# 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

> **NIH NIH R01** · INDIANA UNIVERSITY INDIANAPOLIS · 2024 · $521,488

## Abstract

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.

## Key facts

- **NIH application ID:** 10883207
- **Project number:** 1R01CA278862-01A1
- **Recipient organization:** INDIANA UNIVERSITY INDIANAPOLIS
- **Principal Investigator:** TERRY A VIK
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $521,488
- **Award type:** 1
- **Project period:** 2024-07-02 → 2029-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10883207

## Citation

> US National Institutes of Health, RePORTER application 10883207, 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 (1R01CA278862-01A1). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10883207. Licensed CC0.

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