Diagnosis methods and European regulation
There are different methods available for sIgE determinations of single allergenic components. These components might be available as individual diagnostics or multiplexed in arrays. These technologies are commercialized by Thermo Fisher, MADx, Hycor, Euroline and Siemens. The list of available allergens in each platform has recently been described in detail20 . Most of the existing methods for CRD (Component-resolved diagnosis) and multiplexed platforms, have been commercialized for research purposes and will need an adaptation and upgrade to comply with new regulatory EU framework as required by the regulation affecting in vitro diagnostics and medical devices, with a transition implementation phase ending by 2025 (REGULATION (EU) 2017/746). This regulation implementation will secure the adequate performance of commercialized diagnostics
The best diagnostic strategies − using a combination of clinical evaluation, extract-based diagnosis and CRD − that set the basis for the present document has also been extensively discussed by Matricardi and cols.4