A guided demonstration of the Counting Method Evaluation Tool (COMET) for implementing the ISO 20391-2 Cell Counting standard

Cell counting methods are critical for the development, manufacturing, and release of cellular therapeutic products, where enumeration of total cells, viable cells, and/or defined subpopulations of cells is required as a part of release testing and is relied upon in manufacturing process control. The ISO 20391-2:2019 Cell Counting standard provides an experimental design and statistical analysis approach to quantify and compare counting method performance, supporting method development, selection, and validation. Here we demonstrate an open-source graphical user interface to execute the statistical procedures outlined in ISO 20391-2:2019. Counting Method Evaluation Tool (COMET) is a publicly available user interface that follows the statistical analysis and reporting structure of the ISO standard. The quality metrics of precision (% coefficient of variation), proportionality index, and goodness-of-fit R2 are computed, and convenient plots and tables can be visualized and downloaded using COMET. Additional analyses are available in COMET to evaluate experiment integrity and cell viability results. Here, we demonstrate the utility of COMET in comparing cell counting methods through a series of studies on a nutrient deprived Jurkat cell model system. Using the ISO standard and COMET, we illustrate the evaluation of counting method performance and selection of a fit-for-purpose cell counting method in the model system.

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