Introducing a sensitive and specific peripheral blood flow cytometric assay for Sézary syndrome and mycosis fungoides (SS/MF) requires careful selection of assay design characteristics, and translation into a laboratory developed assay through development/optimization, validation, and continual quality monitoring. As outlined in a previous article in this series, the recommended design characteristics of this assay include at a minimum, evaluation of CD7, CD3, CD4, CD8, CD26, and CD45, analyzed simultaneously, requiring at least a 6 color flow cytometry system, with both quantitative and qualitative components. This article provides guidance from an international group of cytometry specialists in implementing an assay to those design specifications, outlining specific considerations, and best practices. Key points presented in detail are: (a) Pre‐analytic components (reagents, specimen processing, and acquisition) must be optimized to: (i) identify and characterize an abnormal population of T‐cells (qualitative component) and (ii) quantitate the abnormal population (semi/quasi‐quantitative component). (b)Analytic components (instrument set‐up/acquisition/analysis strategy and interpretation) must be optimized for the identification of SS/MF populations, which can vary widely in phenotype. Comparison with expert laboratories is strongly encouraged in order to establish competency. (c) Assay performance must be validated and documented through a validation plan and report, which covers both qualitative and semi/quasi‐quantitative assay components (example template provided). (d) Ongoing assay‐specific quality monitoring should be performed to ensure consistency.

中文翻译：

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外周血流式细胞术评估疑似 Sézary 综合征或蕈样真菌病的国际指南：检测开发/优化、验证和持续质量监测

为 Sézary 综合征和蕈样真菌病 (SS/MF) 引入灵敏且特异的外周血流式细胞术检测需要仔细选择检测设计特征，并通过开发/优化、验证和持续质量监测转化为实验室开发的检测。如本系列前一篇文章所述，该检测的推荐设计特征至少包括评估 CD7、CD3、CD4、CD8、CD26 和 CD45，同时分析，至少需要 6 色流式细胞术系统，具有定量和定性成分。本文提供了来自一个国际细胞计数专家小组的指导，以根据这些设计规范实施检测，概述特定考虑因素和最佳实践。详细介绍的关键点是：(a) 分析前成分（试剂、样本处理和采集）必须优化以：（i）识别和表征异常 T 细胞群（定性成分）和（ii）定量异常群（半/准） -定量成分）。(b) 必须优化分析组件（仪器设置/采集/分析策略和解释）以识别 SS/MF 种群，它们的表型差异很大。强烈鼓励与专家实验室进行比较，以建立能力。(c) 分析性能必须通过验证计划和报告进行验证和记录，其中涵盖定性和半/准定量分析组件（提供示例模板）。(d) 应进行持续的特定于检测的质量监测以确保一致性。