文章：

多中心验证经典单核细胞比例流量测定在慢性粒单核细胞白血病诊断中的应用

Multicenter validation of the flow measurement of classical monocyte fraction for chronic myelomonocytic leukemia diagnosis

原文发布日期：2018-11-14

DOI: 10.1038/s41408-018-0146-8

类型: Article

开放获取: 是

英文摘要：

Peripheral blood monocytes include three subsets defined by CD14 and CD16 surface markers. An increase in the CD14++CD16− classical monocyte fraction ≥ 94% of the total monocytes was proposed to rapidly and efficiently distinguish chronic myelomonocytic leukemia from reactive monocytosis. The robustness of this assay required a multicenter validation. The flow cytometry assay designed to quantify peripheral blood monocyte subsets was implemented by multiple diagnosis laboratories in France. A nationwide survey was performed to evaluate its performance. All the 48 French laboratories answered the questionnaire, revealing that 63% use this assay routinely. Central blind reanalysis of 329 cytometry files collected from five laboratories demonstrated an excellent correlation in classical monocyte fraction measurement (r = 0.93; p < 0.0001). The cutoff value of 94% classical monocytes being the critical readout for diagnosis, we then compared 115 patients with classical monocytes ≥ 94% and 214 patients with a fraction < 94% between initial analysis and reanalysis. An agreement was obtained in 311 files. Finally, an overt diagnosis, available for 86 files, confirmed a good sensitivity (93.6%) and specificity (89.7%). This survey demonstrates the robustness of the flow assay with limited variability of classical monocyte percentage between centers, validates the 94% cutoff value, and confirms its sensitivity and specificity.

摘要翻译： 

外周血单核细胞包括根据CD14和CD16表面标记定义的三个亚群。研究发现，当CD14++CD16−经典单核细胞比例增至总单核细胞的94%及以上时，可快速有效区分慢性粒-单核细胞白血病与反应性单核细胞增多。该检测方法的可靠性需通过多中心验证得以确认。法国多家诊断实验室实施了旨在量化外周血单核细胞亚群的流式细胞术检测方案。一项全国性评估显示，48家法国实验室全部参与问卷调查，其中63%已常规开展该检测。对五家实验室收集的329份流式细胞数据文件进行中心盲法重新分析，结果显示经典单核细胞比例测量具有极佳相关性（r=0.93；p<0.0001）。以94%经典单核细胞作为诊断临界值，我们比较了115例经典单核细胞≥94%患者与214例<94%患者的初次分析与再次分析结果，311份数据文件结果一致。最终对86份有明确诊断的文件进行验证，证实该方法具有良好的敏感性（93.6%）和特异性（89.7%）。本研究表明该流式检测方法稳健可靠，各中心间经典单核细胞百分比变异有限，验证了94%临界值的有效性，并确认其诊断敏感性与特异性。

原文链接：

Multicenter validation of the flow measurement of classical monocyte fraction for chronic myelomonocytic leukemia diagnosis