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

Millicent Orido, Teresa Cherop Lotodo, Nicholas Kigen, Ryan Stohler, Terry A Vik, Gail H Vance
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Abstract

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.

在肯尼亚西部的一家公立医院引入慢性髓系白血病的诊断检测。
上下文。慢性髓系白血病(CML)是一种以粒细胞增生为特征的骨髓增殖性疾病。据估计,肯尼亚CML的发病率每年接近2000例。如果不进行治疗,这种疾病的预后很差。酪氨酸激酶抑制剂被批准用于成人和儿童确诊疾病的治疗。在肯尼亚,公共场所对慢性粒细胞白血病的诊断检测是有限的,并且不在肯尼亚国家健康保险基金的覆盖范围内。-:在肯尼亚埃尔多雷特的学术模型提供医疗保健(AMPATH)参考实验室建立CML诊断的临床荧光原位杂交试验。外周血和骨髓涂片在AMPATH参考实验室和印第安纳大学细胞遗传学实验室进行一致性研究。-:在AMPATH和印第安纳大学细胞遗传学实验室用荧光原位杂交技术研究了17例临时诊断为CML的患者标本。1个标本的分析不能由两个实验室完成,另外1个标本的分析结果不一致。16份标本中有15份解释一致,占93.7%。对正常标本也进行了研究,以确定测定的正常范围。-:我们报告在肯尼亚埃尔多雷特的AMPATH参考实验室和Moi教学和转诊医院建立CML诊断测试。
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