Aspects of systems theory in the analysis and validation of innovative molecular-biological based food pathogen detection methods

Molecular-biological methods for food analysis comprise a detection chain consisting of sample preparation, target purification and detection assays. Given this systemic character systems theory provides basis for discussion of alternative approaches for specification and validation of pathogen detection methods using testing methods derived from other scientific areas. Since the underlying black box mechanism of microbiological methods does not meet the same systemic criteria, microbiological and molecular-biological methods cannot be compared one-to-one in food pathogen detection. This work describes structure and strategy of an alternative approach for analysis and validation to promote broad range implementation of molecular-biological methods in food pathogen detection.