Abstract
This paper illustrates the advantages that a fuzzy-based aggregation method could bring into the validation of a multiplex method for GMO detection (DualChip® GMO kit, Eppendorf). Guidelines for validation of chemical, bio-chemical, pharmaceutical and genetic methods have been developed and ad hoc validation statistics are available and routinely used, for in-house and inter-laboratory testing, and decision-making. Fuzzy logic allows summarising the information obtained by independent validation statistics into one synthetic indicator of overall method performance. The microarray technology, introduced for simultaneous identification of multiple GMOs, poses specific validation issues (patterns of performance for a variety of GMOs at different concentrations). A fuzzy-based indicator for overall evaluation is illustrated in this paper, and applied to validation data for different genetically modified elements. Remarks were drawn on the analytical results. The fuzzy-logic based rules were shown to be applicable to improve interpretation of results and facilitate overall evaluation of the multiplex method.
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Acknowledgments
This study was financially supported by the European Commission through the Integrated Project “Co-Extra”, contract 007158, under the 6th Framework Programme, priority 5, food quality and safety. This support is gratefully acknowledged. Thanks also to Laura Bonfini, Hermann Broll, Marco Mazzara, and Maddalena Querci (European Commission Joint Research Centre, Institute for Health and Consumer Protection, Ispra, Italy) for constructive criticism and suggestions.
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Bellocchi, G., Bertholet, V., Hamels, S. et al. Fuzzy-logic based strategy for validation of multiplex methods: example with qualitative GMO assays. Transgenic Res 19, 57–65 (2010). https://doi.org/10.1007/s11248-009-9293-9
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DOI: https://doi.org/10.1007/s11248-009-9293-9