A Comparative Study of Assay Performance of Commercial Hepatitis E Virus Enzyme-Linked Immunosorbent Assay Kits in Australian Blood Donor Samples

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.

Evidence of hepatitis E virus infections among persons who use crack cocaine from the Midwest region of Brazil

“…[16][17][18] The performance of anti-HEV IgG assays may have played a role in the higher seroprevalence of anti-HEV antibodies found in recent studies. 19 Two different studies, both in blood donors, one in Southern Brazil (10%) and other in Southeastern Brazil (9.8%) found similar prevalence to that reported in this study. 17,18 Both of them used the same high sensitivity commercial anti-HEV assays contributed to the similar detection of anti-HEV rates to those observed in this study.…”

“…Currently, data about seroprevalence of HEV infection in Brazil are improving and showing increase of the prevalence . The performance of anti‐HEV IgG assays may have played a role in the higher seroprevalence of anti‐HEV antibodies found in recent studies . Two different studies, both in blood donors, one in Southern Brazil (10%) and other in Southeastern Brazil (9.8%) found similar prevalence to that reported in this study .…”

“…There is no direct evidence that HEV is transmitted by sexual contact, although some studies have shown high seroprevalence of anti‐HEV‐IgG in homosexual men . Persons who use crack spend long periods in drug use settings, they may be more predisposed to acquiring HEV infection through sharing personal utensils with poor hand hygiene allowing the risk of person‐to‐person transmission of infections . Further studies are needed to obtain better insight into various routes of transmission of HEV infection, including sexual route, among people with no stable relationships who use crack.…”

Acute Hepatitis E Virus infection in two geographical regions of Nigeria

“…Additionally, studies have indicated that commercially Journal of Pathogens 3 available ELISA kits for anti-HEV antibodies differ dramatically in their sensitivity and specificity [34][35][36]. In our study, we used an ELISA kit that has been confirmed to have the highest diagnostic sensitivity and specificity when compared to many others by several studies [35,37].…”

HEV seroprevalence in blood donors in Turkey by two commercial total anti‐HEV Ab ELISA kits

“…6 Subsequent studies from Germany, France, Korea, and Australia comparing different enzyme-linked immunosorbent assay (ELISA) kits confirmed the higher sensitivity of the Wantai assay. [7][8][9][10][11][12] In this study, new generation serological assays (Wantai, Beijing, China and Dia.Pro, Milan, Italy) utilizing total anti-HEV antibodies (Ab) based on HEVlike particles, including anti-HEV IgG, immunoglobulin M (IgM) and…”