Zhao Conglin, Tao Shuai, Lu Mengxin, Li Weixia, Zhao Han, Sun Shuangshuang, Lin Weijia, Chen Chong, Li Qiang, Huang Yuxian, Chen Liang
Department of Liver Disease, Shanghai Public Health Clinical Center, Fudan University, Shanghai 200000, China.
Scientific Research Center, Shanghai Public Health Clinical Center, Fudan University, Shanghai 200000, China.
J Clin Virol. 2025 Aug;179:105825. doi: 10.1016/j.jcv.2025.105825. Epub 2025 Jun 11.
Hepatitis E virus (HEV) is a significant public health concern worldwide. Current diagnostic methods for HEV infection have limitations in terms of accessibility and timeliness.
To assess the diagnostic performance of the Wantai urinary HEV antigen (Ag) colloidal gold immunochromatographic assay (GICA) in HEV infection.
This prospective study enrolled 150 patients with suspected acute hepatitis E and 50 healthy controls. Paired urine, fecal, and serum samples were collected during initial clinical evaluation. Serum and fecal HEV RNA levels were quantified via reverse transcription-quantitative polymerase chain reaction (RT-qPCR), with genotyping performed by nested RT-PCR. Serum anti-HEV IgM/IgG levels were measured by Enzyme-Linked Immunosorbent Assay (ELISA), and urinary HEV antigen was detected using GICA. Diagnostic accuracy metrics were calculated against the reference standard of HEV RNA detection.
HEV RNA was detected in 58 % (87/150) of suspected cases. All successfully genotyped cases (69 %, 60/87) were HEV genotype 4. All healthy controls tested negative for HEV RNA and urinary HEV Ag.The urinary HEV Ag GICA showed 98.9 % sensitivity and 87.6 % specificity, with high concordance with RT-qPCR (Kappa = 0.85). Longitudinal follow-up revealed viral clearance and liver function normalization in most patients within 3-4 weeks post-symptom onset. 85.7 % of patients achieved urinary HEV Ag negative conversion within 6-7 weeks, while anti-HEV IgM remained positive in all patients at follow-up conclusion.
Urinary HEV Ag GICA demonstrates high diagnostic reliability for acute HEV infection, offering a practical non-invasive option for resource-limited settings.
戊型肝炎病毒（HEV）是全球重大的公共卫生问题。目前戊型肝炎病毒感染的诊断方法在可及性和及时性方面存在局限性。
评估万泰尿戊型肝炎病毒抗原（Ag）胶体金免疫层析法（GICA）在戊型肝炎病毒感染中的诊断性能。
这项前瞻性研究纳入了150例疑似急性戊型肝炎患者和50例健康对照。在初始临床评估期间收集配对的尿液、粪便和血清样本。通过逆转录定量聚合酶链反应（RT-qPCR）对血清和粪便中的戊型肝炎病毒RNA水平进行定量，并通过巢式RT-PCR进行基因分型。采用酶联免疫吸附测定（ELISA）检测血清抗戊型肝炎病毒IgM/IgG水平，并使用GICA检测尿戊型肝炎病毒抗原。根据戊型肝炎病毒RNA检测的参考标准计算诊断准确性指标。
58%（87/150）的疑似病例检测到戊型肝炎病毒RNA。所有成功进行基因分型的病例（69%，60/87）均为戊型肝炎病毒基因型4。所有健康对照的戊型肝炎病毒RNA和尿戊型肝炎病毒抗原检测均为阴性。尿戊型肝炎病毒抗原GICA的灵敏度为98.9%，特异度为87.6%，与RT-qPCR高度一致（Kappa=0.85）。纵向随访显示，大多数患者在症状出现后3-4周内病毒清除且肝功能恢复正常。85.7%的患者在6-7周内尿戊型肝炎病毒抗原转阴，而随访结束时所有患者的抗戊型肝炎病毒IgM仍为阳性。
尿戊型肝炎病毒抗原GICA对急性戊型肝炎病毒感染具有较高的诊断可靠性，为资源有限的环境提供了一种实用的非侵入性选择。
