Microbiology of food and animal feeding stuffs. Polymerase chain reaction (PCR) for the detection and quantification of food-borne pathogens. Performance characteristics (ISO 22118:2011)
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ISO 22118:2010 specifies minimum requirements of performance characteristics for the detection of nucleic acid sequences (DNA or RNA) by molecular methods. ISO 22118:2010 applies to the detection of food-borne pathogens in foodstuffs and isolates obtained from them using molecular detection methods based on the polymerase chain reaction (PCR). ISO 22118:2010 is also applicable, for example, to the detection of food-borne pathogens in environmental samples and in animal feeding stuffs.
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Sisällysluettelo
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Performance characteristics of qualitative and quantitative detection methods
4.1 General
4.2 Scope of the method
4.3 Scientific basis
4.4 Selectivity
4.5 Sensitivity
4.6 Robustness
4.7 Analytical controls
4.8 Trueness and precision
4.9 Instruments
5 Performance characteristics for validation
5.1 General
5.2 Determination of the limit of detection, limit of quantification, and range of use for molecular detection methods
6 Validation report
6.1 General
6.2 Qualitative methods
6.3 Quantitative methods
Annex A Minimum list of microorganisms for use in the exclusivity tests for detection bacteria (informative)
ISO 16140:2003 Microbiology of food and animal feeding stuffs -- Protocol for the validation of alternative methods
ISO 22174:2005 Microbiology of food and animal feeding stuffs -- Polymerase chain reaction (PCR) for the detection of food-borne pathogens -- General requirements and definitions
ISO 16140:2003 Microbiology of food and animal feeding stuffs -- Protocol for the validation of alternative methods
ISO 22174:2005 Microbiology of food and animal feeding stuffs -- Polymerase chain reaction (PCR) for the detection of food-borne pathogens -- General requirements and definitions