ISO 16140-2:2016
Microbiology of the food chain — Method validation — Part 2: Protocol for the validation of alternative (proprietary) methods against a reference method
ISO 16140-2:2016 specifies the general principle and the technical protocol for the validation of alternative, mostly proprietary, methods for microbiology in the food chain. Validation studies according to ISO 16140-2:2016 are intended to be performed by organizations involved in method validation.
It is applicable to the validation of methods for the analysis (detection or quantification) of microorganisms in
- products intended for human consumption,
- products intended for animal feeding,
- environmental samples in the area of food and feed production, handling, and
- samples from the primary production stage.
It is in particular applicable to bacteria and fungi. Some clauses of ISO 16140-2:2016 could be applicable to other (micro) organisms or their metabolites on a case-by-case-basis. In the future, guidance for other organisms (e.g. viruses and parasites) will be included in ISO 16140:2016 (all parts).
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General principles for the validation of alternative methods
5 Qualitative methods — Technical protocol for validation
5.1 Method comparison study
5.1.1 General considerations
5.1.2 Paired or unpaired study
5.1.3 Sensitivity study
5.1.4 Relative level of detection study
5.1.5 Inclusivity and exclusivity study
5.2 Interlaboratory study
5.2.1 General considerations
5.2.2 Measurement protocol
5.2.3 Calculations and summary of data
5.2.4 Interpretation of data
6 Quantitative methods — Technical protocol for validation
6.1 Method comparison study
6.1.1 General considerations
6.1.2 Relative trueness study
6.1.3 Accuracy profile study
6.1.4 Limit of quantification study
6.1.5 Inclusivity and exclusivity study
6.2 Interlaboratory study
6.2.1 General considerations
6.2.2 Measurement protocol
6.2.3 Calculations, summary, and interpretation of data
Annex A (informative) Classification of sample types and suggested target combinations for validation studies
Annex B (normative) Order of preference for use of naturally and artificially contaminated samples in validation studies
Annex C (informative) General protocols for contamination by mixture and artificial contamination of foods
Annex D (informative) Models for RLOD calculations using data from the method comparison study
Annex E (normative) Points to be considered when selecting strains for testing inclusivity and exclusivity
Annex F (informative) Considerations for calculations of the relative level of detection (RLOD) between laboratories as obtained in an interlaboratory study
Annex G (informative) Principle of the accuracy profile for validation of quantitative models
Annex H (informative) Application of the accuracy profile in the method comparison study
Annex I (informative) Example of the application of the accuracy profile for an interlaboratory study
Bibliography
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General principles for the validation of alternative methods
5 Qualitative methods — Technical protocol for validation
5.1 Method comparison study
5.1.1 General considerations
5.1.2 Paired or unpaired study
5.1.3 Sensitivity study
5.1.4 Relative level of detection study
5.1.5 Inclusivity and exclusivity study
5.2 Interlaboratory study
5.2.1 General considerations
5.2.2 Measurement protocol
5.2.3 Calculations and summary of data
5.2.4 Interpretation of data
6 Quantitative methods — Technical protocol for validation
6.1 Method comparison study
6.1.1 General considerations
6.1.2 Relative trueness study
6.1.3 Accuracy profile study
6.1.4 Limit of quantification study
6.1.5 Inclusivity and exclusivity study
6.2 Interlaboratory study
6.2.1 General considerations
6.2.2 Measurement protocol
6.2.3 Calculations, summary, and interpretation of data
Annex A (informative) Classification of sample types and suggested target combinations for validation studies
Annex B (normative) Order of preference for use of naturally and artificially contaminated samples in validation studies
Annex C (informative) General protocols for contamination by mixture and artificial contamination of foods
Annex D (informative) Models for RLOD calculations using data from the method comparison study
Annex E (normative) Points to be considered when selecting strains for testing inclusivity and exclusivity
Annex F (informative) Considerations for calculations of the relative level of detection (RLOD) between laboratories as obtained in an interlaboratory study
Annex G (informative) Principle of the accuracy profile for validation of quantitative models
Annex H (informative) Application of the accuracy profile in the method comparison study
Annex I (informative) Example of the application of the accuracy profile for an interlaboratory study
Bibliography