Standardization of Flow Cytometric Minimal Residual Disease Evaluation in Acute Lymphoblastic Leukemia: Multicentric Assessment Is Feasible
Standardization of Flow Cytometric Minimal Residual Disease Evaluation in Acute Lymphoblastic Leukemia: Multicentric Assessment Is Feasible
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DOI：
10.1002/cyto.b.20430
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发表时间：
2008-11-01
影响因子：
3.4
通讯作者：
Basso, Giuseppe
中科院分区：
文献类型：
--
作者：
Dworzak, Michael Norbert;Gaipa, Giuseppe;Basso, Giuseppe
工作背景：单一实验室的经验表明，流式细胞术（FCM）评估急性淋巴细胞白血病（ALL）的微小残留病（MRD）在大多数患者是可行的，并提供独立的预后信息。它是，但是，不知道是否FCM分析可以可靠地标准化为multicentric application.Methods：一个广泛的标准化程序安装在四个合作实验室，研究FCM-MRD在儿童治疗的AIEOP-BFM-ALL 2000协议。这包括方法上的一致性、持续的质量监测以及通过交流和业绩反馈进行的人员教育。列表模式数据解读一致性的设盲实验室间检验（n = 202份血液和骨髓样本，来自诱导期间随机选择的31名患者的随访，总系列n = 395）显示了非常高的内部-尽管细胞计数器和软件使用存在差异，但四个中心之间的评分员一致性（基于n = 800个单个值的组内相关系数[ICC] 0.979）。MRD低于0.1%时，一致性较低。比较样本交换实验（n = 42个样本; ICC 0.98）和来自四个中心的独立患者队列（关于每个随访时间点的阳性样本以及风险估计）的数据，一致性也很好。结论：可以标准化FCM对ALL的MRD评估，以在大型试验中进行可靠的多中心评估。(C)2008年临床细胞计数学会
Background: Single-laboratory experience showed that flow cytometric (FCM) assessment of minimal residual disease (MRD) in acute lymphoblastic leukemia (ALL) is feasible in most patients and gives independent prognostic information. It is, however, not known whether FCM analysis can reliably be standardized for multicentric application.Methods: An extensive standardization program was installed in four collaborating laboratories, which study FCM-MRD in children treated with the AIEOP-BFM-ALL 2000 protocol. This included methodological alignment, continuous quality monitoring, as well as personnel education by exchange and performance feed-back.Results: Blinded inter-laboratory tests of list-mode data interpretation concordance (n = 202 blood and bone marrow samples from follow-up during induction of 31 randomly selected patients of a total series of n = 395) showed a very high degree of inter-rater agreement among the four centers despite differences in cytometers and software usage (intraclass correlation coefficient [ICC] 0.979 based on n = 800 single values). Lower concordance was reached with amounts of MRD below 0.1%. Comparing data from sample exchange experiments (n = 42 samples; ICC 0.98) and from independent patient cohorts from the four centers (regarding positive samples per time-point of follow-up as well as risk estimates) concordance was also good.Conclusion: MRD-evaluation by FCM in ALL can be standardized for reliable multicentric assessment in large trials. (C) 2008 Clinical Cytometry Society