Evaluation of an antigen assay for diagnosing acute and chronic hepatitis E genotype 4 infection.

Abstract:

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 102 to 103  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.

authors

Zhang H,Rao H,Wang Y,Wang J,Kong X,Ji Y,Zhu L,Liu Y,Fang J,Yang M,Luo B,Wang Z,Shi Y,Wang Y,Wang H,Zhao J,Wei L

doi

10.1111/jgh.14405

subject

Has Abstract

pub_date

2019-02-01 00:00:00

pages

458-465

issue

2

eissn

0815-9319

issn

1440-1746

journal_volume

34

pub_type

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