{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,29]],"date-time":"2026-08-29T03:18:44Z","timestamp":1787973524476,"version":"build-2784847793"},"reference-count":22,"publisher":"Wiley","license":[{"start":{"date-parts":[[2026,8,28]],"date-time":"2026-08-28T00:00:00Z","timestamp":1787875200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2026,8,28]],"date-time":"2026-08-28T00:00:00Z","timestamp":1787875200000},"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":["Cytometry Part B Clinical"],"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>In ISO 15189\u2010accredited medical laboratories, estimation and management of measurement uncertainty (MU) is a fundamental requirement. However, both the theoretical and practical aspects of MU estimation in medical testing are still evolving. In the specific context of clinical flow cytometry, only a limited number of publications address this subject. A survey distributed to European Society of Clinical Cell Analysis members revealed that guidance in this area would be valuable, as current practices vary significantly across laboratories and countries. To address this, a dedicated working group was established to explore how MU could be implemented in flow cytometry laboratories in a manner that embeds it in the laboratory's quality system and that is consistent with ISO 15189:2022 requirements, with the view to avoid it becoming a mere compliance task. Given that a significant number of flow cytometry assays yield qualitative rather than quantitative results and considering the patient\u2010focused, risk\u2010based perspective of the 15189:2022 standards, we approached MU from the perspective of understanding process variability. This paper details and summarizes the result of our work. We present a set of recommendations aimed to help flow cytometry laboratories approach this subject effectively; providing guidance for the types of assays that may be suited for an estimated and monitored MU, and recommendations for how to adopt a structured, risk\u2010based methodology to minimize sources of variation for all assays. This involves identifying sources of uncertainty throughout the analytical process, evaluating their impact, and prioritizing control efforts where the risk to result integrity and patient safety is greatest.<\/jats:p>","DOI":"10.1002\/cyto.b.70064","type":"journal-article","created":{"date-parts":[[2026,8,29]],"date-time":"2026-08-29T03:06:31Z","timestamp":1787972791000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["<scp>ESCCA<\/scp>\n                    recommendations for managing measurement uncertainty in\n                    <scp>ISO<\/scp>\n                    15189 accredited flow cytometry laboratories: A risk\u2010based approach"],"prefix":"10.1002","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0743-7400","authenticated-orcid":false,"given":"Ulrika","family":"Johansson","sequence":"first","affiliation":[{"name":"SI\u2010HMDS University Hospitals Bristol and Weston NHS Foundation Trust  Bristol UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0353-0421","authenticated-orcid":false,"given":"Catarina","family":"Martins","sequence":"additional","affiliation":[{"name":"Comprehensive Health Research Centre, NOVA Medical School, Faculdade de Ci\u00eancias M\u00e9dicas Universidade NOVA de Lisboa  Lisbon Portugal"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Neil","family":"McIver\u2010Brown","sequence":"additional","affiliation":[{"name":"SI\u2010HMDS University Hospitals Dorset NHS Foundation Trust  Bournemouth UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eleni","family":"Linskens","sequence":"additional","affiliation":[{"name":"Department of Clinical Biology, Laboratory Hematology University Hospital Brussels  Brussels Belgium"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2724-2299","authenticated-orcid":false,"given":"Efthalia","family":"Yiannaki","sequence":"additional","affiliation":[{"name":"Laboratory of Haematology Cancer Hospital of Theageneio  Thessaloniki Greece"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas","family":"Keller","sequence":"additional","affiliation":[{"name":"ACOMED Statistik  Leipzig Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Bloxham","sequence":"additional","affiliation":[{"name":"HODS Cambridge University Hospitals NHS Foundation Trust  Cambridge UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francesco","family":"Buccisano","sequence":"additional","affiliation":[{"name":"Ematologia, Dipartimento di Biomedicina e Prevenzione \u201cTor Vergata\u201d Universit\u00e0 di Roma  Rome Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kathryn","family":"Clarke","sequence":"additional","affiliation":[{"name":"Department of Haematology Belfast City Hospital  Belfast Northern Ireland UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria Jo\u00e3o","family":"Acosta","sequence":"additional","affiliation":[{"name":"Clinical Pathology Department, Flow Cytometry Laboratory Hospital de S\u00e3o Francisco Xavier, Centro Hospitalar de Lisboa Ocidental  Lisbon Portugal"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Katy","family":"Jones","sequence":"additional","affiliation":[{"name":"SE\u2010HMDS King's College Hospital, Synnovis  London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6452-2874","authenticated-orcid":false,"given":"Wolfgang","family":"Kern","sequence":"additional","affiliation":[{"name":"MLL Munich Leukemia Laboratory  Munich Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Juan","family":"Flores\u2010Montero","sequence":"additional","affiliation":[{"name":"Centro de Investigacion Biomedica en Red de Cancer Institudo de Salud Carlos III  Madrid Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel","family":"Payne","sequence":"additional","affiliation":[{"name":"Immunology, Tees Valley Pathology James Cook University Hospital  Middlesbrough UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2182-7536","authenticated-orcid":false,"given":"Katherina","family":"Psarra","sequence":"additional","affiliation":[{"name":"Department of Immunology and Histocompatibility \u201cEvangelismos\u201d General Hospital  Athens Greece"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ulrich","family":"Sack","sequence":"additional","affiliation":[{"name":"Medical Faculty, Institute of Clinical Immunology University of Leipzig  Leipzig Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Richard","family":"Veyrat\u2010Masson","sequence":"additional","affiliation":[{"name":"H\u00e9matologie Biologique Centre Hospitalier Universitaire, H\u00f4spital Estaing  Clermont Ferrand France"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,8,28]]},"reference":[{"key":"e_1_2_7_2_1","volume-title":"A beginner's guide to uncertainty of measurement","author":"Bell S. 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T.","year":"2022","journal-title":"Cytometry Part B: Clinical Cytometry"},{"key":"e_1_2_7_9_1","volume-title":"Medical laboratories\u2014Practical guidance for the estimation of measurement uncertainty ISO\/TS\u201020914","author":"International Organization of Standardization (ISO)","year":"2019"},{"key":"e_1_2_7_10_1","volume-title":"Medical laboratories\u2014Requirements for quality and competence. 15189:2022","author":"International Organization of Standardization (ISO)","year":"2022"},{"key":"e_1_2_7_11_1","volume-title":"100: 2008 (GUM 1995 with minor corrections) Evaluation of measurement data \u2013 Guide to the expression of uncertainty in measurement","author":"Joint Committee for Guides in Metrology (JCGM)","year":"2008"},{"key":"e_1_2_7_12_1","doi-asserted-by":"crossref","DOI":"10.3389\/fimmu.2020.02169","article-title":"Flow cytometric analyses of lymphocyte markers in immune oncology: A comprehensive guidance for validation practice according to laws and standards","volume":"11","author":"Lambert C.","year":"2020","journal-title":"Frontiers in Immunology"},{"key":"e_1_2_7_13_1","first-page":"1025","article-title":"Comparison between bottom\u2010up and top\u2010down approaches in the estimation of measurement uncertainty","volume":"53","author":"Lee J. 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