GB/T 42076.2-2025 Active

This document describes an experimental design and statistical analysis method based on dilution series for evaluating the quality of each step in the cell count measurement process of specific cell preparations using quality indicators. These quality indicators are evaluated based on the repeatability of the measurement and the degree of conformity of the measurement results with the ideal dilution fraction response model. This document is applicable to total cell count, sorted cell count, and direct and indirect cell count measurement processes, provided that the measurement process meets the experimental design standards (e.g., the cells must be suspended in a solution). This document is most suitable for the development, optimization, validation, and/or confirmation of cell count measurement processes. This document is particularly suitable for situations where there are no appropriate standard materials/standard samples to evaluate accuracy. This method does not directly provide the accuracy of cell count. This document is primarily applicable to eukaryotic cells. Note: Cell count is already included in several international and national standards for specific industries/applications. Therefore, it is very helpful to refer to existing standards within the applicable scope when operating.