Validation of screening methods according to Regulation 519/2014/EU. Determination of deoxynivalenol in wheat by lateral flow immunoassay: a case study

Recent advances in evaluation of analytical performances of semi-quantitative immunoassays through single-laboratory validation are presented. Emphasis is given to guidelines set in the Regulation 519/2014/EU that specifies validation criteria for mycotoxin screening methods to be used for official control purposes. A commercial lateral flow immunoassay for deoxynivalenol has been selected as case study and evaluated for its applicability to verify wheat compliance with EC maximum permitted level. The validation design provided information on the precision profile of the method, cut-off, false suspect and false negative rates of samples containing deoxynivalenol above the legal limit. Furthermore, the influence of the co-occurrence of major deoxynivalenol modified forms, i.e. 3-acetyldeoxynivalenol, 15-acetyldeoxynivalenol, and deoxynivalenol-3-glucoside on test results, was evaluated by a factorial design. Finally, the applicability of the validated immunoassay was demonstrated by analysis of a set of 47 naturally contaminated wheat samples, and comparison with results obtained by a LC-MS/MS confirmatory method.

LATTANZIO Veronica;  BIANCAMARIA Ciasca;  POWERS Stephen;  VON HOLST Christoph; 

2017-02-02

ELSEVIER SCI LTD

JRC97426

0165-9936,   

http://dx.doi.org/10.1016/j.trac.2015.10.009,    https://publications.jrc.ec.europa.eu/repository/handle/JRC97426,   

10.1016/j.trac.2015.10.009,