Lapa Daniele, Brega Carla, Mammone Alessia, Zaccarelli Mauro, Capobianchi Maria Rosaria, Garbuglia Anna Rosa
Laboratory of Virology, "Lazzaro Spallanzani" National Institute for Infectious Diseases, IRCCS, Rome, Italy.
Department of Epidemiology, "Lazzaro Spallanzani" National Institute for Infectious Diseases, IRCCS, Rome, Italy.
New Microbiol. 2016 Oct;40(4):246-250. Epub 2017 Oct 10.
The aim of this study was to analyze the sensitivity of hepatitis E virus antigen (HEV-Ag) to determine acute E hepatitis. Ninety-four serum samples resulting anti-HEV IgM by DIA.PRO assay were analyzed with Wantai assay to check for HEV-Ag. Thirty samples were anti-HEV IgM positive and HEV-RNA positive, 19 samples harbored genotype 3, whereas 11 samples were genotype 1. Overall, 16% of anti-HEV IgM samples resulted HEV-Ag positive and 33.3% of HEV-RNA positive were also HEV-Ag positive. Among 64 HEV-RNA negative samples, 5 (7.8%) were HEV-Ag positive. The concordance of HEV-RNA and HEV-Ag was low (Cohen's Kappa=0.36). The Bland-Altman plot revealed a low agreement between HEV-RNA viral load and HEV-Ag, confirmed by a not significant Spearman's correlation coefficient (rho=0.137, p>0.05). Moreover, the HEV-Ag showed 100% specificity. In genotype 3f samples with a viral load >800 cp/ml HEV-Ag was positive in 80% of samples, whereas all patients harboring genotype 3e were HEV-Ag-negative irrespective of HEV-RNA viral load. Among genotype 1, HEV-Ag positivity was observed only in 27.7% patients and in all samples the viremia was >2000 cp/ml. These data suggest that anti-HEV IgM positivity represents the main biological marker of hepatitis E acute infection in clinical real life settings in developed countries.
本研究旨在分析戊型肝炎病毒抗原（HEV-Ag）用于诊断急性戊型肝炎的敏感性。采用万泰检测法对94份经Dia.Pro检测法检测抗HEV IgM呈阳性的血清样本进行分析，以检测HEV-Ag。30份样本抗HEV IgM阳性且HEV-RNA阳性，其中19份样本为3型基因型，11份样本为1型基因型。总体而言，16%的抗HEV IgM样本HEV-Ag呈阳性，33.3%的HEV-RNA阳性样本HEV-Ag也呈阳性。在64份HEV-RNA阴性样本中，5份（7.8%）HEV-Ag呈阳性。HEV-RNA与HEV-Ag的一致性较低（科恩kappa系数=0.36）。布兰德-奥特曼图显示HEV-RNA病毒载量与HEV-Ag之间的一致性较低，斯皮尔曼相关系数不显著（rho=0.137，p>0.05）进一步证实了这一点。此外，HEV-Ag显示出100%的特异性。在病毒载量>800拷贝/毫升的3f型基因型样本中，80%的样本HEV-Ag呈阳性，而所有携带3e型基因型的患者无论HEV-RNA病毒载量如何HEV-Ag均为阴性。在1型基因型中，仅27.7%的患者HEV-Ag呈阳性，且所有样本中的病毒血症均>2000拷贝/毫升。这些数据表明，在发达国家的临床实际环境中，抗HEV IgM阳性是急性戊型肝炎感染的主要生物学标志物。
