Adapting flow cytometry methods for early detection of acute hematologic malignancies in Kenya including the improvement of sample flow processes and technical training of personnel

The ability to diagnose and classify leukemias and lymphomas (LLs), in children and young adults is limited in Kenya and most of Sub-Saharan Africa. LLs represent nearly half the cancers in this population. Flow cytometry (FC) offers a major advantage in leukemia diagnosis. The only center that has implemented flow cytometry in western Kenya to diagnose LLs is based in the AMPATH reference laboratory (ARL). A major gap in cancer care in Kenya is the lack of cost-effective screening tests for leukemia and lymphoma. The only option for patients with suspected LLs is to travel to the ARL in Eldoret and pay out of pocket for expensive diagnostic services, including FC. The current FC workflow in the ARL uses a four-tube, ten-color fluorescent antibody testing in which four separate assays are needed per patient. We hypothesize that we can convert our current four-tube process on bone marrow, to a better process utilizing peripheral blood samples in a single-tube FC screening assay, with additional testing for only a small minority of patients with evidence of malignancy that cannot be resolved by our single tube assay. This low-cost test will increase accessibility, as a blood sample can be transported to the lab instead of the patient traveling for a bone marrow procedure. Our aims for this proposal are to: 1: Validate and measure the concordance of three flow cytometry tests comparing bone marrow aspiration and peripheral blood (PB) from patients in our hospital with suspected leukemia. We will measure the concordance of our current gold standard, four-tube method for leukemia diagnosis on bone marrow samples with a new, ten-color, single tube dry, unitized reagent assays (DURA) ClearLLab® LS single tube designed for lymphoid and myeloid malignancy screening and diagnosis. Simultaneously, we will measure the concordance of the LS single-tube assay on bone marrow with the same assay using peripheral blood to demonstrate the equivalence of those two methods. 2: Establish and validate an adapted flow cytometry assay for leukemia diagnosis in distant, peripheral facilities in Kenya. We will identify patients with suspected leukemia in our partner peripheral facilities and transport PB samples to the ARL for analysis by flow cytometry and expand our reach for simplifying diagnosis without the need for bone marrow sampling or transporting patients to the hospital first, thereby adding to the efficiency of the process. 3: Develop a comprehensive educational model to ensure short- and long-term implementation of flow cytometry in the region. With support from medical experts in the United States and Beckman-Coulter, ARL staff will then implement a comprehensive training program featuring on-site training, continuous telehealth education (Project ECHO), and an asynchronous learning management system (Kaluza, Cytobank) to ensure continued effective utilization and sustainability of Flow Cytometry.