Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology · 2025
Evaluation of urinary hepatitis E virus antigen colloidal gold immunochromatographic assay in clinical diagnosis of hepatitis E virus infection.
СтатьяОценочное исследованиеНазвание и аннотация: Перевод в очереди
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Zhao Conglin, Tao Shuai, Lu Mengxin, Li Weixia, Zhao Han, Sun Shuangshuang, Lin Weijia, Chen Chong, Li Qiang, Huang Yuxian, Chen Liang
Аннотация
BACKGROUND: 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.
OBJECTIVE: To assess the diagnostic performance of the Wantai urinary HEV antigen (Ag) colloidal gold immunochromatographic assay (GICA) in HEV infection.
METHODS: 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.
RESULTS: 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.
CONCLUSION: Urinary HEV Ag GICA demonstrates high diagnostic reliability for acute HEV infection, offering a practical non-invasive option for resource-limited settings.
OBJECTIVE: To assess the diagnostic performance of the Wantai urinary HEV antigen (Ag) colloidal gold immunochromatographic assay (GICA) in HEV infection.
METHODS: 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.
RESULTS: 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.
CONCLUSION: Urinary HEV Ag GICA demonstrates high diagnostic reliability for acute HEV infection, offering a practical non-invasive option for resource-limited settings.