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sub-Saharan Africa due to high costs, outdated equipment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these systems are now outdated.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.
