Abstract
Hepatitis E virus (HEV) is transfusion-transmissible and therefore poses a risk to blood transfusion safety. Seroprevalence studies are useful for estimating disease burden and determining risk factors. Considerable variability in the sensitivity of HEV antibody detection assays exists. This study aimed to compare the performances of commercially available HEV enzyme-linked immunosorbent assays (ELISA) in Australian blood donor samples. Plasma samples that tested positive (n = 194) or negative (n = 200) for HEV IgG (Wantai HEV IgG ELISA) were selected. Of the 194 HEV IgG positive samples, 4 were positive for HEV IgM (Wantai HEV IgM ELISA). All samples were tested with the MP Diagnostics: HEV IgG ELISA, total (IgG, IgM, and IgA) HEV antibody ELISA, and HEV IgM ELISA. Of the 194 Wantai HEV IgG positive samples, 92 (47%) tested positive with the MP Diagnostics HEV IgG ELISA (κ = 0.47) and 126 (65%) with MP Diagnostics total HEV antibody assay (κ = 0.65). There was poor agreement between Wantai and MP Diagnostics HEV IgM assays. This study demonstrated poor agreement between the assays tested. These observations are consistent with previous reports demonstrating significant variability between HEV ELISAs, highlighting that results of HEV serology should be interpreted with caution.
Highlights
Hepatitis E virus (HEV) is a nonenveloped, RNA virus, classified in the genus Hepevirus of the Hepeviridae family [1]
One of the 200 negative samples with the Wantai HEV IgG assay tested positive with MP Diagnostics HEV IgG enzyme-linked immunosorbent assays (ELISA)
All the Wantai HEV IgG negative samples were negative with MP Diagnostics total HEV antibody assay
Summary
Hepatitis E virus (HEV) is a nonenveloped, RNA virus, classified in the genus Hepevirus of the Hepeviridae family [1]. There are 4 genotypes of HEV [1,2,3,4], representing a single serotype, which infect humans [2]. This classification into genotypes is based on variation in the nucleotides within open reading frame-2 (ORF-2) [3, 4]. HEV causes self-limited acute phase disease with known cases of chronic hepatitis [7]. Chronic HEV infections have been reported in solid-organ transplant recipients [12] and in immune suppressive conditions [13, 14]. A case fatality rate of 0.5–4% has been reported in developing countries [7], which is as high as 10–25% in pregnant women during the third trimester [2, 15, 16]
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