标准摘要
[中文适用范围]： 本文件提供了一种通过一系列稀释实验设计和统计分析得出的质量指标来评估特定细胞制剂的细胞计数测量过程质量的方法。 质量指标基于测量的重复性以及结果与稀释的理想比例响应的符合程度。 该方法适用于全细胞计数、微分细胞计数、直接细胞计数和间接细胞计数测量过程，前提是测量过程满足实验设计的标准（例如细胞悬浮在溶液中）。 该方法最适合细胞计数方法的开发、优化、验证、评估和/或细胞计数测量过程的验证。 该方法特别适用于无法轻易获得评估准确性的适当参考材料的情况。 该方法不直接提供细胞计数的准确性。 该方法主要适用于真核细胞。 注：存在一些特定于行业/应用的细胞计数国际和国家标准。 在适用的情况下，在现有标准范围内操作时查阅现有标准可能会有所帮助。 [外文原描述]： This document provides a method for evaluating aspects of the quality of a cell counting measurement process for a specific cell preparation through a set of quality indicators derived from a dilution series experimental design and statistical analysis. The quality indicators are based on repeatability of the measurement and the degree to which the results conform to an ideal proportional response to dilution. This method is applicable to total, differential, direct and indirect cell counting measurement processes, provided that the measurement process meets the criteria of the experimental design (e.g. cells are suspended in a solution). This method is most suitable during cell counting method development, optimization, validation, evaluation and/or verification of cell counting measurement processes. This method is especially applicable in cases where an appropriate reference material to assess accuracy is not readily available. This method does not directly provide the accuracy of the cell count. This method is primarily applicable to eukaryotic cells. NOTE Several sector/application specific international and national standards for cell counting exist. Where applicable, consulting existing standards when operating within their scope can be helpful.
英文名称Biotechnology — Cell counting — Part 2: Experimental design and statistical analysis to quantify counting method performance