{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,26]],"date-time":"2026-10-26T10:36:37Z","timestamp":1793010997393,"version":"4.5.0"},"reference-count":17,"publisher":"Wiley","issue":"10","license":[{"start":{"date-parts":[[2026,9,24]],"date-time":"2026-09-24T00:00:00Z","timestamp":1790208000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2026,9,24]],"date-time":"2026-09-24T00:00:00Z","timestamp":1790208000000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Int J of Rheum Dis"],"published-print":{"date-parts":[[2026,10]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Aim<\/jats:title>\n                    <jats:p>MPO\u2010ANCA detection suffers prominent inter\u2010assay variability due to a shortage of standardized, sustainable quality control (QC) materials. Existing patient\u2010pooled sera have limited supply, while chimeric monoclonal antibodies fail to fully mimic human autoantibodies. This study aimed to construct a fully human recombinant MPO\u2010ANCA monoclonal antibody and systematically characterize its analytical performance as a candidate QC material for multi\u2010platform MPO\u2010ANCA immunoassay evaluation.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>A human anti\u2010MPO scFv phage display library was constructed using peripheral blood mononuclear cells obtained from MPO\u2010ANCA\u2010positive patients. Following antigen\u2010specific biopanning and screening, the candidate clone H042 was selected and converted into a full\u2010length human IgG1 monoclonal antibody. We verified its structural integrity, antigen specificity, pANCA immunofluorescence pattern, quantitative linearity, thermal\/freeze\u2013thaw stability, and cross\u2010kit performance across enzyme\u2010linked immunosorbent assay (ELISA), chemiluminescence immunoassay (CLIA), multiplex flow immunoassay, and indirect immunofluorescence assay (IIFA) from multiple mainstream manufacturers.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Purified H042 exhibited intact IgG structure, strong MPO binding affinity, and no cross\u2010reactivity with PR3\/GBM. It presented typical pANCA staining in IIFA and showed predictable quantitative response. H042 retained &gt;\u200989% residual activity under accelerated thermal and repeated freeze\u2013thaw stress. Notably, H042 yielded consistent qualitative positivity on all tested kits of four mainstream methodologies without false\u2010negative signals, despite inter\u2010platform signal intensity differences.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>The fully human monoclonal antibody H042 demonstrated favorable structural integrity, MPO specificity, and broad detectability across the evaluated commercial assay platforms. These characteristics support its potential as a scalable recombinant candidate QC material and an auxiliary tool for MPO\u2010ANCA assay harmonization and laboratory quality assurance.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/1756-185x.70889","type":"journal-article","created":{"date-parts":[[2026,9,25]],"date-time":"2026-09-25T04:56:45Z","timestamp":1790312205000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Development and Characterization of a Fully Human Recombinant\n                    <scp>MPO<\/scp>\n                    \u2010\n                    <scp>ANCA<\/scp>\n                    Monoclonal Antibody as Candidate Quality Control Material"],"prefix":"10.1111","volume":"29","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-5014-3347","authenticated-orcid":false,"given":"Meiyu","family":"Guo","sequence":"first","affiliation":[{"name":"Department of Rheumatology Beijing Hospital, National Center for Gerontology, National Clinical Research Center for Gerontology, The Key Laboratory of Geriatrics of NHC, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences &amp; Peking Union Medical College  Beijing P.R. China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2959-0759","authenticated-orcid":false,"given":"Yeshuang","family":"Yuan","sequence":"additional","affiliation":[{"name":"National Center for Clinical Laboratories, Beijing Hospital, National Center for Gerontology, National Clinical Research Center for Gerontology, The Key Laboratory of Geriatrics of NHC, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences  Beijing P.R. China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8775-1699","authenticated-orcid":false,"given":"Xuan","family":"Zhang","sequence":"additional","affiliation":[{"name":"Department of Rheumatology Beijing Hospital, National Center for Gerontology, National Clinical Research Center for Gerontology, The Key Laboratory of Geriatrics of NHC, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences &amp; Peking Union Medical College  Beijing P.R. China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5153-3400","authenticated-orcid":false,"given":"Yudong","family":"Liu","sequence":"additional","affiliation":[{"name":"National Center for Clinical Laboratories, Beijing Hospital, National Center for Gerontology, National Clinical Research Center for Gerontology, The Key Laboratory of Geriatrics of NHC, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences  Beijing P.R. China"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,9,24]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.41986"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2021-221796"},{"key":"e_1_2_9_4_1","first-page":"887","article-title":"First\u2010Year Cumulative Myeloperoxidase\u2010ANCA Titres Are Associated With All\u2010Cause Mortality in Patients With Microscopic Polyangiitis","volume":"42","author":"Rah W.","year":"2024","journal-title":"Clinical and Experimental Rheumatology"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.3389\/fimmu.2025.1649708"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2018-214078"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.1111\/cei.12707"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.1515\/cclm-2023-0764"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2016-209507"},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cca.2016.05.031"},{"key":"e_1_2_9_11_1","doi-asserted-by":"publisher","DOI":"10.1136\/annrheumdis-2020-217416"},{"key":"e_1_2_9_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jim.2026.114051"},{"key":"e_1_2_9_13_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpz1.182"},{"key":"e_1_2_9_14_1","doi-asserted-by":"publisher","DOI":"10.1007\/978-1-4939-7447-4_17"},{"key":"e_1_2_9_15_1","doi-asserted-by":"publisher","DOI":"10.3389\/fimmu.2021.656796"},{"key":"e_1_2_9_16_1","doi-asserted-by":"publisher","DOI":"10.1080\/25785826.2024.2408054"},{"key":"e_1_2_9_17_1","doi-asserted-by":"publisher","DOI":"10.31138\/mjr.30.1.26"},{"key":"e_1_2_9_18_1","doi-asserted-by":"publisher","DOI":"10.1038\/nrrheum.2013.180"}],"container-title":["International Journal of Rheumatic Diseases"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/1756-185x.70889","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/1756-185x.70889","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/1756-185x.70889","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,10,26]],"date-time":"2026-10-26T10:25:32Z","timestamp":1793010332000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/1756-185x.70889"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,9,24]]},"references-count":17,"journal-issue":{"issue":"10","published-print":{"date-parts":[[2026,10]]}},"alternative-id":["10.1111\/1756-185x.70889"],"URL":"https:\/\/doi.org\/10.1111\/1756-185x.70889","archive":["Portico"],"relation":{},"ISSN":["1756-1841","1756-185X"],"issn-type":[{"value":"1756-1841","type":"print"},{"value":"1756-185X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,9,24]]},"assertion":[{"value":"2026-07-15","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-09-16","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-09-24","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e70889"}}