{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,19]],"date-time":"2026-08-19T05:25:20Z","timestamp":1787117120226,"version":"build-2736575974"},"reference-count":35,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2026,8,19]],"date-time":"2026-08-19T00:00:00Z","timestamp":1787097600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Cell. Infect. Microbiol."],"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Hepatitis B e antigen (HBeAg) and its corresponding antibody (anti-HBe) serve as critical serological markers in the evaluation and therapeutic management of Hepatitis B virus (HBV) infection.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Study design<\/jats:title>\n                    <jats:p>This retrospective study was designed to evaluate the performance of the newly CE-marked MAGLUMI HBeAg (CLIA) and MAGLUMI Anti-HBe (CLIA) assays by comparing with Abbott Architect HBeAg and Abbott Architect Anti-HBe assays, respectively. Analytical performance was verified in compliance with the guidelines issued by the Clinical and Laboratory Standards Institute (CLSI). Negative and positive specimens were collected to determine negative percent agreement (NPA) and positive percent agreement (PPA) respectively. Analytical specificity was assessed using negative samples containing potentially cross-reacting substances. Additionally, analytical sensitivity was evaluated using 1st WHO International Standard.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>The claimed performance specifications for LoB, LoD, linearity, and precision were successfully verified. Both MAGLUMI HBeAg (CLIA) and MAGLUMI Anti-HBe (CLIA) assays exhibited satisfactory NPA and PPA (\u226598%). No significant cross-reactivity or interference was observed. Furthermore, all tested plasma matrices demonstrated equivalence to serum in both assays.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>The MAGLUMI HBeAg (CLIA) and MAGLUMI Anti-HBe (CLIA) met the CLIS verification criteria with favorable analytical performance, and achieved high NPA and PPA relative to the Abbott Architect comparative assays. Besides, future concordance assessments based on a large intended cohort, together with independent clinical validation, are required to fully confirm their suitability for routine clinical application and management of HBV infection.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.3389\/fcimb.2026.1867239","type":"journal-article","created":{"date-parts":[[2026,8,19]],"date-time":"2026-08-19T04:38:27Z","timestamp":1787114307000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":0,"title":["Analytical performance evaluation of MAGLUMI HBeAg and anti-HBe chemiluminescence immunoassays and comparison with the Abbott assays"],"prefix":"10.3389","volume":"16","author":[{"given":"Jingfeng","family":"Zeng","sequence":"first","affiliation":[{"name":"Blood Screening Department, Shenzhen Blood Center","place":["Shenzhen, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xin","family":"Zhao","sequence":"additional","affiliation":[{"name":"Medical Research and Laboratory Diagnostic Center, Jinan Central Hospital Affiliated to Shandong First Medical University","place":["Jinan, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wenfeng","family":"Wang","sequence":"additional","affiliation":[{"name":"Research & Development Department, Shenzhen New Industries Biomedical Engineering Co., Ltd. (Snibe)","place":["Shenzhen, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ju","family":"Wang","sequence":"additional","affiliation":[{"name":"Blood Screening Department, Shenzhen Blood Center","place":["Shenzhen, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ximiao","family":"Li","sequence":"additional","affiliation":[{"name":"Blood Screening Department, Shenzhen Blood Center","place":["Shenzhen, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kaize","family":"Zheng","sequence":"additional","affiliation":[{"name":"Research & Development Department, Shenzhen New Industries Biomedical Engineering Co., Ltd. (Snibe)","place":["Shenzhen, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hongwei","family":"Zhang","sequence":"additional","affiliation":[{"name":"Research & Development Department, Shenzhen New Industries Biomedical Engineering Co., Ltd. (Snibe)","place":["Shenzhen, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jun","family":"Yin","sequence":"additional","affiliation":[{"name":"Research & Development Department, Shenzhen New Industries Biomedical Engineering Co., Ltd. (Snibe)","place":["Shenzhen, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zhonggang","family":"Fang","sequence":"additional","affiliation":[{"name":"Research & Development Department, Shenzhen New Industries Biomedical Engineering Co., Ltd. (Snibe)","place":["Shenzhen, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1965","published-online":{"date-parts":[[2026,8,19]]},"reference":[{"key":"B1","doi-asserted-by":"publisher","first-page":"199","DOI":"10.1016\/s0022-1759(01)00362-3","article-title":"Polyreactivity is not an artefact","volume":"254","author":"Bouvet","year":"2001","journal-title":"J. Immunol. Methods"},{"key":"B2","doi-asserted-by":"publisher","first-page":"793","DOI":"10.1016\/j.jhep.2018.11.023","article-title":"Quantitation of anti-HBe antibodies in anti-HBc-positive liver donors","volume":"70","author":"Caviglia","year":"2019","journal-title":"J. Hepatol."},{"key":"B3","doi-asserted-by":"publisher","first-page":"160","DOI":"10.1016\/j.siny.2007.01.013","article-title":"Hepatitis B virus infection","volume":"12","author":"Chang","year":"2007","journal-title":"Semin. Fetal Neonatal Med."},{"key":"B4","doi-asserted-by":"publisher","first-page":"79","DOI":"10.1007\/s12072-016-9734-5","article-title":"Molecular mechanisms of HBeAg in persistent HBV infection","volume":"11","author":"Chen","year":"2017","journal-title":"Hepatol. Int."},{"key":"B5","doi-asserted-by":"publisher","first-page":"3016","DOI":"10.1111\/liv.12749","article-title":"Immune tolerance split between hepatitis B virus precore and core proteins","volume":"79","author":"Chen","year":"2005","journal-title":"J. Virol."},{"key":"B6","doi-asserted-by":"publisher","first-page":"13","DOI":"10.1111\/nyas.12012","article-title":"Cross\u2010reactive humoral responses to influenza and their implications for a universal vaccine","volume":"1283","author":"Chiu","year":"2013","journal-title":"Ann. N. Y. Acad. Sci."},{"key":"B7","doi-asserted-by":"publisher","first-page":"204","DOI":"10.1002\/jcla.21584","article-title":"Performance evaluation of LUMIPULSE G1200 autoimmunoanalyzer for the detection of serum hepatitis B virus markers","volume":"27","author":"Choi","year":"2013","journal-title":"J. Clin. Lab. Anal."},{"key":"B8","article-title":"Commission Implementing Regulation (EU) 2022\/1107 of 4 July 2022 laying down common specifications for certain class D in vitro diagnostic medical devices in accordance with Regulation (EU) 2017\/746 of the European Parliament and of the Council (Text with EEA relevance)","volume-title":"Official Journal of the European Union","year":"2022"},{"key":"B9","doi-asserted-by":"publisher","first-page":"843","DOI":"10.1007\/s11033-020-06056-4","article-title":"Dynamic profile of the HBeAg-anti-HBe system in acute and chronic hepatitis B virus infection: A clinical-laboratory approach: HBeAg and anti-HBe dynamics in the HBV infection","volume":"48","author":"de Almeida Pond\u00e9","year":"2021","journal-title":"Mol. Biol. Rep."},{"key":"B10","doi-asserted-by":"publisher","DOI":"10.3389\/fcimb.2025.1578060","article-title":"Evaluation of MAGLUMI syphilis test for accurate detection of syphilis antibodies in blood donors and suspected syphilis cases","volume":"15","author":"Fang","year":"2025","journal-title":"Front. Cell. Infect. Microbiol."},{"key":"B11","doi-asserted-by":"publisher","first-page":"121","DOI":"10.1111\/liv.12749","article-title":"HBV and the immune response","volume":"35","author":"Ferrari","year":"2015","journal-title":"Liver Int."},{"key":"B12","doi-asserted-by":"publisher","first-page":"524","DOI":"10.1038\/s41575-023-00760-9","article-title":"Global burden of hepatitis B virus: current status, missed opportunities and a call for action","volume":"20","author":"Hsu","year":"2023","journal-title":"Nat. Rev. Gastroenterol. Hepatol."},{"key":"B13","doi-asserted-by":"publisher","DOI":"10.7156\/V4I1P007","article-title":"Global epidemiology of hepatitis B virus (HBV) infection","volume":"4","author":"Hwang","year":"2011","journal-title":"North. Am. J. Med. Sci."},{"key":"B14","doi-asserted-by":"publisher","first-page":"19","DOI":"10.1038\/s41577-021-00549-4","article-title":"Immunobiology and pathogenesis of hepatitis B virus infection","volume":"22","author":"Iannacone","year":"2022","journal-title":"Nat. Rev. Immunol."},{"key":"B15","doi-asserted-by":"publisher","first-page":"553","DOI":"10.1586\/17474124.2.4.553","article-title":"Diagnosis of hepatitis B virus infection through serological and virological markers","volume":"2","author":"Kao","year":"2008","journal-title":"Expert Rev. Gastroenterol. Hepatol."},{"key":"B16","doi-asserted-by":"publisher","first-page":"1996","DOI":"10.1093\/clinchem\/40.11.1996","article-title":"Interference with clinical laboratory analyses","volume":"40","author":"Kroll","year":"1994","journal-title":"Clin. Chem."},{"key":"B17","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcv.2022.105219","article-title":"Comparative evaluation of four commercial analyzers for the serological screening of hepatitis A, B, C and HIV","volume":"153","author":"Kutvonen","year":"2022","journal-title":"J. Clin. Virol."},{"key":"B18","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1016\/s0009-8981(02)00275-9","article-title":"Towards a better understanding of heterophile (and the like) antibody interference with modern immunoassays","volume":"325","author":"Levinson","year":"2002","journal-title":"Clin. Chim. Acta"},{"key":"B19","doi-asserted-by":"publisher","DOI":"10.1016\/j.jviromet.2023.114770","article-title":"Clinical performance of the MAGLUMI Anti-HCV (CLIA) Test for detection of hepatitis C virus antibodies","volume":"319","author":"Li","year":"2023","journal-title":"J. Virological Methods"},{"key":"B20","doi-asserted-by":"publisher","first-page":"S13","DOI":"10.1002\/hep.22881","article-title":"Hepatitis B: the virus and disease","volume":"49","author":"Liang","year":"2009","journal-title":"Hepatology"},{"key":"B21","doi-asserted-by":"publisher","first-page":"306","DOI":"10.1016\/j.jcv.2012.12.022","article-title":"Quantification of hepatitis B e antigen between Elecsys HBeAg and Architect HBeAg assays among patients infected with hepatitis B virus","volume":"56","author":"Maylin","year":"2013","journal-title":"J. Clin. Virol."},{"key":"B22","doi-asserted-by":"publisher","first-page":"22","DOI":"10.1016\/j.jcv.2018.10.005","article-title":"Evaluation of performance characteristics of hepatitis B e antigen serologic assays","volume":"109","author":"Mixson-Hayden","year":"2018","journal-title":"J. Clin. Virol."},{"key":"B23","doi-asserted-by":"publisher","first-page":"176","DOI":"10.1016\/j.rgmxen.2021.11.007","article-title":"Comparative assessment of immunochromatography and ELISA diagnostic tests for HBsAg detection in PCR-confirmed HBV infection","volume":"87","author":"Navvabi","year":"2022","journal-title":"Rev. Gastroenterolog\u00eda M\u00e9xico (English Edition)"},{"key":"B24","doi-asserted-by":"publisher","first-page":"594","DOI":"10.1016\/j.jhep.2009.10.033","article-title":"Mechanisms of HBV-related hepatocarcinogenesis","volume":"52","author":"Neuveut","year":"2010","journal-title":"J. Hepatol."},{"key":"B25","doi-asserted-by":"publisher","DOI":"10.62019\/kb0wvc28","article-title":"Comparative analysis of molecular and chemiluminescent assays for HBeAg and anti-HBe antibodies quantification in chronic hepatitis B patients","volume":"2","author":"Numan","year":"2025","journal-title":"J. Med. Health Sci. Rev."},{"key":"B26","doi-asserted-by":"publisher","first-page":"101","DOI":"10.1016\/j.chroma.2011.10.050","article-title":"Is it really necessary to validate an analytical method or not? That is the question","volume":"1232","author":"Rambla-Alegre","year":"2012","journal-title":"J. Chromatogr. A"},{"key":"B27","doi-asserted-by":"publisher","first-page":"91","DOI":"10.7326\/0003-4819-126-1-199701010-00026","article-title":"Sensitivity\u201d and \u201cspecificity\u201d reconsidered: the meaning of these terms in analytical and diagnostic settings","volume":"126","author":"Saah","year":"1997","journal-title":"Am. Coll. Physicians"},{"key":"B28","doi-asserted-by":"publisher","DOI":"10.1002\/jmv.29817","article-title":"Performance evaluation of the MAGLUMI Hepatitis B virus surface antigen chemiluminescence immunoassay","volume":"96","author":"Shen","year":"2024","journal-title":"J. Med. Virol."},{"key":"B29","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0331381","article-title":"Comparative evaluation of four fully automated immunoanalyzers for the simultaneous detection of HBeAg and Anti-HBe","volume":"20","author":"Song","year":"2025","journal-title":"PloS One"},{"key":"B30","doi-asserted-by":"publisher","first-page":"771","DOI":"10.1056\/NEJM197504102921503","article-title":"Vertical transmission of hepatitis B antigen in Taiwan","volume":"292","author":"Stevens","year":"1975","journal-title":"N. Engl. J. Med."},{"key":"B31","first-page":"105","article-title":"Interferences in immunoassay","volume":"25","author":"Tate","year":"2004","journal-title":"Clin. Biochemist Rev."},{"key":"B32","doi-asserted-by":"publisher","first-page":"37","DOI":"10.1080\/22221751.2020.1862631","article-title":"Specific determination of hepatitis B e antigen by antibodies targeting precore unique epitope facilitates clinical diagnosis and drug evaluation against hepatitis B virus infection","volume":"10","author":"Wang","year":"2021","journal-title":"Emerging Microbes Infections"},{"key":"B33","doi-asserted-by":"publisher","DOI":"10.1002\/jcla.22015","article-title":"The performance of the Abbott i2000 for measuring serum markers of infectious diseases","volume":"31","author":"Wang","year":"2017","journal-title":"J. Clin. Lab. Anal."},{"key":"B34","doi-asserted-by":"publisher","first-page":"290","DOI":"10.1186\/s12985-024-02565-x","article-title":"Evaluation of the MAGLUMI HIV Ab\/Ag combi test for the detection of HIV infection","volume":"21","author":"Wang","year":"2024","journal-title":"Virol. J."},{"key":"B35","doi-asserted-by":"publisher","first-page":"100527","DOI":"10.1016\/j.clinme.2025.100527","article-title":"Chronic hepatitis B in 2025: diagnosis, treatment and future directions","volume":"25","author":"Watson","year":"2025","journal-title":"Clin. Med."}],"container-title":["Frontiers in Cellular and Infection Microbiology"],"original-title":[],"link":[{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fcimb.2026.1867239\/full","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,8,19]],"date-time":"2026-08-19T04:38:31Z","timestamp":1787114311000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fcimb.2026.1867239\/full"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,8,19]]},"references-count":35,"alternative-id":["10.3389\/fcimb.2026.1867239"],"URL":"https:\/\/doi.org\/10.3389\/fcimb.2026.1867239","relation":{},"ISSN":["2235-2988"],"issn-type":[{"value":"2235-2988","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,8,19]]},"article-number":"1867239"}}