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