{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,10]],"date-time":"2026-07-10T00:27:20Z","timestamp":1783643240337,"version":"3.55.0"},"reference-count":40,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2025,12,15]],"date-time":"2025-12-15T00:00:00Z","timestamp":1765756800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2025,12,15]],"date-time":"2025-12-15T00:00:00Z","timestamp":1765756800000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"funder":[{"DOI":"10.13039\/100016545","name":"Roche Diagnostics","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100016545","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Liver International"],"published-print":{"date-parts":[[2026,1]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background &amp; Aims<\/jats:title>\n                    <jats:p>Hepatitis E virus (HEV) is the leading cause of acute viral hepatitis. We evaluated the performance of the new automated Elecsys Anti\u2010HEV IgG and Elecsys Anti\u2010HEV IgM assays (Roche Diagnostics) in detecting acute, recent and past HEV infection.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      Performance of the Elecsys assays relative to three commercially available CE\u2010IVD anti\u2010HEV assays was assessed in a large multinational cohort (six laboratories in Germany, Austria and China). Sensitivity testing included samples from patients with presumed acute (IgM:\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u2009707; IgG:\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u2009490) and recovered HEV infection (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u2009156). Specificity testing included samples from asymptomatic blood donors (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u20095040), routine diagnostic samples (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u20092427), and pregnant women (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u2009544). An in\u2010house anti\u2010HEV IgG neutralisation method was performed to resolve discrepant specificity sample results. Seroconversion sensitivity analysis was performed using nine commercial seroconversion panels (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u2009119 samples).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Relative sensitivity and specificity of the Elecsys assays were &gt;\u200998.6% (95% CI: 92.2%\u2013100%) and &gt;\u200998.9% (98.4%\u201399.2%) for anti\u2010HEV IgM and &gt;\u200981.2% (79.3%\u201383.0%) for anti\u2010HEV IgG in different cohorts, respectively. After confirming anti\u2010HEV IgG in 680\/696 discrepant samples by a neutralisation method, relative specificity of the Elecsys Anti\u2010HEV IgG assay was &gt;\u200999.4% (98.8%\u201399.7%). Evaluation of commercial seroconversion panels showed good overall agreement between the assays.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>The Elecsys Anti\u2010HEV IgG and IgM assays showed favourable overall performance when compared to three commercially available CE\u2010IVD marked assays. Neutralisation data indicated higher sensitivity of the Elecsys Anti\u2010HEV IgG assay than comparator assays in detecting past infections and lower IgG concentrations.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/liv.70480","type":"journal-article","created":{"date-parts":[[2025,12,15]],"date-time":"2025-12-15T13:03:11Z","timestamp":1765803791000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Performance of Elecsys Anti\u2010\n                    <scp>HEV IgG<\/scp>\n                    and\n                    <scp>IgM<\/scp>\n                    Assays for the Detection of Acute, Recent or Past Hepatitis E Virus Infection"],"prefix":"10.1111","volume":"46","author":[{"given":"Mathias","family":"Schemmerer","sequence":"first","affiliation":[{"name":"National Consultant Laboratory for HAV and HEV, Institute of Clinical Microbiology and Hygiene University Medical Center Regensburg  Regensburg 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