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通过流式细胞术实现慢性淋巴细胞白血病的可重现诊断:欧洲慢性淋巴细胞白血病研究倡议(ERIC)和欧洲临床细胞分析学会(ESCCA)的一项协调项目。

Reproducible diagnosis of chronic lymphocytic leukemia by flow cytometry: An European Research Initiative on CLL (ERIC) & European Society for Clinical Cell Analysis (ESCCA) Harmonisation project.

机构信息

St. James's Institute of Oncology, Leeds, UK.

Universitätsklinikum Köln, Köln, Germany.

出版信息

Cytometry B Clin Cytom. 2018 Jan;94(1):121-128. doi: 10.1002/cyto.b.21595. Epub 2018 Jan 17.

Abstract

The diagnostic criteria for CLL rely on morphology and immunophenotype. Current approaches have limitations affecting reproducibility and there is no consensus on the role of new markers. The aim of this project was to identify reproducible criteria and consensus on markers recommended for the diagnosis of CLL. ERIC/ESCCA members classified 14 of 35 potential markers as "required" or "recommended" for CLL diagnosis, consensus being defined as >75% and >50% agreement, respectively. An approach to validate "required" markers using normal peripheral blood was developed. Responses were received from 150 participants with a diagnostic workload >20 CLL cases per week in 23/150 (15%), 5-20 in 82/150 (55%), and <5 cases per week in 45/150 (30%). The consensus for "required" diagnostic markers included: CD19, CD5, CD20, CD23, Kappa, and Lambda. "Recommended" markers potentially useful for differential diagnosis were: CD43, CD79b, CD81, CD200, CD10, and ROR1. Reproducible criteria for component reagents were assessed retrospectively in 14,643 cases from 13 different centers and showed >97% concordance with current approaches. A pilot study to validate staining quality was completed in 11 centers. Markers considered as "required" for the diagnosis of CLL by the participants in this study (CD19, CD5, CD20, CD23, Kappa, and Lambda) are consistent with current diagnostic criteria and practice. Importantly, a reproducible approach to validate and apply these markers in individual laboratories has been identified. Finally, a consensus "recommended" panel of markers to refine diagnosis in borderline cases (CD43, CD79b, CD81, CD200, CD10, and ROR1) has been defined and will be prospectively evaluated. © 2017 International Clinical Cytometry Society.

摘要

CLL 的诊断标准依赖于形态学和免疫表型。目前的方法存在影响可重复性的局限性,并且对于新标记物的作用尚无共识。本项目的目的是确定可重复性标准,并就推荐用于 CLL 诊断的标记物达成共识。ERIC/ESCCA 成员将 35 个潜在标记物中的 14 个归类为“必需”或“推荐”用于 CLL 诊断,分别定义为>75%和>50%的一致性。开发了一种使用正常外周血验证“必需”标记物的方法。收到了来自 150 名参与者的回复,他们的诊断工作量每周有超过 20 例 CLL 病例(15%),5-20 例(55%),每周不到 5 例(30%)。对于“必需”诊断标记物的共识包括:CD19、CD5、CD20、CD23、Kappa 和 Lambda。“推荐”用于鉴别诊断的潜在有用标记物包括:CD43、CD79b、CD81、CD200、CD10 和 ROR1。在来自 13 个不同中心的 14643 例病例中,回顾性评估了用于组成试剂的可重复性标准,结果与当前方法的一致性>97%。在 11 个中心完成了验证染色质量的试点研究。本研究参与者认为“必需”用于 CLL 诊断的标记物(CD19、CD5、CD20、CD23、Kappa 和 Lambda)与当前的诊断标准和实践一致。重要的是,已经确定了一种在各个实验室中验证和应用这些标记物的可重复方法。最后,还定义了一个共识“推荐”标记物面板,以在边缘病例中细化诊断(CD43、CD79b、CD81、CD200、CD10 和 ROR1),并将进行前瞻性评估。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/42a0/5817234/141dd45afc57/CYTO-94-121-g001.jpg

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