Peking University People's Hospital, Peking University Hepatology Institute, Beijing Key Laboratory of Hepatitis C and Immunotherapy for Liver Diseases, Beijing, China.
Department of Hepatology, Peking University People's Hospital, Beijing, China.
J Gastroenterol Hepatol. 2019 Feb;34(2):458-465. doi: 10.1111/jgh.14405. Epub 2018 Aug 27.
Results obtained from different hepatitis E virus (HEV) tests are usually inconsistent. The detection of serum HEV antigen (Ag) has been suggested to be more sensitive for the diagnosis of genotypes 1 and 3 HEV.
We compared the diagnostic accuracies of serum HEV Ag and HEV RNA by using 202 serum samples from patients suspected acute viral hepatitis.
The HEV Ag assay was 100% specific. The lower detected levels of viremia ranged from 10 to 10 copies/mL. The sensitivity of the HEV Ag test was 90.5%. One of the 42 cases was negative for anti-HEV IgM, but HEV Ag was still detectable. The detectable period of HEV Ag was in concordance with the detectable period of HEV RNA. Serum HEV Ag was persistently detected in two cases of chronic hepatitis E, confirmed by the persistent presence of HEV RNA despite being negative for anti-HEV IgM. HEV Ag demonstrated good consistency with positive HEV RNA (k = 0.938, P < 0.001). Receiver operating characteristic analysis of HEV Ag suggested a second cut-off value of >0.095 to predict HEV patients with 95.24% sensitivity and 98.75% specificity, and the area under the curve was 0.9887, which was higher than that of three commercial anti-HEV IgM ELISA tests.
The presence of HEV Ag has good consistency with HEV RNA in both acute and chronic genotype 4 hepatitis E. HEV Ag is a more promising serum marker to identify active genotype 4 HEV infection than anti-HEV IgM and HEV RNA.
不同的戊型肝炎病毒（HEV）检测结果通常不一致。已有研究表明，血清 HEV 抗原（Ag）检测对于诊断基因型 1 和 3 HEV 更为敏感。
我们比较了 202 例疑似急性病毒性肝炎患者血清中 HEV Ag 和 HEV RNA 的诊断准确性。
HEV Ag 检测法的特异性为 100%。病毒血症的最低检测下限为 10 至 10 拷贝/ml。HEV Ag 检测的敏感性为 90.5%。42 例中有 1 例抗-HEV IgM 阴性，但仍可检测到 HEV Ag。HEV Ag 的检测期与 HEV RNA 的检测期一致。2 例慢性戊型肝炎患者的 HEV Ag 持续存在，尽管抗-HEV IgM 阴性，但 HEV RNA 持续存在，这证实了这一点。HEV Ag 与阳性 HEV RNA 具有良好的一致性（k=0.938，P<0.001）。HEV Ag 的受试者工作特征曲线分析表明，第二个截断值>0.095 可预测 95.24%的 HEV 患者具有敏感性和 98.75%的特异性，曲线下面积为 0.9887，高于三种商业抗-HEV IgM ELISA 检测。
在急性和慢性基因型 4 型戊型肝炎中，HEV Ag 的存在与 HEV RNA 具有良好的一致性。与抗-HEV IgM 和 HEV RNA 相比，HEV Ag 是一种更有前途的血清标志物，可用于识别活跃的基因型 4 HEV 感染。
