CHU de St Etienne, Laboratoire d'hématologie, Saint-Etienne, France.
CHU Vaudois-Lausanne, Laboratoire d'hématologie, Lausanne, Switzerland.
Cytometry A. 2019 Sep;95(9):1008-1018. doi: 10.1002/cyto.a.23844. Epub 2019 Jul 31.
Flow cytometry is broadly used for the identification, characterization, and monitoring of hematological malignancies. However, the use of clinical flow cytometry is restricted by its lack of reproducibility across multiple centers. Since 2006, the EuroFlow consortium has been developing a standardized procedure detailing the whole process from instrument settings to data analysis. The FranceFlow group was created in 2010 with the intention to educate participating centers in France about the standardized instrument setting protocol (SOP) developed by the EuroFlow consortium and to organise several rounds of quality controls (QCs) in order to evaluate the feasibility of its application and its results. Here, we report the 5 year experience of the FranceFlow group and the results of the seven QCs of 23 instruments, involving up to 19 centers, in France and in Belgium. The FranceFlow group demonstrates that both the distribution and applicability of the SOP have been successful. Intercenter reproducibility was evaluated using both normal and pathological blood samples. Coefficients of variation (CVs) across the centers were <7% for the percentages of cell subsets and <30% for the median fluorescence intensities (MFIs) of the markers tested. Intracenter reproducibility provided similar results with CVs of <3% for the percentages of the majority of cell subsets, and CVs of <20% for the MFI values for the majority of markers. Altogether, the FranceFlow group show that the 19 participating labs might be considered as one unique laboratory with 23 identical flow cytometers able to reproduce identical results. Therefore, SOP significantly improves reproducibility of clinical flow in hematology and opens new avenues by providing a robust companion diagnostic tool for clinical trials in hematology. © 2019 International Society for Advancement of Cytometry.
流式细胞术广泛用于血液系统恶性肿瘤的鉴定、特征描述和监测。然而，由于其缺乏在多个中心之间的可重复性，临床流式细胞术的应用受到限制。自 2006 年以来，EuroFlow 联盟一直在开发一种标准化程序，详细描述从仪器设置到数据分析的整个过程。2010 年成立了 FranceFlow 小组，目的是教育法国参与中心了解 EuroFlow 联盟开发的标准化仪器设置方案（SOP），并组织几轮质量控制（QC），以评估其应用的可行性及其结果。在这里，我们报告了 FranceFlow 小组的 5 年经验，以及对涉及法国和比利时多达 19 个中心的 23 台仪器的 7 次 QC 的结果。FranceFlow 小组表明，SOP 的分布和适用性均取得了成功。使用正常和病理血液样本评估了中心间的可重复性。细胞亚群百分比的中心间变异系数（CV）<7%，所测试标志物的中荧光强度（MFI）的 CV<30%。中心内的可重复性提供了类似的结果，大多数细胞亚群的百分比的 CV<3%，大多数标志物的 MFI 值的 CV<20%。总之，FranceFlow 小组表明，19 个参与实验室可以被视为一个具有 23 台相同流式细胞仪的独特实验室，能够复制相同的结果。因此，SOP 显著提高了血液学临床流式的可重复性，并通过为血液学临床试验提供强大的伴随诊断工具开辟了新的途径。国际细胞分析促进协会 2019 年。
