{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,19]],"date-time":"2026-08-19T04:24:49Z","timestamp":1787113489426,"version":"build-2736575974"},"reference-count":13,"publisher":"SAGE Publications","license":[{"start":{"date-parts":[[2026,8,1]],"date-time":"2026-08-01T00:00:00Z","timestamp":1785542400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2026,8,1]],"date-time":"2026-08-01T00:00:00Z","timestamp":1785542400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Tumour Biol."],"published-print":{"date-parts":[[2026,8]]},"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Serum tumor markers such as carcinoembryonic antigen (CEA), alpha-fetoprotein (AFP), and prostate-specific antigen (PSA) are crucial to clinical decision-making based on defined medical thresholds. However, significant inter-method variability and lack of harmonization limit result comparability and hinder consistent application of international guidelines.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>This letter proposes an expanded role for External Quality Assessment (EQA) programs as active drivers of assay harmonization beyond conventional proficiency testing.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>This proposal draws on recent studies evaluating the commutability of frozen human serum pools (FSPs) from the Korean Association of External Quality Assessment Service (KEQAS) and findings from EQA-based harmonization simulations. It demonstrated that harmonization of tumor markers such as CA 15-3 and CEA, is achievable.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>KEQAS FSPs demonstrated commutability for AFP, CEA, and total PSA across major diagnostic platforms. Simulation results indicated that \u201cin silico\u201d recalibration substantially reduced inter-method variability; for example, the bias range for CA 15-3 was reduced from [\u221229.28%, 9.86%] to [\u22120.09%, 0.12%], and recalibrating outlier methods for CEA improved the alignment also.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>EQA programs can serve as practical harmonization hubs by leveraging commutable materials and implementing EQA-driven recalibration. Such approaches can help that medical decision points, retain consistent clinical significance across diverse analytical systems.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/14230380261472771","type":"journal-article","created":{"date-parts":[[2026,8,17]],"date-time":"2026-08-17T03:59:45Z","timestamp":1786939185000},"update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":0,"title":["Beyond proficiency testing: Leveraging commutable External Quality Assessment data to harmonize tumor markers and refine medical decision points"],"prefix":"10.1177","volume":"48","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7449-7978","authenticated-orcid":false,"given":"Jong Do","family":"Seo","sequence":"first","affiliation":[{"name":"Konkuk University Medical Center"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5757-9779","authenticated-orcid":false,"given":"Huub H.","family":"Van Rossum","sequence":"additional","affiliation":[{"name":"Netherlands Cancer Institute"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5485-8331","authenticated-orcid":false,"given":"Yeo-Min","family":"Yun","sequence":"additional","affiliation":[{"name":"Konkuk University Medical Center"},{"name":"Konkuk University School of Medicine"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2026,8,16]]},"reference":[{"key":"e_1_3_4_2_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.annonc.2020.06.011"},{"key":"e_1_3_4_3_2","doi-asserted-by":"publisher","DOI":"10.6004\/jnccn.2021.0012"},{"key":"e_1_3_4_4_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.annonc.2022.10.003"},{"key":"e_1_3_4_5_2","doi-asserted-by":"publisher","DOI":"10.3343\/alm.2018.38.4.355"},{"key":"e_1_3_4_6_2","first-page":"594","article-title":"Standardization of tumor markers-priorities identified through external quality assessment","volume":"245","author":"Sturgeon C","year":"2016","unstructured":"Sturgeon C. Standardization of tumor markers-priorities identified through external quality assessment. Scand J Clin Lab Invest Suppl 2016; 245: 594\u2013599. https:\/\/doi.org\/10.1080\/00365513.2016.1210334","journal-title":"Scand J Clin Lab Invest Suppl"},{"key":"e_1_3_4_7_2","doi-asserted-by":"publisher","DOI":"10.1093\/clinchem\/hvae005"},{"key":"e_1_3_4_8_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.annonc.2023.08.009"},{"key":"e_1_3_4_9_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.pan.2017.11.011"},{"key":"e_1_3_4_10_2","unstructured":"Cardiff (UK). National collaborating centre for cancer (UK); 2011 apr. National Institute for health and care excellence: guidelines. Ovarian cancer: the recognition and initial management of ovarian cancer. Available from: https:\/\/www.nice.org.uk\/guidance\/cg122"},{"key":"e_1_3_4_11_2","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2015.61.1459"},{"key":"e_1_3_4_12_2","article-title":"External quality assessment-based tumor marker harmonization simulation; insights in achievable harmonization for CA 15-3 and CEA","author":"Van Rossum HH","year":"2024","unstructured":"Van Rossum HH, Holdenrieder S, Yun YM, et al. External quality assessment-based tumor marker harmonization simulation; insights in achievable harmonization for CA 15-3 and CEA. Clin Chem Lab Med 2024. https:\/\/doi.org\/10.1515\/cclm-2024-0696, [Epub ahead of print].","journal-title":"Clin Chem Lab Med"},{"key":"e_1_3_4_13_2","doi-asserted-by":"publisher","DOI":"10.1373\/clinchem.2017.277525"},{"key":"e_1_3_4_14_2","doi-asserted-by":"publisher","DOI":"10.15263\/jlmqa.2022.44.2.111"}],"container-title":["Tumor Biology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/14230380261472771","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/14230380261472771","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/14230380261472771","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,8,19]],"date-time":"2026-08-19T03:46:23Z","timestamp":1787111183000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1177\/14230380261472771"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,8]]},"references-count":13,"alternative-id":["10.1177\/14230380261472771"],"URL":"https:\/\/doi.org\/10.1177\/14230380261472771","relation":{},"ISSN":["1010-4283","1423-0380"],"issn-type":[{"value":"1010-4283","type":"print"},{"value":"1423-0380","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,8]]},"article-number":"14230380261472771"}}