Abstract
Despite the increasing relevance of Hepatitis E, an emerging disease endemic in developing and with increasing numbers of sporadic cases in industrialized countries, commercial tests are mainly based on batch oriented serological assays. In this retrospective study, we compared a line immunoassay (LIA; recomLine HEV, Mikrogen) and an ELISA (EIA; Anti-Hepatitis E Virus ELISA, Euroimmun) with a novel chemoluminescence immunoassay in a monotest format (CLIA; Hepatitis E VirClia, Vircell). Twenty sera of PCR proven cases of hepatitis E and 68 blood samples serologically pre-characterized were included. Applying the WHO reference standard, the CLIA demonstrated the highest analytical sensitivity for IgG and IgM. The combinations of CLIA/EIA (IgG and IgM) and CLIA/LIA (IgG) measurements showed substantial correlation. Compared to overall antibody detection (seropositivity in ≥2 assays), CLIA correlation was excellent, outperforming LIA (IgM) and EIA (IgG and IgM). Minor IgM cross reactivity in samples of patients with acute EBV infection was observed in all three assays. The CLIA showed good performance in diagnostic samples compared to established LIA and EIA assays. Due to its ready-to-use monotest format, the CLIA allows simple, time- and cost-effective handling of single samples. These qualities make the assay suitable for diagnostics, especially in the emergency setting and for low-throughput laboratories.
Highlights
Hepatitis E virus (HEV) is—besides the Hepatitis A virus (HAV)—the most important pathogen of enterically transmitted infectious hepatitis worldwide
In this study we aimed to evaluate the performance of a novel, CE certified indirect chemiluminescence immunoassay for the detection of IgG and IgM antibodies against HEV, i.e., the Hepatitis E Virclia monotest (VirCell, Granada, Spain; chemoluminescence immunoassay in a monotest format (CLIA))
Differences in analytical sensitivities of the three anti-HEV IgG and IgM assays were detected by serial dilutions of the world health organization (WHO) Standard (Figure 1 and supplementary Table S1)
Summary
Hepatitis E virus (HEV) is—besides the Hepatitis A virus (HAV)—the most important pathogen of enterically transmitted infectious hepatitis worldwide. Hepatitis A seems, at first glance, to outclass hepatitis E with an incidence of more than 100 million cases every year (HEV: 20 million) [1,2]. Hepatitis E is associated with higher morbidity and mortality rates (3 million symptomatic infections and 70,000 fatal courses per year). This demonstrates the significant impact of HEV for health care systems worldwide [1,3]. The four relevant human-transmissible HEV genotypes (GT 1–4) can be divided into two groups with different characteristics, such as their geographical distribution and route of transmission. GT 1 and GT 2 infect several million people each year in Asia and Africa [3]
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