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The standardisation of these immunoassays is of critical importance, where inter-method variability and a lack of harmonisation can impact the comparability of results and affect clinical utility. World Health Organisation (WHO) International Standards (IS) are available for many of these protein tumour markers.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>To provide an overview of how these WHO IS are prepared, characterised and established, and introduce the IS that are available for the calibration of tumour marker immunoassays.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results and conclusion<\/jats:title>\n                    <jats:p>Although WHO IS are available for many protein tumour markers, there remains a need for improvement in the harmonisation of some of these assays to enable more widespread and optimum utilisation in clinical practice. It will remain important to maintain these WHO International Standards, to achieve harmonisation through consistent global calibration of these assays, in addition to supporting the development of new technologies as they arise.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/14230380261493875","type":"journal-article","created":{"date-parts":[[2026,10,15]],"date-time":"2026-10-15T21:48:11Z","timestamp":1792100891000},"update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":0,"title":["WHO International Standards for tumour markers: Development, characterisation and future perspectives"],"prefix":"10.1177","volume":"48","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9676-6868","authenticated-orcid":false,"given":"Melanie","family":"Moore","sequence":"first","affiliation":[{"name":"Medicines and Healthcare products Regulatory Agency"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6952-0376","authenticated-orcid":false,"given":"Katherine","family":"Partridge","sequence":"additional","affiliation":[{"name":"Medicines and Healthcare products Regulatory Agency"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0002-8219-1252","authenticated-orcid":false,"given":"Dina","family":"Vara","sequence":"additional","affiliation":[{"name":"Medicines and Healthcare products Regulatory Agency"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6013-6263","authenticated-orcid":false,"given":"Leandro","family":"Lo Cascio","sequence":"additional","affiliation":[{"name":"Medicines and Healthcare products Regulatory Agency"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ben","family":"Cowper","sequence":"additional","affiliation":[{"name":"Medicines and Healthcare products Regulatory Agency"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2026,10,15]]},"reference":[{"key":"e_1_3_4_2_2","doi-asserted-by":"publisher","DOI":"10.1515\/cclm-2022-1090"},{"key":"e_1_3_4_3_2","doi-asserted-by":"publisher","DOI":"10.1159\/000338393"},{"key":"e_1_3_4_4_2","doi-asserted-by":"publisher","DOI":"10.1080\/00365513.2016.1210334"},{"key":"e_1_3_4_5_2","doi-asserted-by":"publisher","DOI":"10.1093\/clinchem\/hvae005"},{"issue":"1","key":"e_1_3_4_6_2","first-page":"225","article-title":"The importance of World Health Organization international reference standards in the product life cycle of biosimilars","volume":"1540","author":"Kang H-N","year":"2024","unstructured":"Kang H-N, Wadhwa M, Knezevic I, et al. 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