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Evaluation of an antigen assay for diagnosing acute and chronic hepatitis E genotype 4 infection
Author(s) -
Zhang Haiying,
Rao Huiying,
Wang Yijin,
Wang Jianghua,
Kong Xiangsha,
Ji Ying,
Zhu Ling,
Liu Yan,
Fang Jilian,
Yang Ming,
Luo Bifen,
Wang Zhenyu,
Shi Yijun,
Wang Yu,
Wang Hao,
Zhao Jingmin,
Wei Lai
Publication year - 2019
Publication title -
journal of gastroenterology and hepatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.214
H-Index - 130
eISSN - 1440-1746
pISSN - 0815-9319
DOI - 10.1111/jgh.14405
Subject(s) - hepatitis e virus , medicine , virology , genotype , hepatitis e , immunology , biology , gene , biochemistry
Background and Aim 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. Methods We compared the diagnostic accuracies of serum HEV Ag and HEV RNA by using 202 serum samples from patients suspected acute viral hepatitis. Results The HEV Ag assay was 100% specific. The lower detected levels of viremia ranged from 10 2 to 10 3 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. Conclusions 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.