Title: Fuzzy-logic based strategy for validation of multiplex methods: example with qualitative GMO assays
Citation: TRANSGENIC RESEARCH vol. 19 no. 1 p. 57-65
Publisher: SPRINGER
Publication Year: 2010
JRC N°: JRC47309
ISSN: 0962-8819
URI: http://publications.jrc.ec.europa.eu/repository/handle/JRC47309
DOI: 10.1007/s11248-009-9293-9
Type: Articles in periodicals and books
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 of 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.
JRC Directorate:Institute for Health and Consumer Protection Historical Collection

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