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Diagnostic performance of hepatitis E virus antigen assay in hepatitis E virus acute infection.

Diagnostic performance of hepatitis E virus antigen assay in hepatitis E virus acute infection.
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Lapa D, Brega C, Mammone A, Zaccarelli M, Capobianchi MR, Garbuglia AR,


Lapa D, Brega C, Mammone A, Zaccarelli M, Capobianchi MR, Garbuglia AR, (click to view)

Lapa D, Brega C, Mammone A, Zaccarelli M, Capobianchi MR, Garbuglia AR,

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The new microbiologica 2017 10 1040(4)

Abstract

The aim of this study was to analyze the sensitivity of hepatitis E virus antigen (HEV-Ag) to determine acute E hepatitis. Ninety-four serum samples resulting anti-HEV IgM by DIA.PRO assay were analyzed with Wantai assay to check for HEV-Ag. Thirty samples were anti-HEV IgM positive and HEV-RNA positive, 19 samples harbored genotype 3, whereas 11 samples were genotype 1. Overall, 16% of anti-HEV IgM samples resulted HEV-Ag positive and 33.3% of HEV-RNA positive were also HEV-Ag positive. Among 64 HEV-RNA negative samples, 5 (7.8%) were HEV-Ag positive. The concordance of HEV-RNA and HEV-Ag was low (Cohen’s Kappa=0.36). The Bland-Altman plot revealed a low agreement between HEV-RNA viral load and HEV-Ag, confirmed by a not significant Spearman’s correlation coefficient (rho=0.137, p >0.05). Moreover, the HEV-Ag showed 100% specificity. In genotype 3f samples with a viral load >800cp/ml HEV-Ag was positive in 80% of samples, whereas all patients harboring genotype 3e were HEV-Ag-negative irrespective of HEV-RNA viral load. Among genotype 1, HEV-Ag positivity was observed only in 27.7% patients and in all samples the viremia was >2000 cp/ml. These data suggest that anti-HEV IgM positivity represents the main biological marker of hepatitis E acute infection in clinical real life settings in developed countries.

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