BS ISO 20391-2:2019
$198.66
Biotechnology. Cell counting – Experimental design and statistical analysis to quantify counting method performance
| Published By | Publication Date | Number of Pages |
| BSI | 2019 | 62 |
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.
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.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 2 | National foreword |
| 7 | Foreword |
| 8 | Introduction |
| 9 | 1 Scope 2 Normative references 3 Terms, definitions, symbols and abbreviated terms 3.1 Terms and definitions |
| 15 | 3.2 List of abbreviated terms and symbols |
| 16 | 4 Principle 4.1 General |
| 17 | 4.2 Proportionality 4.3 Deviation from proportionality |
| 18 | 5 Experimental design 5.1 General 5.2 Considerations for the cell counting measurement process |
| 19 | 5.3 Preparation of samples for the experimental design 5.3.1 General 5.3.2 Stock cell solution |
| 20 | 5.3.3 Dilution fraction experimental design |
| 21 | 5.3.4 Considerations for generating dilution fractions |
| 22 | 5.4 Test sample labelling 5.5 Measurement of the test sample |
| 23 | 6 Statistical methods 6.1 General |
| 24 | 6.2 Mean cell count 6.3 Measurement precision 6.4 Proportional model fit |
| 25 | 6.5 Coefficient of determination 6.6 Proportionality index (PI) 6.6.1 General |
| 26 | 6.6.2 Calculation of the smoothed residual (esmoothed) 6.6.3 Calculation of proportionality index (PI) |
| 27 | 6.7 Additional statistical analysis and quality metrics 6.8 Data interpretation 6.8.1 General 6.8.2 Interpretation of %CV 6.8.3 Interpretation of R2 |
| 28 | 6.8.4 Interpretation of PI values 6.8.5 Comparison of PI values 7 Reporting 7.1 Reporting of quality indicators |
| 29 | 7.2 Documentation of experimental design parameters and statistical analysis method |
| 30 | 7.3 Additional reporting elements on the cell counting measurement process |
| 31 | Annex A (informative) Method to assess pipetting error contributions to dilution integrity |
| 35 | Annex B (normative) Method to calculate smoothed residual (esmoothed) when a set of measured dilution fractions (DFmeasured) is obtained |
| 37 | Annex C (informative) Example formulae for calculating PI |
| 39 | Annex D (informative) Use case 1 — Evaluating the quality of a single cell counting measurement process |
| 46 | Annex E (informative) Use case 2 — Comparing the quality of several cell counting measurement processes |
| 60 | Bibliography |
