NIST Develops Cell Counting Method Evaluation Tool (COMET)
The National Institute of Standards and Technology (NIST) has developed an open-access web-based tool to aid in the implementation of ISO 20391-2:2019: Biotechnology — Cell counting — Part 2. This tool will help organizations more easily conduct the statistical analysis recommended by the standard that could otherwise require additional resources to develop advanced in-house statistical analysis programs.
About the Cell Counting Standard
Cell counting is a fundamental measurement for regenerative medicine that is necessary at every step from basic research to product development, manufacturing, release, and patient monitoring. SCB supported the drafting of a two-part ISO cell counting documentary standard (Part 1, Part 2). The standard guides users in a fit-for-purpose approach to selecting, optimizing, and validating cell counting measurement processes.
Part 2, Experimental Design and Statistical Analysis to Quantify Counting Method Performance, outlines a dilution series experimental design and statistical analysis to calculate a series of quality indicators that stakeholders can use to evaluate the quality of counting measurement processes without the need for cell count reference materials.
About COMET
Some aspects of the statistical analysis and reporting required by ISO 20391-2:2019 can be difficult to implement without advanced statistical tools. To support implementation of the standard and ease the burden on individual entities in developing their own statistical analysis programs, NIST developed an open-access tool for executing the recommended statistical analysis.
The Counting Method Evaluation Tool (COMET) was designed to analyze the performance of cell counting methods based on the ISO 20391-2:2019 dilution series experimental design. COMET:
Can be used to perform the statistical analysis described in the ISO standard
Provides the information needed to meet reporting requirements
Compiles metadata associated with the experiment and provides additional analysis and comparison of methods, as well as count and viability results
For questions on the tool, contact Sumona Sarkar, Ph.D., Biomedical Engineer at NIST, Biosystems and Biomaterials Division.
Learn More with SCB’s Upcoming Standard Implementation Course
This web-based tool, together with an upcoming SCB course on the ISO 20391 Cell Counting Standard Series, will help improve understanding and implementation of these standards, leading to higher-quality count-based measurements, which are critical in the characterization and testing of regenerative medicine products.
For updates on the upcoming SCB cell counting implementation course, please contact Katie Zander, Ph.D., SCB Technical Program Manager.