Abstract:
Context.—Chronic myeloid leukemia (CML) is a myelo-
proliferative 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 fluores-
cence in situ hybridization in both the AMPATH and
Indiana University Cytogenetics laboratories. The analysis
for 1 specimen could not be completed by both laborato-
ries, 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 diagnos-
tic testing for CML in the AMPATH Reference Laboratory and
the Moi Teaching and Referral Hospital in Eldoret, Kenya.