{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,17]],"date-time":"2026-04-17T22:24:21Z","timestamp":1776464661926,"version":"3.51.2"},"reference-count":30,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2020,10,28]],"date-time":"2020-10-28T00:00:00Z","timestamp":1603843200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Cytometry Part B Clinical"],"published-print":{"date-parts":[[2021,3]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Introducing a sensitive and specific peripheral blood flow cytometric assay for S\u00e9zary syndrome and mycosis fungoides (SS\/MF) requires careful selection of assay design characteristics, and translation into a laboratory developed assay through development\/optimization, validation, and continual quality monitoring. As outlined in a previous article in this series, the recommended design characteristics of this assay include at a minimum, evaluation of CD7, CD3, CD4, CD8, CD26, and CD45, analyzed simultaneously, requiring at least a 6 color flow cytometry system, with both quantitative and qualitative components. This article provides guidance from an international group of cytometry specialists in implementing an assay to those design specifications, outlining specific considerations, and best practices. Key points presented in detail are: (a) Pre\u2010analytic components (reagents, specimen processing, and acquisition) must be optimized to: (i) identify and characterize an abnormal population of T\u2010cells (qualitative component) and (ii) quantitate the abnormal population (semi\/quasi\u2010quantitative component). (b)Analytic components (instrument set\u2010up\/acquisition\/analysis strategy and interpretation) must be optimized for the identification of SS\/MF populations, which can vary widely in phenotype. Comparison with expert laboratories is strongly encouraged in order to establish competency. (c) Assay performance must be validated and documented through a validation plan and report, which covers both qualitative and semi\/quasi\u2010quantitative assay components (example template provided). (d) Ongoing assay\u2010specific quality monitoring should be performed to ensure consistency.<\/jats:p>","DOI":"10.1002\/cyto.b.21963","type":"journal-article","created":{"date-parts":[[2020,10,28]],"date-time":"2020-10-28T12:59:04Z","timestamp":1603889944000},"page":"156-182","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":13,"title":["International guidelines for the flow cytometric evaluation of peripheral blood for suspected S\u00e9zary syndrome or mycosis fungoides: Assay development\/optimization, validation, and ongoing quality monitors"],"prefix":"10.1002","volume":"100","author":[{"given":"Andrea","family":"Illingworth","sequence":"first","affiliation":[{"name":"Flow Cytometry Division Dahl\u2010Chase Diagnostic Services  Bangor Maine USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ulrika","family":"Johansson","sequence":"additional","affiliation":[{"name":"SI\u2010HMDS University Hospitals Bristol and Weston NHS Foundation Trust  Bristol UK"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shuguang","family":"Huang","sequence":"additional","affiliation":[{"name":"Stat4ward LLC  Pittsburgh Pennsylvania USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Pedro","family":"Horna","sequence":"additional","affiliation":[{"name":"Division of Hematopathology Mayo Clinic  Rochester Minnesota USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sa A.","family":"Wang","sequence":"additional","affiliation":[{"name":"Department of Hematopathology MD Anderson Cancer Center  Houston Texas USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Julia","family":"Almeida","sequence":"additional","affiliation":[{"name":"Cancer Research Center (IBMCC\u2010CSIC\/USAL\u2010IBSAL); Cytometry Service (NUCLEUS) and Department of Medicine, IBSAL and CIBERONC University of Salamanca  Salamanca Spain"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kristy L.","family":"Wolniak","sequence":"additional","affiliation":[{"name":"Division of Hematopathology, Department of Pathology Northwestern University Feinberg School of Medicine  Chicago Illinois USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Katherina","family":"Psarra","sequence":"additional","affiliation":[{"name":"Department of Immunology \u2013 Histocompatibility \"Evangelismos\" Hospital  Athens Greece"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Richard","family":"Torres","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine Yale University School of Medicine  New Haven Connecticut USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1743-3454","authenticated-orcid":false,"given":"Fiona E.","family":"Craig","sequence":"additional","affiliation":[{"name":"Division of Hematopathology Mayo Clinic Arizona  Phoenix Arizona USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2020,10,28]]},"reference":[{"key":"e_1_2_3_2_1","doi-asserted-by":"publisher","DOI":"10.1002\/cyto.a.22717"},{"key":"e_1_2_3_3_1","volume-title":"Validation of assays performed by flow Cytometry","author":"CLSI","year":"2020"},{"key":"e_1_2_3_4_1","article-title":"It is time to adopt a multicolor immunophenotyping approach to evaluate blood for S\u00e9zary syndrome and mycosis fungoides","author":"Craig F. 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