title: Fuzzy-logic based strategy for validation of multiplex methods: example with qualitative GMO assays.
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.
authors.affiliation: European Commission Joint Research Centre, Institute for Health and Consumer Protection, Molecular Biology and Genomics, 21027 Ispra, VA, Italy. giannibellocchi@yahoo.com
authors.forename: Gianni
authors.initials: G
authors.lastname: Bellocchi
authors.forename: Vincent
authors.initials: V
authors.lastname: Bertholet
authors.forename: Sandrine
authors.initials: S
authors.lastname: Hamels
authors.forename: W
authors.initials: W
authors.lastname: Moens
authors.forename: José
authors.initials: J
authors.lastname: Remacle
authors.forename: Guy
authors.initials: G
authors.lastname: Van den Eede
mesh_terms: D000465:Algorithms; D000818:Animals; D003625:Data Collection / Q000379:methods / Q000706:statistics & numerical data; D003627:Data Interpretation, Statistical; D017143:Fuzzy Logic; D005821:Genetic Techniques / Q000706:statistics & numerical data*; D046228:Microarray Analysis / Q000379:methods / Q000706:statistics & numerical data; D030781:Organisms, Genetically Modified / Q000235:genetics*; D054928:Validation Studies as Topic