{
  "abstract": "Introduction 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the WHO considers essential for leukaemia diagnosis, remains underused across sub-Saharan Africa due to high costs, outdated equipment and a lack of trained personnel. In Kenya, decades-old cytometers have been adapted for leukaemia detection, but these systems are now outdated.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.Methods and analysis 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.Ethics and dissemination 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.",
  "authors": [
    {
      "affiliations": [
        "Department of Pediatrics, University of Missouri School of Medicine, Columbia, Missouri, USA"
      ],
      "name": "Tyler Severance"
    },
    {
      "affiliations": [
        "Moi University, Eldoret, Kenya"
      ],
      "name": "Teresa Lotodo"
    },
    {
      "affiliations": [
        "Directorate of Pathology, Moi Teaching and Referral Hospital, Eldoret, Kenya"
      ],
      "name": "Enock Serem"
    },
    {
      "affiliations": [
        "Department of Child Health and Pediatrics, Moi University School of Medicine, Eldoret, Kenya"
      ],
      "name": "Festus Njuguna"
    },
    {
      "affiliations": [
        "Moi Teaching and Referral Hospital, Eldoret, Kenya"
      ],
      "name": "Beatrice Melly"
    },
    {
      "affiliations": [
        "Academic Model Providing Access to Healthcare, Eldoret, Kenya"
      ],
      "name": "Millicent Orido"
    },
    {
      "affiliations": [
        "Moi University, Eldoret, Kenya"
      ],
      "name": "Ronald Tonui"
    },
    {
      "affiliations": [
        "Department of Child Health and Pediatrics, Moi Teaching and Referral Hospital, Eldoret, Kenya"
      ],
      "name": "Gilbert Olbara"
    },
    {
      "affiliations": [
        "Academic Model Providing Access to Healthcare, Eldoret, Kenya"
      ],
      "name": "Raphael Koima"
    },
    {
      "affiliations": [
        "Academic Model Providing Access to Healthcare, Eldoret, Kenya"
      ],
      "name": "Nicholas Kigen"
    },
    {
      "affiliations": [
        "Burkitt’s Lymphoma Fund for Africa, Seattle, Washington, USA"
      ],
      "name": "Steven Kussick"
    },
    {
      "affiliations": [
        "Burkitt’s Lymphoma Fund for Africa, Seattle, Washington, USA"
      ],
      "name": "Vicki Ratliff"
    },
    {
      "affiliations": [
        "Beckman Coulter Life Sciences, Indianapolis, Indiana, USA"
      ],
      "name": "Eda Holl"
    },
    {
      "affiliations": [
        "Biostatistics Department, Indiana University School of Medicine, Indianapolis, Indiana, USA"
      ],
      "name": "Patrick O Monahan"
    },
    {
      "affiliations": [
        "Beckman Coulter Life Sciences, Indianapolis, Indiana, USA"
      ],
      "name": "Tony Boova"
    },
    {
      "affiliations": [
        "Department of Pediatrics, Indiana University School of Medicine, Indianapolis, Indiana, USA"
      ],
      "name": "Terry Vik"
    }
  ],
  "title": "Using flow cytometry for paediatric leukaemia diagnosis in Kenya: a protocol for mixed methods study",
  "uid": "a310b3b9-e950-5b42-8172-29950f453d8f"
}