以半自动化识别正常造血细胞为手段，在B细胞前体急性淋巴细胞白血病中对极小残留病负荷进行评估：一项EuroFlow研究。
Minimal residual disease assessment in B-cell precursor acute lymphoblastic leukemia by semi-automated identification of normal hematopoietic cells: A EuroFlow study.
发表日期：2023 Sep 22
作者：
Martijn W C Verbeek, Beatriz Soriano Rodríguez, Lukasz Sedek, Anna Laqua, Chiara Buracchi, Malicorne Buysse, Michaela Reiterová, Elen Oliveira, Daniela Morf, Sjoerd R Oude Alink, Susana Barrena, Saskia Kohlscheen, Stefan Nierkens, Mattias Hofmans, Paula Fernandez, Elaine Sobral de Costa, Ester Mejstrikova, Tomasz Szczepanski, Lukasz Slota, Monika Brüggemann, Giuseppe Gaipa, Georgiana Grigore, Jacques J M van Dongen, Alberto Orfao, Vincent H J van der Velden
来源：
Bone & Joint Journal
摘要：
B细胞前体急性淋巴细胞白血病（BCP-ALL）中通过流式细胞术检测到的最小残留疾病（MRD）是管理该病的重要预后生物标志物。然而，数据分析仍然主要依赖专家。在本研究中，我们设计并验证了一种自动门控与识别（AGI）工具，用于使用EuroFlow 8色MRD组套的两个管样对BCP-ALL患者进行MRD分析。AGI工具的准确性、重复性和再现性在一项多中心研究中得到验证，该研究使用来自174个BCP-ALL患者的骨髓后续样本，并使用EuroFlow BCP-ALL MRD组套进行染色。在这些患者中，通过手动分析和AGI工具辅助分析评估了MRD。比较这两种方法获得的MRD水平，显示出83%的一致性率，MRD管1、2或两者之间、治疗方案（化疗与靶向治疗）以及流式细胞计数器（FACSCanto与FACSLyric）之间的一致性相当。在其他专家的审查后，不一致案例的一致性提高到97%。此外，AGI工具显示出优秀的内部专家一致性（100%）和良好的专家间一致性（90%）。除了MRD水平外，正常细胞群体的百分比在手动和AGI工具分析之间也显示出极好的一致性。我们得出结论，AGI工具可以促进使用EuroFlow BCP-ALL MRD方案进行MRD分析，并有助于更加标准化和客观的MRD评估。然而，需要适当的培训来正确分析MRD数据。© 2023 The Authors. Cytometry Part B: Clinical Cytometry由Wiley Periodicals LLC代表International Clinical Cytometry Society出版。
Presence of minimal residual disease (MRD), detected by flow cytometry, is an important prognostic biomarker in the management of B-cell precursor acute lymphoblastic leukemia (BCP-ALL). However, data-analysis remains mainly expert-dependent. In this study, we designed and validated an Automated Gating & Identification (AGI) tool for MRD analysis in BCP-ALL patients using the two tubes of the EuroFlow 8-color MRD panel. The accuracy, repeatability, and reproducibility of the AGI tool was validated in a multicenter study using bone marrow follow-up samples from 174 BCP-ALL patients, stained with the EuroFlow BCP-ALL MRD panel. In these patients, MRD was assessed both by manual analysis and by AGI tool supported analysis. Comparison of MRD levels obtained between both approaches showed a concordance rate of 83%, with comparable concordances between MRD tubes (tube 1, 2 or both), treatment received (chemotherapy versus targeted therapy) and flow cytometers (FACSCanto versus FACSLyric). After review of discordant cases by additional experts, the concordance increased to 97%. Furthermore, the AGI tool showed excellent intra-expert concordance (100%) and good inter-expert concordance (90%). In addition to MRD levels, also percentages of normal cell populations showed excellent concordance between manual and AGI tool analysis. We conclude that the AGI tool may facilitate MRD analysis using the EuroFlow BCP-ALL MRD protocol and will contribute to a more standardized and objective MRD assessment. However, appropriate training is required for the correct analysis of MRD data.© 2023 The Authors. Cytometry Part B: Clinical Cytometry published by Wiley Periodicals LLC on behalf of International Clinical Cytometry Society.