{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,27]],"date-time":"2026-08-27T19:21:11Z","timestamp":1787858471788,"version":"build-2784847793"},"reference-count":27,"publisher":"Walter de Gruyter GmbH","issue":"10","license":[{"start":{"date-parts":[[2026,6,8]],"date-time":"2026-06-08T00:00:00Z","timestamp":1780876800000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2026,9,25]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec id=\"j_cclm-2026-0044_abs_001\">\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>\n                      Use of polyclonal antibodies (pAbs) in immunoassays has limitations related to inter-batch variation and supply chain stability which may affect assay reproducibility, scalability, and sustainability. The Elecsys\n                      <jats:sup>\u00ae<\/jats:sup>\n                      Anti-TPO II assay, where the pAb of the Elecsys Anti-TPO assay has been replaced with two monoclonal antibodies, aims to address these factors. We evaluated analytical and clinical performance for Elecsys Anti-TPO II using Cobas\n                      <jats:sup>\u00ae<\/jats:sup>\n                      e 601 and e 801 analyzers.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"j_cclm-2026-0044_abs_002\">\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Repeatability, intermediate precision, and reproducibility were assessed over 5 days at three sites, within\/between multiple reagent lots and analyzers. Method comparisons were performed against Elecsys Anti-TPO and three other immunoassays, using 218 serum samples covering the measuring range. The clinical cutoff was derived from 85 patients with confirmed Hashimoto thyroiditis (HT); reference intervals determined using samples from 230 healthy euthyroid individuals. Clinical performance was evaluated in 608 patients with confirmed HT, Graves disease, non-autoimmune thyroid diseases, or non-thyroid autoimmune diseases.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"j_cclm-2026-0044_abs_003\">\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Elecsys Anti-TPO II demonstrated high precision (standard deviations for repeatability, intermediate precision, and reproducibility &lt;1.6\u202fIU\/mL for measurements \u226430\u202fIU\/mL; coefficients of variation &lt;7\u202f% for measurements &gt;30\u202fIU\/mL) and improved semi-quantitative agreement (94.0\u201397.7\u202f%) with comparator assays, vs. Elecsys Anti-TPO (88.5\u201390.8\u202f%). The 95th percentile of the reference range cohort was &lt;8\u202fIU\/mL; specificity in this cohort was 97.4\u202f% (cutoff of \u226520\u202fIU\/mL). Clinical sensitivity for HT was 90.5\u202f%; clinical specificity in disease control groups was 90.7\u202f%.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"j_cclm-2026-0044_abs_004\">\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Elecsys Anti-TPO II offers robust analytical and clinical performance, supporting its utility in diagnosing auto-immune thyroid diseases in routine clinical practice.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1515\/cclm-2026-0044","type":"journal-article","created":{"date-parts":[[2026,6,9]],"date-time":"2026-06-09T02:43:13Z","timestamp":1780972993000},"page":"2297-2306","source":"Crossref","is-referenced-by-count":0,"title":["Analytical and clinical performance of the updated Elecsys Anti-TPO II assay for the detection of antibodies against thyroid peroxidase to aid in the diagnosis of autoimmune thyroid diseases"],"prefix":"10.1515","volume":"64","author":[{"given":"Kenneth D.","family":"Burman","sequence":"first","affiliation":[{"name":"Endocrine Section, Medstar Washington Hospital Center , Washington , DC , USA"},{"name":"Department of Medicine , Georgetown University , Washington , DC , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8132-1986","authenticated-orcid":false,"given":"Lowell R.","family":"Schmeltz","sequence":"additional","affiliation":[{"name":"Associated Endocrinologists \/ Michigan Healthcare Professionals, Oakland University William Beaumont School of Medicine , Rochester , MI , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yoko","family":"Momoyama","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine , Duly Health and Care , Lombard , IL , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7677-6556","authenticated-orcid":false,"given":"Feyza","family":"Erenler","sequence":"additional","affiliation":[{"name":"Division of Endocrinology, Diabetes and Metabolism , Tufts Medical Center , Boston , MA , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Samer","family":"Nakhle","sequence":"additional","affiliation":[{"name":"Palm Research Center Inc. , Las Vegas , NV , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3901-5771","authenticated-orcid":false,"given":"Fabian A.","family":"Mendoza-Ballesteros","sequence":"additional","affiliation":[{"name":"Department of Medicine , Thomas Jefferson University , Philadelphia , PA , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Arvind","family":"Krishna","sequence":"additional","affiliation":[{"name":"Diabetes and Endocrinology Associates of Stark County Inc. , Canton , OH , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Meera","family":"Amar","sequence":"additional","affiliation":[{"name":"Diabetes & Endocrine Research Center , Waco , TX , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David G.","family":"Robertson","sequence":"additional","affiliation":[{"name":"Atlanta Diabetes Associates PC , Atlanta , GA , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9746-7138","authenticated-orcid":false,"given":"Catherine","family":"Anastasopoulou","sequence":"additional","affiliation":[{"name":"Jefferson Einstein Medical Center, Einstein Endocrinology Associates , Montgomery , PA , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8218-2789","authenticated-orcid":false,"given":"Mark A.","family":"Lupo","sequence":"additional","affiliation":[{"name":"Thyroid & Endocrine Center of Florida , Sarasota , FL , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael H.","family":"Shanik","sequence":"additional","affiliation":[{"name":"Endocrine Associates of Long Island PC , Smithtown , NY , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John Y.","family":"Jun","sequence":"additional","affiliation":[{"name":"Division of Endocrinology, Diabetes and Metabolism, Department of Medicine , University of Toledo College of Medicine and Life Sciences , Toledo , OH , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0003-0827-4903","authenticated-orcid":false,"given":"Trisha D.","family":"Cubb","sequence":"additional","affiliation":[{"name":"The Methodist Hospital Research Institute d\/b\/a Houston Methodist Research Institute , Houston , TX , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0009-9699-1948","authenticated-orcid":false,"given":"Olga","family":"Senashova","sequence":"additional","affiliation":[{"name":"Oregon Health & Science University , Portland , OR , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4970-6536","authenticated-orcid":false,"given":"Andrew J.","family":"Behnke","sequence":"additional","affiliation":[{"name":"Section of Endocrinology, Carilion Clinic \/ Virginia Tech School of Medicine , Roanoke , VA , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Brodbeck","sequence":"additional","affiliation":[{"name":"TRIGA-S GmbH Scientific Solutions , Habach , Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sandra","family":"Yasavul","sequence":"additional","affiliation":[{"name":"Clinical Study Management, Roche Diagnostics GmbH , Penzberg , Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter","family":"Dilba","sequence":"additional","affiliation":[{"name":"Clinical Biostatistics , Roche Diagnostics GmbH , Penzberg , Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Oliver","family":"Lorenz","sequence":"additional","affiliation":[{"name":"Assay Development, Roche Diagnostics GmbH , Penzberg , Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0000-3072-7209","authenticated-orcid":false,"given":"Johanna","family":"Sillman","sequence":"additional","affiliation":[{"name":"Clinical Development, Roche Diagnostics Int. AG , Rotkreuz , Switzerland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter","family":"Findeisen","sequence":"additional","affiliation":[{"name":"MVZ Labor Dr. Limbach & Kollegen eGbr. , Heidelberg , Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"374","published-online":{"date-parts":[[2026,6,8]]},"reference":[{"key":"2026082719044860574_j_cclm-2026-0044_ref_001","doi-asserted-by":"crossref","unstructured":"Fr\u00f6hlich, E, Wahl, R. Thyroid autoimmunity: role of anti-thyroid antibodies in thyroid and extra-thyroidal diseases. Front Immunol 2017;8:521. https:\/\/doi.org\/10.3389\/fimmu.2017.00521.","DOI":"10.3389\/fimmu.2017.00521"},{"key":"2026082719044860574_j_cclm-2026-0044_ref_002","doi-asserted-by":"crossref","unstructured":"Ruf, J, Carayon, P. Structural and functional aspects of thyroid peroxidase. 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Chapter 11: thyroid physiology and diagnostic evaluation of patients with thyroid disorders. In: Melmed, S, Polonsky, KSPRL, Kronenberg, HM, editors. Williams textbook of endocrinology, 13th ed. Philadelphia: Elsevier; 2016:333\u201368 pp.","DOI":"10.1016\/B978-0-323-29738-7.00011-3"},{"key":"2026082719044860574_j_cclm-2026-0044_ref_008","unstructured":"Roche Diagnostics GmbH. Elecsys\u00ae Anti-TPO: product specification; 2025. https:\/\/elabdoc-prod.roche.com\/eLD\/web\/global\/en\/products\/CPS_000444 [Accessed 29 July 2025]."},{"key":"2026082719044860574_j_cclm-2026-0044_ref_009","doi-asserted-by":"crossref","unstructured":"D\u00fcbel, S. Can antibodies be \u201cvegan\u201d? A guide through the maze of today\u2019s antibody generation methods. MAbs 2024;16:2343499. https:\/\/doi.org\/10.1080\/19420862.2024.2343499.","DOI":"10.1080\/19420862.2024.2343499"},{"key":"2026082719044860574_j_cclm-2026-0044_ref_010","unstructured":"Roche Diagnostics GmbH. 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