The current consensus recommendation papers dealing with the unique requirements for the analytical validation of assays performed by flow cytometry address the validation of sensitivity (both analytical and functional) only in general terms. In this paper, a detailed approach for designing and validating the sensitivity of rare event methods is described. The impact of panel design and optimization on the lower limit of quantification (LLOQ) and suggestions for reporting data near, or below, the LLOQ are addressed. This paper serves to provide best practices for the development, optimization, and analytical validation of flow cytometric assays designed to assess rare events. Note that this paper does not discuss clinical sensitivity validation, which addresses the positive and negative predictive value of the test result.

中文翻译：

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高灵敏度流式细胞仪检测：用于识别罕见事件的设计控制和分析验证的考虑因素。

当前关于流式细胞仪分析验证的独特要求的共识推荐文件仅笼统地解决了灵敏度（分析和功能）的验证。在本文中，描述了一种设计和验证罕见事件方法灵敏度的详细方法。解决了面板设计和优化对量化下限 (LLOQ) 的影响以及报告接近或低于 LLOQ 的数据的建议。本文旨在为旨在评估罕见事件的流式细胞仪检测的开发、优化和分析验证提供最佳实践。请注意，本文不讨论临床敏感性验证，它涉及测试结果的阳性和阴性预测值。