Evaluating the quality of a cell counting measurement process via a dilution series experimental design

Published

August 14, 2017

Author(s)

Sumona Sarkar, Steven Lund, Ravi Vyzasatya, Padmavathy Vanguri, John Elliott, Anne Plant, Sheng Lin-Gibson

Abstract

Cell counting measurements (methods to determine cell quantity) are critical in the research, development, and manufacturing of cell-based products and support decision making in product testing and release. Determining cell quantity with accuracy and precision remains a challenge, with few resources available for validating and evaluating a cell counting measurement process. This work describes an experimental design combined with a statistical analysis approach to evaluate the quality of a cell counting measurement process in the absence of an appropriate reference material or reference method. The experimental design is based on a dilution series study with replicate samples and process controls. The statistical analysis methods evaluate the precision, accuracy (in terms of deviation from proportionality), and comparability for cell counting methods via coefficient of variation (CV), a summary statistic for proportionality, and comparative bias, respectively. The experimental design and statistical analysis were applied for the counting of a human mesenchymal stem cell (hMSC) preparations using an automated fluorescent image based counting device (ACD) and manual counting chambers (MCCs). For the hMSC preparation investigated, results suggest that the ACD counting method performed better than the MCC counting methods both in terms of quality of the measurements (with respect to precision and proportionality) and analysis time.

Citation

Cytotherapy

Pub Type

Journals

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Keywords

cell therapy, cell counting, regenerative medicine, experimental design

Citation

Sarkar, S. , Lund, S. , Vyzasatya, R. , Vanguri, P. , Elliott, J. , Plant, A. and Lin-Gibson, S. (2017), Evaluating the quality of a cell counting measurement process via a dilution series experimental design, Cytotherapy, [online], https://tsapps.nist.gov/publication/get_pdf.cfm?pub_id=921053 (Accessed November 14, 2025)