The main objective is to validate the platform developed for the diagnosis of immediate reaction to BLC antibiotics, by the comparison with the available in vivo and in vitro (CE-labelled) assays. In this WP the compliance of relevant essential requirements of the European Directive on ‘In Vitro Diagnostic Medical Devices’ (98/79/EC) will be checked. Results of technical validations done during previous WPs will be input for this WP.
The specific objectives are:
1. Validation of diagnostic performances: sensibility (80 %) and selectivity (98%)
2. Results evaluation compared to other diagnostic assays. Clinical meta-analysis
3. Identification, and assessment of the requirements needed for the potential industrialization of the disc, reagents and optical disc drive
4. Analysis of the compliance with the defined requirements: including qualification of pilot batches, and individual reagents and kit stability evaluation
5. Creation of the technical dossier for evaluating a potential commercialization of the developed COBIOPHAD system