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

2016 ◽  
Vol 2016 ◽  
pp. 1-6 ◽  
Author(s):  
Ashish C. Shrestha ◽  
Robert L. P. Flower ◽  
Clive R. Seed ◽  
Susan L. Stramer ◽  
Helen M. Faddy
Keyword(s):  
Blood Donor ◽  
Disease Burden ◽  
Hepatitis E Virus ◽  
Hepatitis E ◽  
Antibody Detection ◽  
Enzyme Linked Immunosorbent Assay ◽  
Poor Agreement ◽  
Igm Elisa ◽  
Assay Performance ◽  
Antibody Elisa

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.

scholarly journals Diagnostic Performance of Three Serological Assays for Anti-SARS-CoV-2 Antibody Detection

2021 ◽  
Vol 5 (4) ◽  
pp. 162-165
Author(s):  
Shabnam Dildar ◽  
◽  
Asma Danish ◽  
Mehjabeen Imam ◽  
Arshi Naz ◽  
...  
Keyword(s):  
Immunosorbent Assay ◽  
Diagnostic Performance ◽  
Immunofluorescence Assay ◽  
Lateral Flow ◽  
Antibody Detection ◽  
Enzyme Linked Immunosorbent Assay ◽  
Perfect Agreement ◽  
N Protein ◽  
Assay Performance ◽  
Antibody Elisa

Abstract: Objective: To evaluate the diagnostic performance of Electrochemiluminescence (ECLIA) enzyme linked immunosorbent (ELISA) and lateral flow Immunofluorescence (LFIA) for anti-SARS-COV-2 antibody detection. Materials and Methods: Sensitivity was calculated with convalescent plasma (CP) donor’s samples. Specificity was checked by using pre-pandemic October 2019 samples. All samples were tested for anti-SARS-COV-2 antibody by using Electrochemiluminescence (ECLIA), Enzyme Linked Immunosorbent Assay (ELISA) and Lateral flow Immunofluorescence (LFIA) assay. Results: Total 55 patients were included, 45 patients were CP donors and 10 were Pre-Pandemic October 2019 samples archived from our blood bank. The ECLIA-total antibody, ELISA-IgG and LLFIA-IgG were positive in 41 (91.1%), 34 (75.5%) and 44 (97.75%) respectively. The highest sensitivity was observed for LFIA with highest specificity among all three assays. There was almost perfect agreement between LFIA and ECLIA (k=0.936, p<0.001) but there was fair agreement between LFIA and ELISA (k=0.412, p=0.001) and ECLIA and ELISA (k=0.357, p=0.001). Conclusion: The LFIA showed a higher sensitivity and specificity in comparison with ECLIA and ELISA. It might be due to fact that LFIA detect antibody against ncleocapsid and spike protein as well of SARS- COV-2 virus, while ECLIA and ELISA detects antibodies only against “N” Protein of SARS- COV-2 virus. Keywords: Convalescent plasma donors, Lateral flow Immunofluorescence assay, Electrochemiluminescence assay, Enzyme linked immunosorbent assay, Performance.

Hepatitis E virus blood donor NAT screening: as much as possible or as much as needed?

Transfusion ◽  
2018 ◽  
Vol 59 (2) ◽  
pp. 612-622 ◽  
Author(s):  
T. Vollmer ◽  
J. Diekmann ◽  
C. Knabbe ◽  
J. Dreier
Keyword(s):  
Blood Donor ◽  
Hepatitis E Virus ◽  
Hepatitis E

Valuable antibody detection method for classifying hepatitis E virus genotypes

2017 ◽  
Vol 90 (1) ◽  
pp. 142-147 ◽  
Author(s):  
Chenyan Zhao ◽  
Yansheng Geng ◽  
Weijing Huang ◽  
Hongxia Ma ◽  
Youchun Wang
Keyword(s):  
Hepatitis E Virus ◽  
Detection Method ◽  
Hepatitis E ◽  
Antibody Detection ◽  
Virus Genotypes

scholarly journals DESIGN OF HEPATITIS E VIRUS GENOTYPE 1 RECOMBINANT ORF3 PROTEIN BY CODON OPTIMIZATION METHOD

2017 ◽  
pp. 63-72
Author(s):  
G. I. Alatortseva ◽  
A. V. Sidorov ◽  
L. N. Nesterenko ◽  
L. N. Luhverchik ◽  
M. V. Zhukina ◽  
...  
Keyword(s):  
Recombinant Protein ◽  
Hepatitis E Virus ◽  
Optimization Method ◽  
Hepatitis E ◽  
Antigenic Specificity ◽  
Clinical Samples ◽  
Enzyme Linked Immunosorbent Assay ◽  
Genotype 1 ◽  
Recombinant Polypeptide ◽  
Full Size

Aim. The development of the hepatitis E virus (HEV) genotype 1 full-size ORF3 recombinant polypeptide. Materials and methods. Escherichia coli strains, plasmid vectors, serological and clinical samples, ELISA reagent kits, molecular biological, bioinformatic, biotechnological, biochemical and serological methods. Results. HEV genotype 1 RNA had been isolated from clinical samples collected in Kyrgyzstan. DNA copy of subgenomic virus RNA had been cloned and used for further development of E.coli strains producing full-size recombinant protein ORF3 fused to E.coli beta-galactosidase. Codons optimization method was used in aim to increase expression level of recombinant protein. Recombinant protein ORF3 had been isolated from the inclusion bodies of the E.coli biomass and purified by size exclusion chromatography. Antigenic specificity of recombinant polypeptide had been confirmed by enzyme-linked immunosorbent assay and Western blotting with the specific sera. Conclusion. HEVgenotype 1 ORF3 recombinant antigen had been designed, and it’s applicability in diagnostic tests had been experimentally confirmed.

Serological and Molecular Investigation of Swine Hepatitis E Virus in Pigs Raised in Southern Italy

2015 ◽  
Vol 78 (11) ◽  
pp. 2099-2102 ◽  
Author(s):  
NICOLA COSTANZO ◽  
ELEONORA SARNO ◽  
VINCENZO PERETTI ◽  
LUCIA CIAMBRONE ◽  
FRANCESCO CASALINUOVO ◽  
...  
Keyword(s):  
Hepatitis E Virus ◽  
Southern Italy ◽  
Age Groups ◽  
Hepatitis E ◽  
Developed Countries ◽  
Oral Route ◽  
Enzyme Linked Immunosorbent Assay ◽  
Viral Genomes ◽  
Reverse Transcription Pcr ◽  
Significant Difference

Hepatitis E virus (HEV) infection is a common acute hepatitis transmitted by the fecal-oral route. In developed countries, the virus has a zoonotic potential, and domestic pigs and wild boars are considered main reservoirs. To assess the prevalence of HEV-positive animals in the Calabria region (southern Italy) on a serological and molecular level, a total of 216 autochthonous healthy pigs (Apulo-Calabrese breed) were sampled. Both sera and feces were collected. Pigs were grouped based on age: 117 pigs &lt;6 months and 99 pigs &gt;6 months. By using a commercial enzyme-linked immunosorbent assay system, a total of 173 (80%) of the 216 pigs tested seropositive. In all sampled farms (n = 8), pigs with antibodies (immunoglobulin G) against HEV were detected at a level higher than 60%, with a significant difference among age groups (P &lt; 0.0001). Moreover, 16 fattening pigs were found to be nested reverse transcription PCR positive and thus to shed viral genomes in their feces. These positive findings resulted in a prevalence of 48.4% on the farm level (16 of 35 pigs) and an overall prevalence of 7.4% at the animal level (16 of 216 pigs). Based on the present study, HEV seems to circulate among the autochthonous domestic pig population of southern Italy with a low sharing rate. Further studies exploring the origin of infection are needed to minimize the risk of human exposure and to reduce consequences for public health.

scholarly journals Hepatitis E virus (HEV) in Scotland: evidence of recent increase in viral circulation in humans

2018 ◽  
Vol 23 (12) ◽  
Author(s):  
Katrina Thom ◽  
Pamela Gilhooly ◽  
Karen McGowan ◽  
Kristen Malloy ◽  
Lisa M Jarvis ◽  
...  
Keyword(s):  
Blood Donor ◽  
Hepatitis E Virus ◽  
Hepatitis E ◽  
Transplant Recipients ◽  
Genotype 3 ◽  
Transplant Patients ◽  
Low Threshold ◽  
Low Levels ◽  
Clade 1 ◽  
Liver Transplant Recipients

Background Previous studies showed low levels of circulating hepatitis E virus (HEV) in Scotland. We aimed to reassess current Scottish HEV epidemiology. Methods: Blood donor samples from five Scottish blood centres, the minipools for routine HEV screening and liver transplant recipients were tested for HEV antibodies and RNA to determine seroprevalence and viraemia. Blood donor data were compared with results from previous studies covering 2004–08. Notified laboratory-confirmed hepatitis E cases (2009-16) were extracted from national surveillance data. Viraemic samples from blood donors (2016) and chronic hepatitis E transplant patients (2014–16) were sequenced. Results: Anti-HEV IgG seroprevalence varied geographically and was highest in Edinburgh where it increased from 4.5% in 2004–08) to 9.3% in 2014–15 (p = 0.001). It was most marked in donors < 35 years. HEV RNA was found in 1:2,481 donors, compared with 1:14,520 in 2011. Notified laboratory-confirmed cases increased by a factor of 15 between 2011 and 2016, from 13 to 206. In 2011–13, 1 of 329 transplant recipients tested positive for acute HEV, compared with six cases of chronic infection during 2014–16. Of 10 sequenced viraemic donors eight and all six patients were infected with genotype 3 clade 1 virus, common in European pigs. Conclusions: The seroprevalence, number of viraemic donors and numbers of notified laboratory-confirmed cases of HEV in Scotland have all recently increased. The causes of this change are unknown, but need further investigation. Clinicians in Scotland, particularly those caring for immunocompromised patients, should have a low threshold for testing for HEV.

scholarly journals Low Hepatitis E Virus Prevalence Among Blood Donor in Dali in China

2020 ◽  
Author(s):  
Ping Fu ◽  
Baochai Lin ◽  
Bingting Wu ◽  
Ling Ke ◽  
Tianfu Yang ◽  
...  
Keyword(s):  
Blood Transfusion ◽  
Ethnic Minority ◽  
Odds Ratio ◽  
Hepatitis E Virus ◽  
Blood Donors ◽  
Hepatitis E ◽  
Enzyme Linked Immunosorbent Assay ◽  
Serum Samples ◽  
Iga Antibodies ◽  
Positive Rate

Abstract BACKGROUND: Hepatitis E virus (HEV) is a nonenveloped RNA virus causing Hepatitis E worldwide. An increasing transfusion transmission cases of HEV infections from asymptomatic blood donors which causing serious illnesses in immunosuppressed recipients have been reported in the past few years. China is one of the highly prevalent regions of HEV, it is important to evaluate the risk of HEV transmission from blood transfusion. METHODS: A total of 1864 serum samples from blood donors and demographic characteristics were randomly collected from Feb to Mar 2018 in Dali city. Anti-HEV IgG, IgM and IgA antibodies and HEV antigen were examined by enzyme-linked immunosorbent assay (ELISA). HEV RNA was detected by real-time PCR. Multivariable logistic regression modelling was used to examine risk factors associated with HEV prevalence.RESULTS: Overall, the positive rate of anti-HEV IgG, IgM, and IgA antibodies was 13.36% (249/1864), 1.13%(21/1864), and 1.82%(34/1864), respectively. However, none of the 1864 serum samples was detected as HEV antigen-positive nor HEV RNA positive. The positive rate of anti-HEV IgG antibody is high as 28.57% (2/7) in the donors with isolated elevated alanine aminotransferase (ALT). Females (16.69%) had a significantly higher HEV seroprevalence than males (13.04%) (odds ratio [OR]: 1.34 [95% CI, 1.02-1.75]). Other ethnic minority (24.32%) and Bai (18.85%) donors had a significantly higher HEV seroprevalence when compared to Han (12.21%) blood donors (odds ratio [OR], 2.25 [95% CI, 1.04-4.88] for other ethnic minority, 1.65 [95% CI, 1.24-2.19] for Bai). Conclusions: Dali, Yunnan province, China is an endemic region for HEV and have a relatively low risk of HEV transmission via blood transfusion. Whether to formulate the strategy for HEV screening in blood center needed further researched.

scholarly journals Detection of Hepatitis E Virus-Specific Immunoglobulin A in Patients Infected with Hepatitis E Virus Genotype 1 or 3

2007 ◽  
Vol 14 (3) ◽  
pp. 276-280 ◽  
Author(s):  
M. Herremans ◽  
E. Duizer ◽  
E. Jusic ◽  
M. P. G. Koopmans
Keyword(s):  
Acute Hepatitis ◽  
Hepatitis E Virus ◽  
Hepatitis E ◽  
Immunoglobulin M ◽  
Enzyme Linked Immunosorbent Assay ◽  
Control Group ◽  
Genotype 1 ◽  
Genotype 3 ◽  
Route Of Transmission

ABSTRACT Currently, diagnosis of acute hepatitis E virus (HEV) in patients is primarily based on anti-HEV immunoglobulin M (IgM) detection. However, several investigations suggest the use of HEV-specific IgA for diagnosing acute HEV infections. We evaluated two commercially available assays, an IgA enzyme-linked immunosorbent assay (ELISA) (Diacheck) and an adapted immunoblot protocol (Mikrogen) for IgA detection and compared the performance in genotype 1- and 3-infected patients. The specificity of the IgA assays was high, with no positive reactions in a control group of 18 acute hepatitis patients who were negative for HEV. The sensitivity calculated in nine PCR-positive type 1-infected patients was 100% in both assays but was clearly lower in genotype 3-infected patients (n = 14), with sensitivities of only 67% and 57% for the ELISA and immunoblot assay, respectively. The lower IgA responses detected in genotype 3-infected patients could be caused by the use of only the genotype 1 and 2 antigens in the serological assays. Interestingly in two patients with possible infection through blood transfusion no response or intermediate IgA responses were detected, and this might confirm the parenteral route of transmission. In both the type 1- and type 3-infected patients both the IgA and IgM responses disappeared simultaneously. We conclude that IgA detection is of limited value for the serodiagnosis of acute HEV cases, particularly with genotype 3.

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