甲型肝炎病毒 IgM 抗体（HAV IgM）进行了筛查。对所有样本进行了 HEV IgM ELISA（北京万泰生物，中国）、HEV-Ag ELISA（北京万泰生物，中国）和 HEV rtPCR。
在 156 例 AVH 病例中，56 例（35.8%）确诊为 HEV。确诊病例的抗 HEV IgM 阳性率为 44/56，HEV RNA 阳性率为 20/56，HEV 抗原阳性率为 17/56。男女比例为 3:1。中位年龄为 40 岁（范围 14-71 岁）。HEV Ag 与 HEV RNA 具有良好的一致性（k=0.635，p<0.001）。然而，HEV IgM 与 HEV RNA 之间没有一致性（k=0.14）。
HEV 抗原检测可作为血清学阳性样本中确认病毒活跃复制的附加诊断标志物。
