scholarly journals Evaluation of a Novel CLIA Monotest Assay for the Detection of Anti-Hepatitis E Virus-IgG and IgM: A Retrospective Comparison with a Line Blot and an ELISA

Pathogens ◽  
2021 ◽  
Vol 10 (6) ◽  
pp. 689
Author(s):  
Karl Dichtl ◽  
Julia Zimmermann ◽  
Martin B. Koeppel ◽  
Stephan Böhm ◽  
Andreas Osterman

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.

2011 ◽  
Vol 6 (02) ◽  
pp. 201-203 ◽  
Author(s):  
Vitor Duque ◽  
Conceição Ventura ◽  
Diana Seixas ◽  
Saraiva Da Cunha ◽  
António Meliço-Silvestre

Hepatitis E infection is usually a self-limiting disease. In industrialized countries, sporadic cases of acute hepatitis E virus (HEV) infections have been described; their number seems to be increasing in European countries. We report the first human case of autochthonous acute hepatitis E confirmed in Portugal. Patients with acute non-A-C hepatitis should be tested for HEV in Portugal and hepatitis E infection should be considered in the differential diagnosis of unexplained hepatitis cases.


Animals ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. 277
Author(s):  
Eleonora Chelli ◽  
Elisabetta Suffredini ◽  
Paola De Santis ◽  
Dario De Medici ◽  
Santina Di Bella ◽  
...  

In Europe, foodborne transmission has been clearly associated to sporadic cases and small clusters of hepatitis E in humans linked to the consumption of contaminated pig liver sausages, raw venison, or undercooked wild boar meat. In Europe, zoonotic HEV-genotype 3 strains are widespread in pig farms but little information is available on the prevalence of HEV positive pigs at slaughterhouse. In the present study, the prevalence of HEV-RNA positive pigs was assessed on 585 animals from 4 abattoirs located across Italy. Twenty-one pigs (3.6%) tested positive for HEV in either feces or liver by real-time RT-PCR. In these 21 pigs, eight diaphragm muscles resulted positive for HEV-RNA. Among animals collected in one abattoir, 4 out of 91 plasma tested positive for HEV-RNA. ELISA tests for the detection of total antibodies against HEV showed a high seroprevalence (76.8%), confirming the frequent exposure of pigs to the virus. The phylogenetic analyses conducted on sequences of both ORF1 and ORF2 fragments, shows the circulation of HEV-3c and of a novel unclassified subtype. This study provides information on HEV occurrence in pigs at the slaughterhouse, confirming that muscles are rarely contaminated by HEV-RNA compared to liver, which is the most frequently positive for HEV.


2017 ◽  
Vol 90 (1) ◽  
pp. 142-147 ◽  
Author(s):  
Chenyan Zhao ◽  
Yansheng Geng ◽  
Weijing Huang ◽  
Hongxia Ma ◽  
Youchun Wang

Pathogens ◽  
2020 ◽  
Vol 9 (2) ◽  
pp. 137
Author(s):  
Olympia E. Anastasiou ◽  
Viktoria Thodou ◽  
Annemarie Berger ◽  
Heiner Wedemeyer ◽  
Sandra Ciesek

Introduction: Reliable and cost-effective diagnostics for hepatitis E virus (HEV) infection are necessary. The aim of our study was to investigate which diagnostic test is most accurate to detect HEV infection in immunocompetent and immunosuppressed patients in a real world setting. Patients and Methods: We performed a retrospective analysis of 1165 patients tested for HEV antibodies and HEV PCR at the same time point. Clinical, laboratory and virological data were taken from patient charts. HEV IgA was measured in a subgroup of 185 patients. Results: HEV RNA was detectable in 61 patients (5.2%); most of them (n = 49, 80.3%/n = 43, 70.5%) were HEV IgM+ and IgG+; however, 12 patients (19.6%) were HEV RNA positive/HEV IgM negative and 17 patients (27.8%) were HEV RNA positive/HEV IgG negative. Ten HEV RNA positive patients (16.4%) had neither HEV IgG nor IgM antibodies. Importantly, all of them were immunosuppressed. HEV IgA testing was less sensitive than HEV IgM for HEV diagnosis. Conclusions: HEV infection can be overlooked in patients without HEV specific antibodies. Performing PCR is necessary to diagnose or exclude HEV infection in immunocompromised hosts. In immunocompetent patients, a screening based on HEV antibodies (IgG/IgM) is sufficient.


Author(s):  
X. J. Meng

Hepatitis E virus (HEV) is a small, non-enveloped, single-strand, positive-sense RNA virus of approximately 7.2 kb in size. HEV is classified in the family Hepeviridae consisting of four recognized major genotypes that infect humans and other animals. Genotypes 1 and 2 HEV are restricted to humans and often associated with large outbreaks and epidemics in developing countries with poor sanitation conditions, whereas genotypes 3 and 4 HEV infect humans, pigs and other animal species and are responsible for sporadic cases of hepatitis E in both developing and industrialized countries. The avian HEV associated with Hepatitis-Splenomegaly syndrome in chickens is genetically and antigenically related to mammalian HEV, and likely represents a new genus in the family. There exist three open reading frames in HEV genome: ORF1 encodes non-structural proteins, ORF2 encodes the capsid protein, and the ORF3 encodes a small phosphoprotein. ORF2 and ORF3 are translated from a single bicistronic mRNA, and overlap each other but neither overlaps ORF1. Due to the lack of an efficient cell culture system and a practical animal model for HEV, the mechanisms of HEV replication and pathogenesis are poorly understood. The recent identification and characterization of animal strains of HEV from pigs and chickens and the demonstrated ability of cross-species infection by these animal strains raise potential public health concerns for zoonotic HEV transmission. It has been shown that the genotypes 3 and 4 HEV strains from pigs can infect humans, and vice versa. Accumulating evidence indicated that hepatitis E is a zoonotic disease, and swine and perhaps other animal species are reservoirs for HEV. A vaccine against HEV is not yet available.


2012 ◽  
Vol 140 (10) ◽  
pp. 1838-1847 ◽  
Author(s):  
L. VERHOEF ◽  
M. KOOPMANS ◽  
E. DUIZER ◽  
J. BAKKER ◽  
J. REIMERINK ◽  
...  

SUMMARYHepatitis E virus (HEV) is now considered an endemic pathogen in industrialized countries, leading to acute and sometimes chronic hepatitis, mostly in vulnerable people. The endemic sources are unclear. A survey in The Netherlands in 2006–2007 showed a 1·9% seroprevalence of HEV antibodies measured by ELISA and confirmed by immunoblot in a nationwide sample. Overall, in 134/7072 (1·9%) seropositive individuals, older age (P<0·01), being male (P<0·01), working with patients (P=0·03), working with animals (P=0·07), recent diarrhoeal complaints (P=0·07) and adhering to a religion that considers pigs unclean (P<0·01) were independently associated with seropositivity in multivariate analysis. Sub-analysis of 59/4022 (1·5%) anti-HEV antibody-positive subjects with probable endemic exposure showed independent association with youngest household member being aged <5 years or between 19 and <65 years (P=0·05) in multivariate analysis. These findings may contribute to a better understanding of the sources of endemic HEV exposure, and also highlight the need for systematic epidemiological and serological evaluation of new cases.


2011 ◽  
Vol 156 (8) ◽  
pp. 1451-1454 ◽  
Author(s):  
Santiago Mirazo ◽  
Natalia Ramos ◽  
José C. Russi ◽  
Gustavo Gagliano ◽  
Juan Arbiza

2020 ◽  
Author(s):  
Tiancheng Liu ◽  
Jessica Hsiung ◽  
Su Zhao ◽  
Jessica Kost ◽  
Deepika Sreedhar ◽  
...  

AbstractThe outbreak and rapid spread of SARS-CoV-2 virus has led to a dire global pandemic with millions of people infected and ~ 400,000 deaths thus far. Highly accurate detection of antibodies for COVID-19 is an indispensable part of the effort to combat the pandemic1,2. Here we developed two-plex antibody detection against SARS-CoV-2 spike proteins3 (the S1 subunit and receptor binding domain RBD) in human serum and saliva on a near-infrared nano-plasmonic gold (pGOLD) platform4–8. By testing nearly 600 serum samples, pGOLD COVID-19 assay achieved ~ 99.78 % specificity for detecting both IgG and IgM with 100 % sensitivity in sera collected > 14 days post disease symptom onset, with zero cross-reactivity to other diseases. Two-plex correlation analysis revealed higher binding of serum IgM to RBD than to S1. IgG antibody avidity toward multiple antigens were measured, shedding light on antibody maturation in COVID-19 patients and affording a powerful tool for differentiating recent from remote infections and identifying re-infection by SARS-CoV-2. Just as important, due to high analytical sensitivity, the pGOLD COVID-19 assay detected minute amounts of antibodies in human saliva, offering the first non-invasive detection of SARS-CoV-2 antibodies.


2016 ◽  
Vol 2016 ◽  
pp. 1-6 ◽  
Author(s):  
Ashish C. Shrestha ◽  
Robert L. P. Flower ◽  
Clive R. Seed ◽  
Susan L. Stramer ◽  
Helen M. Faddy

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.


2011 ◽  
Vol 92 (7) ◽  
pp. 1617-1626 ◽  
Author(s):  
Giuseppina La Rosa ◽  
Michele Muscillo ◽  
Valentina Spuri Vennarucci ◽  
Anna Rosa Garbuglia ◽  
Patrizia La Scala ◽  
...  

Human hepatitis E virus (HEV) is considered an emerging pathogen in industrialized countries. The aim of the present study was to contribute to the body of knowledge available on the molecular epidemiology of acute hepatitis E in Italy. Three sets of HEV-specific primers targeting the ORF1 and ORF2 were used to examine serum samples collected from acute hepatitis patients positive for anti-HEV IgG and/or IgM, between 2007 and 2010. Seventeen patients (39.5 %) tested HEV RNA-positive: 12 infections, due to genotype 1, were associated with travel to endemic areas (Bangladesh, India and Pakistan), while five infections, due to genotype 3, were presumably autochthonous. Risk factors identified in this group included exposure to raw seafood, pork liver sausages and wild boar. Results from the present study confirm that human HEV infection in Italy is caused by different genotypes, depending on whether the infection is travel-related or autochthonous.


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