Performance characteristics of the VIDAS® ANTI-HEV IgM and IgG assays

Abravanel, Florence; Goutagny, Nadège; Joffray, Raphaelle; Eichenlaub, Emile; Baron, S.; Aversenq, Alexandre; Bourg, Sandrine; Mercier, Laurence; Triolet, Audrey Larue; Poirault, Didier; Loubet, Marissa; Daniel, Soizic; Luciani, Françoise; Pothion, Catherine; Tourneur, Carole; Dugua, Jean-Marc; Lhomme, Sébastien; Izopet, Jacques

doi:10.1016/j.jcv.2019.01.005

Cited by 17 publications

(9 citation statements)

References 30 publications

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“…In our study, the VIDAS anti-HEV IgG assay was applied for the seroprevalence assessment, while the most used assay in the blood donor seroprevalence studies was the Wantai Elisa test. The analytical and clinical performance of the VIDAS assay has been shown to be excellent [ 38 ], and although some discrepancies in anti-HEV IgG results of individual samples have been seen in comparative studies, the agreement between the VIDAS and Wantai anti-HEV IgG assays has been reported to be good [ 39 ].…”

Section: Discussionmentioning

confidence: 99%

Hepatitis E Virus in Finland: Epidemiology and Risk in Blood Donors and in the General Population

et al. 2023

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Autochthonous hepatitis E (HEV) cases have been increasingly recognized and reported in Europe, caused predominantly by the zoonotic HEV genotype 3. The clinical picture is highly variable, from asymptomatic to acute severe or prolonged hepatitis in immunocompromised patients. The main route of transmission to humans in Europe is the ingestion of undercooked pork meat. Transfusion-transmitted HEV infections have also been reported. The aim of the study was to determine the HEV epidemiology and risk in the Finnish blood donor population. A total of 23,137 samples from Finnish blood donors were screened for HEV RNA from individual samples and 1012 samples for HEV antibodies. Additionally, laboratory-confirmed hepatitis E cases in 2016–2022 were extracted from national surveillance data. The HEV RNA prevalence data was used to estimate the risk of transfusion transmission of HEV in the Finnish blood transfusion setting. Four HEV RNA-positive were found, resulting in 1:5784 (0.02%) RNA prevalence. All HEV RNA-positive samples were IgM-negative, and genotyped samples represented genotype HEV 3c. HEV IgG seroprevalence was 7.4%. From the HEV RNA rate found in this study and data on blood component usage in Finland in 2020, the risk estimate for a severe transfusion-transmitted HEV infection is 1:1,377,000 components or one in every 6–7 years. In conclusion, the results indicate that the risk of transfusion-transmitted HEV (HEV TTI) in Finland is low. However, continuous follow-up of the HEV epidemiology in relation to the transfusion risk landscape in Finland is necessary, as well as promoting awareness in the medical community of the small risk for HEV TTI, especially for immunocompromised patients.

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Section: Discussionmentioning

confidence: 99%

Hepatitis E Virus in Finland: Epidemiology and Risk in Blood Donors and in the General Population

et al. 2023

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“…This ability to detect long-lasting HEV IgM may vary with the serological assay [ 21 ]. We have previously reported that the VIDAS IgM assay is less effective than the Wantai assay for detecting low concentrations of HEV IgM [ 22 ]. The clinical sensitivity of the VIDAS IgM assay was 97.65% for viremic samples (83/85) and 59.15% (42/71) for post-viremic samples from immunocompetent patients.…”

Section: Discussionmentioning

confidence: 99%

“…The clinical sensitivity of the VIDAS IgM assay was 97.65% for viremic samples (83/85) and 59.15% (42/71) for post-viremic samples from immunocompetent patients. It was 78.95% (45/57) for acute phase samples and 77.78% (28/36) for post-viremic samples from immunocompromised patients [ 22 ]. Norder et al found that the DiaPro assay remained positive for the longest time after the onset of an HEV infection [ 17 ].…”

Section: Discussionmentioning

confidence: 99%

“…Two automated HEV serological assays are on the market: the Vidas ® and the Virclia ® instruments. We previously evaluated the Vidas ® anti-HEV IgG and IgM assays (Biomérieux, Marcy-l’Étoile, France); their specificity and sensitivity were excellent [ 22 ]. Similarly, the novel Virclia monotest ® (VirCell, Granada, Spain) hepatitis E IgM and IgG assay is very sensitive for both immunoglobulins (100% for 20 HEV RNA positive samples), but its specificity was not assessed on a large panel of negative samples [ 29 ].…”

Section: Discussionmentioning

confidence: 99%

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Diagnostic Performance of an Automated System for Assaying Anti-Hepatitis E Virus Immunoglobulins M and G Compared with a Conventional Microplate Assay

Abravanel

Parraud

Chapuy‐Regaud

et al. 2022

Viruses

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To evaluate the diagnostic performance of the Liaison® Murex anti-HEV IgM and IgG assays running on the Liaison® instrument and compare the results with those obtained with Wantai HEV assays. We tested samples collected in immunocompetent and immunocompromised patients during the acute (HEV RNA positive, anti-HEV IgM positive) and the post-viremic phase (HEV RNA negative, anti-HEV IgM positive) of infections. The specificity was assessed by testing HEV RNA negative/anti-HEV IgG-IgM negative samples. The clinical sensitivity of the Liaison® IgM assay was 100% for acute-phase samples (56/56) and 57.4% (27/47) for post-viremic samples from immunocompetent patients. It was 93.8% (30/32) for acute-phase (viremic) samples and 71%% (22/31) for post-viremic samples from immunocompromised patients. The clinical sensitivity of the Liaison® IgG assay was 100% for viremic samples (56/56) and 94.6% (43/47) for post-viremic samples from immunocompetent patients. It was 84.3% (27/32) for viremic samples and 93.5% (29/31) for post-viremic samples from immunocompromised patients. Specificity was very high (>99%) in both populations. We checked the limit of detection stated for the Liaison® IgG assay (0.3 U/mL). The clinical performance of the Liaison® ANTI-HEV assays was good. These rapid, automated assays for detecting anti-HEV antibodies will greatly enhance the arsenal for diagnosing HEV infections.

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“…43 Among them, three million cases are symptomatic, and 50 000 to 70 000 deaths are reported. 44 Unlike HAV, HEV antibody prevalence is more challenging to evaluate due to the absence of a gold F I G U R E 2 Current worldwide prevalence of HAV standard, [45][46][47][48] and currently, HEV RNA detection is recommended to complete the diagnosis. 10,47 In spite of this, HEV seroprevalence is constantly rising, linked at least partially to more frequent research.…”

Section: Epidemiology and Distribution Of Genotypesmentioning

confidence: 99%

Emerging hepatitis E virus compared with hepatitis A virus: A new sanitary challenge

Hartard

Gantzer

Bronowicki

et al. 2019

Reviews in Medical Virology

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Summary Hepatitis A (HAV) and E (HEV) viruses are able to cause liver disease in humans. Among the five classical hepatotropic viruses, they are mainly transmitted via the fecal‐oral route. Historically, many similarities have thus been described between them according to their incidence and their pathogenicity, especially in countries with poor sanitary conditions. However, recent advances have provided new insights, and the gap is widening between them. Indeed, while HAV infection incidence tends to decrease in developed countries along with public health improvement, HEV is currently considered as an underdiagnosed emerging pathogen. HEV autochthonous infections are increasingly observed and are mainly associated with zoonotic transmissions. Extra hepatic signs resulting in neurological or renal impairments have also been reported for HEV, as well as a chronic carrier state in immunocompromised patients, arguing in favor of differential pathogenesis between those two viruses. Recent molecular tools have allowed studies of viral genome variability and investigation of links between viral plasticity and clinical evolution. The identification of key functional mutations in viral genomes may improve the knowledge of their clinical impact and is analyzed in depth in the present review.

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Performance characteristics of the VIDAS® ANTI-HEV IgM and IgG assays

Cited by 17 publications

References 30 publications

Hepatitis E Virus in Finland: Epidemiology and Risk in Blood Donors and in the General Population

Hepatitis E Virus in Finland: Epidemiology and Risk in Blood Donors and in the General Population

Diagnostic Performance of an Automated System for Assaying Anti-Hepatitis E Virus Immunoglobulins M and G Compared with a Conventional Microplate Assay

Emerging hepatitis E virus compared with hepatitis A virus: A new sanitary challenge

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