ISO 20391-2:2019

Biotechnology — Cell counting — Part 2: Experimental design and statistical analysis to quantify counting method performance

Scope

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.