WP 5: Assay validation and Pre-industrial validation

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