Validation of novel immunoassays according to European legislation for the rapid analysis of ochratoxin A in cereal, grape, and dried vine fruit samples

Harmonizing analytical criteria for the validation of rapid methods is fundamental in contemporary food safety analysis. Immunoassays have achieved notable success in mycotoxin detection, particularly due to their suitability for low-resource laboratories and on-site applications. In the present stu...

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Detalles Bibliográficos
Autores: Cantero Gómez, Mario, López-Puertollano, David, Navarro-Fuertes, I., Abad Somovilla, Antonio, Salcedo Domínguez, Jaime, González-Candelas, Luis, Ballester Frutos, Ana Rosa, Abad Fuentes, Antonio, Mercader Badia, Josep Vicent
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2025
País:España
Institución:Consejo Superior de Investigaciones Científicas (CSIC)
Repositorio:DIGITAL.CSIC. Repositorio Institucional del CSIC
OAI Identifier:oai:digital.csic.es:10261/407851
Acceso en línea:http://hdl.handle.net/10261/407851
https://api.elsevier.com/content/abstract/scopus_id/105022603313
Access Level:acceso abierto
Palabra clave:ELISA
EU legislation
LFIA
Mycotoxin
OTA
Raisins
mycotoxins
raisins
Descripción
Sumario:Harmonizing analytical criteria for the validation of rapid methods is fundamental in contemporary food safety analysis. Immunoassays have achieved notable success in mycotoxin detection, particularly due to their suitability for low-resource laboratories and on-site applications. In the present study, two novel monoclonal antibody-based immunoassays were in-house developed and validated for the analysis of ochratoxin A, in line with the latest European regulations. The performance of both methodologies was evaluated using five different cereal grains, two types of grape matrices, and two types of dried vine fruits. Recovery rates and repeatability of the enzyme-based immunoassay meet the European Commission's criteria for confirmatory methods. Concerning the lateral flow immunoassay, the screening target concentration was aligned with the European maximum permitted levels of ochratoxin A for each food product. The calculated false suspect rates for blank samples were at or below 1 %, with a certainty of 95 %, consistent with the requirements by the European Commission for semi-quantitative screening methods. The accuracy of both immunoanalytical approaches was confirmed through the analysis of certified reference materials. Finally, a market survey of dried vine fruits revealed one sample exceeding the European legal limit for ochratoxin A, demonstrating the applicability of the methods.