Hepatitis E virus serology and PCR: does the methodology matter?

Abstract

Hepatitis E virus (HEV) genotype 3 is an emerging pathogen in the developed world. As the clinical manifestations and routine laboratory parameters are often nonspecific, accurate diagnostic tests are crucial. In the current study, the performance of six serological assays and three PCR assays for the detection of HEV was evaluated. In the setting of the Ghent University Hospital, patients with clinically suspected HEV infection were tested for the presence of HEV IgM and IgG as well as HEV RNA. Serology was performed using six commercial HEV ELISA assays: Biorex, Wantai and Mikrogen IgM and IgG. HEV RNA was detected using one commercial assay (Altona RealStar®), and two optimized in-house real-time RT-PCR assays (according to Jothikumar et al., 2006 and Gyarmati et al., 2007). In addition, all three PCR assays were performed on 16 external quality control (EQC) samples. In a period of 39 months (January 2011-April 2014), 70 patients were enrolled. Using different ELISA assays, the prevalence of antibodies varied from 5.7% to 14.3% for HEV IgM and from 15.7% to 20.0% for IgG. All but two of the results of the PCR assays performed on clinical samples agreed. However, 10 out of 16 EQC samples results showed major discrepancies. We observed important differences in the performance of various serological and PCR assays. For this reason, results of both serological and molecular tests for HEV should be interpreted with caution.

Transmission and Epidemiology of Hepatitis E Virus Genotype 3 and 4 Infections

“…Immunochromatographic tests allowing simple, rapid diagnosis have also been developed (Abravanel et al 2015;Pisanic et al 2017). IgG and IgM immunoblot assays are available, but their clinical relevance has not been established, owing to their lack of sensitivity (Schnegg et al 2013;Cattoir et al 2017).…”

Hepatitis E virus (HEV): seroprevalence and HEV RNA detection in subjects attending a sexually transmitted infection clinic in Brussels, Belgium

“…In a 2011 study performed on 100 randomly selected samples in a hospital of the northern part of the country, seroprevalence was found to be 14% [9]. A recent study performed on limited numbers of hospitalized patients with liver diseases and suspicion of HEV infection found an IgG seroprevalence of 15-20%, depending on the ELISA assay [10].…”

Hepatitis E Virus Genotype 1 and Hepatitis A Virus Dual Infection in Pediatric Patients with a Low Socioeconomic Status from Mexico

“…Even though all of the patients had anti-HEV IgM, larger regions within ORF2 could be amplified in a fraction of them. This inconsistency has been previously observed associated with important differences in the performance of serological and PCR assays [19,20]. In addition, noteworthy differences in the sensitivity and efficiency of detection have been observed among different HEV genome regions [21].…”