Reliable analytical methods are a pivotal requirement for the introduction and adoption of reference doses in the European Union and beyond. This activity will report on the suitability of current analytical methods to reliably measure proposed allergens at various concentrations resulting from the use of the Voluntary Incidental Trace Allergen Labelling (VITAL)® 2.0 reference doses. The VITAL® 2.0 reference doses were proposed by the VITAL® scientific expert panel and adopted in late 2011 by the Allergen Bureau of Australia and New Zealand.
The expert group is reviewing the fitness for purpose of current analytical methods to reliably measure the presence of allergens at concentrations resulting from the use of the VITAL® 2.0 reference doses in relevant food matrices. This will include method uncertainty, sensitivity, specificity and reproducibility, for example, challenges resulting from kit and antibody batch consistency (for immunoassays), units of measurement and expression of results. Intra-method reproducibility due to differences in method target specificity should also be considered. Reference will also be made to existing standards for validation of analytical methods for allergen detection and quantification.
This review will identify gaps in existing knowledge and technology, suggest ways to bridge those gaps and identify areas for further research. Apart from the peer-reviewed publication, the conclusions may also serve as a basis to prepare guidance for the analytical community, industry, regulatory stakeholders and patient groups.