Introducing Diagnostic Testing for Chronic Myeloid Leukemia in a Public Hospital Setting in Western Kenya.

CONTEXT.—: Chronic myeloid leukemia (CML) is a myeloproliferative disorder characterized by proliferation of the granulocytic cell line. The incidence of CML in Kenya is estimated at near 2000 cases annually. The disorder is associated with a poor prognosis without treatment. Tyrosine kinase inhibitors are approved for treatment in adults and children with confirmed disease. Diagnostic testing for CML in the public setting in Kenya is limited and not covered by the Kenyan National Health Insurance Fund.

OBJECTIVE.—: To establish a clinical fluorescence in situ hybridization assay for the diagnosis of CML in the Academic Model Providing Access to Healthcare (AMPATH) Reference Laboratory in Eldoret, Kenya.

DESIGN.—: Peripheral blood and bone marrow smears were split between the AMPATH Reference Laboratory and the Indiana University Cytogenetics Laboratory for concordance studies.

RESULTS.—: Seventeen specimens from patients with a provisional diagnosis of CML were studied by fluorescence in situ hybridization in both the AMPATH and Indiana University Cytogenetics laboratories. The analysis for 1 specimen could not be completed by both laboratories, and the results for 1 other specimen were discordant. The interpretations of 15 of 16 specimens (93.7%) were concordant. Normal specimens were also studied to establish the normal range for the assay.

CONCLUSIONS.—: We report the establishment of diagnostic testing for CML in the AMPATH Reference Laboratory and the Moi Teaching and Referral Hospital in Eldoret, Kenya.