Using flow cytometry for paediatric leukaemia diagnosis in Kenya: a protocol for mixed methods study

Area of Science:

• Hematology
• Oncology
• Medical Diagnostics

Background:

• Childhood cancer diagnosis in western Kenya faces significant delays, with leukaemia being a major concern.
• Flow cytometry is crucial for leukaemia diagnosis but is underutilized in sub-Saharan Africa due to cost, equipment, and training limitations.
• Existing cytometers in Kenya are outdated, necessitating the exploration of newer, more sustainable diagnostic platforms.

Purpose of the Study:

• To evaluate the diagnostic accuracy of a streamlined, single-tube flow cytometry assay compared to a standard multi-tube assay.
• To assess the feasibility of implementing this assay within a referral system using peripheral blood samples.
• To measure the effectiveness of a regional educational initiative on improving diagnostic knowledge and skills.

Main Methods:

• A prospective, mixed-methods study comparing a 1-tube assay (ClearLLab LS) with a 4-tube assay (ClearLLab 10C) using paired bone marrow and peripheral blood samples.
• Evaluating the logistics of transporting peripheral blood samples from referral sites across western Kenya.
• Assessing training effectiveness via surveys, knowledge tests, and interviews using the Project ECHO model.

Main Results:

• The study aims to measure diagnostic concordance, sensitivity, and specificity between the two flow cytometry assays.
• Feasibility of sample transport and referral logistics will be quantitatively and qualitatively assessed.
• The impact of the educational program on participants' knowledge gain will be measured.

Conclusions:

• This research protocol outlines a strategy to implement and evaluate a simplified flow cytometry assay for improved leukaemia diagnosis in Kenya.
• The study seeks to enhance diagnostic capacity and address critical gaps in childhood cancer care in low-resource settings.
• Findings will inform the scalable and sustainable integration of advanced diagnostic tools in regional healthcare.