{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,19]],"date-time":"2026-03-19T02:34:33Z","timestamp":1773887673047,"version":"3.50.1"},"reference-count":22,"publisher":"BMJ","issue":"3","license":[{"start":{"date-parts":[[2026,3,16]],"date-time":"2026-03-16T00:00:00Z","timestamp":1773619200000},"content-version":"unspecified","delay-in-days":15,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100000054","name":"National Cancer Institute","doi-asserted-by":"publisher","award":["1R01CA278862-01A1"],"award-info":[{"award-number":["1R01CA278862-01A1"]}],"id":[{"id":"10.13039\/100000054","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2026,3,4]]},"published-print":{"date-parts":[[2026,3]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Each year, an estimated 1700 children should be diagnosed with cancer in western Kenya, with leukaemia making up nearly one-third of cases. However, far fewer are actually diagnosed, highlighting significant delays or errors in diagnosis. Flow cytometry, which the WHO considers essential for leukaemia diagnosis, remains underused across sub-Saharan Africa due to high costs, outdated equipment and a lack of trained personnel. In Kenya, decades-old cytometers have been adapted for leukaemia detection, but these systems are now outdated. Newer platforms, such as simplified single-tube multiparametric assays, provide a scalable and sustainable alternative. This study presents a protocol to evaluate the accuracy of diagnosis and the potential for implementing a streamlined flow cytometry assay using peripheral blood, supported by a regional educational initiative.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>This prospective, mixed-methods implementation study has three aims: (1) to assess the concordance between the Beckman Coulter ClearLLab 10C gold standard 4-tube assay and the streamlined ClearLLab LS 1-tube assay using paired bone marrow and peripheral blood samples; (2) to evaluate the feasibility of peripheral facility referrals and transport logistics with couriered peripheral blood samples from referring sites across western Kenya; and (3) to measure training effectiveness and knowledge gain through a multimodal educational programme using the Project ECHO (Extension for Community Healthcare Outcomes) model. Up to 300 patients at Moi Teaching and Referral Hospital in Eldoret, Kenya, will be enrolled in Aim 1. A separate sample of 100 patients from peripheral facilities will be included in Aim 2. Surveys, knowledge assessments and structured interviews will be used to evaluate training impact under Aim 3. Diagnostic concordance, sensitivity, specificity and knowledge gain will be measured through appropriate quantitative and qualitative methods.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>The protocol has received approval from institutional ethics committees at Moi University, MTRH and Indiana University. De-identified data will be analysed and shared through peer-reviewed publications, stakeholder presentations and educational platforms.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2026-117499","type":"journal-article","created":{"date-parts":[[2026,3,18]],"date-time":"2026-03-18T21:56:11Z","timestamp":1773870971000},"page":"e117499","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":0,"title":["Using flow cytometry for paediatric leukaemia diagnosis in Kenya: a protocol for mixed methods study"],"prefix":"10.1136","volume":"16","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5885-9780","authenticated-orcid":false,"given":"Tyler","family":"Severance","sequence":"first","affiliation":[{"name":"Department of Pediatrics, University of Missouri School of Medicine, Columbia, Missouri, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Teresa","family":"Lotodo","sequence":"additional","affiliation":[{"name":"Moi University, Eldoret, Kenya"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9258-3172","authenticated-orcid":false,"given":"Enock","family":"Serem","sequence":"additional","affiliation":[{"name":"Directorate of Pathology, Moi Teaching and Referral Hospital, Eldoret, Kenya"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Festus","family":"Njuguna","sequence":"additional","affiliation":[{"name":"Department of Child Health and Pediatrics, Moi University School of Medicine, Eldoret, Kenya"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Beatrice","family":"Melly","sequence":"additional","affiliation":[{"name":"Moi Teaching and Referral Hospital, Eldoret, Kenya"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Millicent","family":"Orido","sequence":"additional","affiliation":[{"name":"Academic Model Providing Access to Healthcare, Eldoret, Kenya"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ronald","family":"Tonui","sequence":"additional","affiliation":[{"name":"Moi University, Eldoret, Kenya"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gilbert","family":"Olbara","sequence":"additional","affiliation":[{"name":"Department of Child Health and Pediatrics, Moi Teaching and Referral Hospital, Eldoret, Kenya"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Raphael","family":"Koima","sequence":"additional","affiliation":[{"name":"Academic Model Providing Access to Healthcare, Eldoret, Kenya"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nicholas","family":"Kigen","sequence":"additional","affiliation":[{"name":"Academic Model Providing Access to Healthcare, Eldoret, Kenya"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Steven","family":"Kussick","sequence":"additional","affiliation":[{"name":"Burkitt\u2019s Lymphoma Fund for Africa, Seattle, Washington, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Vicki","family":"Ratliff","sequence":"additional","affiliation":[{"name":"Burkitt\u2019s Lymphoma Fund for Africa, Seattle, Washington, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Eda","family":"Holl","sequence":"additional","affiliation":[{"name":"Beckman Coulter Life Sciences, Indianapolis, Indiana, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Patrick O","family":"Monahan","sequence":"additional","affiliation":[{"name":"Biostatistics Department, Indiana University School of Medicine, Indianapolis, Indiana, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tony","family":"Boova","sequence":"additional","affiliation":[{"name":"Beckman Coulter Life Sciences, Indianapolis, Indiana, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Terry","family":"Vik","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Indiana University School of Medicine, Indianapolis, Indiana, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2026,3,18]]},"reference":[{"key":"2026031814554290000_16.3.e117499.1","unstructured":"Kenya population and housing census, volume I: population by County and Sub-County. 2019."},{"key":"2026031814554290000_16.3.e117499.2","unstructured":"Krapcho M , Miller D , Brest A , et al , eds. SEER cancer statistics review, 1975-2017. Bethesda, MD: Institute NC, 2020."},{"key":"2026031814554290000_16.3.e117499.3","unstructured":"Mackay J , Society AC . The cancer atlas. American Cancer Society; 2006."},{"key":"2026031814554290000_16.3.e117499.4","doi-asserted-by":"publisher","DOI":"10.1016\/S1470-2045(17)30186-9"},{"key":"2026031814554290000_16.3.e117499.5","unstructured":"World Health O . WHO list of priority medical devices for cancer management. Geneva World Health Organization; 2017."},{"key":"2026031814554290000_16.3.e117499.6","first-page":"72","article-title":"Use of Flow Cytometry Immunophenotyping for Diagnosis of Acute Leukemia at Moi Teaching and Referral Hospital, Eldoret, Kenya Optimal chemotherapy for leukemia: a model-based strategy for individualized treatment","volume":"13","author":"Patel","year":"2014","journal-title":"Am Sci Res J Eng"},{"key":"2026031814554290000_16.3.e117499.7","doi-asserted-by":"publisher","DOI":"10.1007\/s11606-007-0437-4"},{"key":"2026031814554290000_16.3.e117499.8","doi-asserted-by":"crossref","unstructured":"Quigley F . Walking together, walking far: how a U.S. and African medical school partnership is winning the fight against HIV\/AIDS. Indiana University Press, 2009.","DOI":"10.2979\/5400.0"},{"key":"2026031814554290000_16.3.e117499.9","doi-asserted-by":"crossref","DOI":"10.1186\/s12992-018-0366-5","article-title":"Leveraging the power of partnerships: spreading the vision for a population health care delivery model in western Kenya","volume":"14","author":"Mercer","year":"2018","journal-title":"Global Health"},{"key":"2026031814554290000_16.3.e117499.10","doi-asserted-by":"crossref","first-page":"S33","DOI":"10.1097\/QAD.0000000000001887","article-title":"Models of integration of HIV and noncommunicable disease care in sub-Saharan Africa: lessons learned and evidence gaps","volume":"32 Suppl 1","author":"Njuguna","year":"2018","journal-title":"AIDS"},{"key":"2026031814554290000_16.3.e117499.11","doi-asserted-by":"crossref","DOI":"10.1136\/bmjpo-2017-000149","article-title":"Influence of health insurance status on paediatric non-Hodgkin\u2019s lymphoma treatment in Kenya","volume":"1","author":"Martijn","year":"2017","journal-title":"BMJ Paediatr Open"},{"key":"2026031814554290000_16.3.e117499.12","doi-asserted-by":"publisher","DOI":"10.3109\/08880018.2016.1169566"},{"key":"2026031814554290000_16.3.e117499.13","first-page":"917","article-title":"Influence of health insurance status on childhood cancer treatment outcomes in Kenya","volume":"28","author":"Olbara","year":"2020","journal-title":"Support Care Cancer"},{"key":"2026031814554290000_16.3.e117499.14","doi-asserted-by":"publisher","DOI":"10.1136\/archdischild-2013-305052"},{"key":"2026031814554290000_16.3.e117499.15","doi-asserted-by":"publisher","DOI":"10.1136\/archdischild-2011-300829"},{"key":"2026031814554290000_16.3.e117499.16","doi-asserted-by":"crossref","DOI":"10.1002\/pbc.27309","article-title":"Health-care providers\u2019 perspectives on traditional and complementary alternative medicine of childhood cancer in Kenya","volume":"65","author":"Olbara","year":"2018","journal-title":"Pediatr Blood Cancer"},{"key":"2026031814554290000_16.3.e117499.17","doi-asserted-by":"crossref","DOI":"10.1002\/pbc.29366","article-title":"Childhood acute lymphoblastic leukemia treatment in an academic hospital in Kenya: Treatment outcomes and health-care providers\u2019 perspectives","volume":"68","author":"Olbara","year":"2021","journal-title":"Pediatr Blood Cancer"},{"key":"2026031814554290000_16.3.e117499.18","doi-asserted-by":"crossref","DOI":"10.1002\/pbc.29503","article-title":"Outcomes of Wilms tumor treatment in western Kenya","volume":"69","author":"Uittenboogaard","year":"2022","journal-title":"Pediatr Blood Cancer"},{"key":"2026031814554290000_16.3.e117499.19","article-title":"Treatment outcomes of pediatric acute myeloid leukemia in Western Kenya before and after the implementation of the SIOP PODC treatment guideline","volume":"6","author":"van Weelderen","year":"2023","journal-title":"Cancer Rep (Hoboken)"},{"key":"2026031814554290000_16.3.e117499.20","doi-asserted-by":"publisher","DOI":"10.1093\/biomet\/26.4.404"},{"key":"2026031814554290000_16.3.e117499.21","doi-asserted-by":"crossref","first-page":"707","DOI":"10.1002\/cyto.b.21603","article-title":"Initial flow cytometric evaluation of the Clearllab lymphoid screen","volume":"94","author":"Hedley","year":"2018","journal-title":"Cytometry B Clin Cytom"},{"key":"2026031814554290000_16.3.e117499.22","doi-asserted-by":"crossref","DOI":"10.1002\/pbc.27453","article-title":"Peripheral blood flow cytometry for the diagnosis of pediatric acute leukemia: Highly reliable with rare exceptions","volume":"66","author":"Cheng","year":"2019","journal-title":"Pediatr Blood Cancer"}],"container-title":["BMJ Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjopen-2026-117499","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,3,18]],"date-time":"2026-03-18T21:56:15Z","timestamp":1773870975000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopen.bmj.com\/lookup\/doi\/10.1136\/bmjopen-2026-117499"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,3]]},"references-count":22,"journal-issue":{"issue":"3","published-online":{"date-parts":[[2026,3,18]]},"published-print":{"date-parts":[[2026,3]]}},"alternative-id":["10.1136\/bmjopen-2026-117499"],"URL":"https:\/\/doi.org\/10.1136\/bmjopen-2026-117499","relation":{},"ISSN":["2044-6055","2044-6055"],"issn-type":[{"value":"2044-6055","type":"print"},{"value":"2044-6055","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,3]]}}}