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BS ISO 20391-2:2019 Biotechnology. Cell counting - Experimental design and statistical analysis to quantify counting method performance >
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BS ISO 20391-2:2019 Biotechnology. Cell counting - Experimental design and statistical analysis to quantify counting method performance, 2019
- National foreword
- Foreword
- Introduction
- 1 Scope
- 2 Normative references
- 3 Terms, definitions, symbols and abbreviated terms
- 3.1 Terms and definitions
- 3.2 List of abbreviated terms and symbols
- 4 Principle
- 4.1 General
- 4.2 Proportionality
- 4.3 Deviation from proportionality
- 5 Experimental design
- 5.1 General
- 5.2 Considerations for the cell counting measurement process
- 5.3 Preparation of samples for the experimental design
- 5.3.1 General
- 5.3.2 Stock cell solution
- 5.3.3 Dilution fraction experimental design
- 5.3.4 Considerations for generating dilution fractions
- 5.4 Test sample labelling
- 5.5 Measurement of the test sample
- 6 Statistical methods
- 6.1 General
- 6.2 Mean cell count
- 6.3 Measurement precision
- 6.4 Proportional model fit
- 6.5 Coefficient of determination
- 6.6 Proportionality index (PI)
- 6.6.1 General
- 6.6.2 Calculation of the smoothed residual (esmoothed)
- 6.6.3 Calculation of proportionality index (PI)
- 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
- 6.8.4 Interpretation of PI values
- 6.8.5 Comparison of PI values
- 7 Reporting
- 7.1 Reporting of quality indicators
- 7.2 Documentation of experimental design parameters and statistical analysis method
- 7.3 Additional reporting elements on the cell counting measurement process
- Annex A (informative) Method to assess pipetting error contributions to dilution integrity
- Annex B (normative) Method to calculate smoothed residual (esmoothed) when a set of measured dilution fractions (DFmeasured) is obtained
- Annex C (informative) Example formulae for calculating PI
- Annex D (informative) Use case 1 — Evaluating the quality of a single cell counting measurement process
- Annex E (informative) Use case 2 — Comparing the quality of several cell counting measurement processes
- Bibliography [Go to Page]