Livrables Documents, reports (6) initial clinical specificity and and sensitivity data Prepare summary report of initial clinical sensitivity and specificity Process and Product Risk Analysis Report Prepare report on robustness of manufacturing process and assay set up. certain proprietory formulation and manufacturing process data to be kept confidential. Analytical specificity data Analytical specificity data produced. Use potential cross reactive respiratory virus samples. Clinical Validation Plan Finalise clinical validation plan with Medcaptain and IRCCS Interim Activity report Interim Activity Report to summarise activity by the consortia Clinical Validation Report Prepare report on diagnostic assay performance based on information to be included in the product Instructions for Use. Websites, patent fillings, videos etc. (1) Project Website Prepare website for disclosure of relevant project data and progress and/or arrange protocol for filing of public data with public repository of COVID 19 as recommended by EU. Demonstrators, pilots, prototypes (1) Validation Batches Manufacture batches of diagnostic kits for validation Recherche de données OpenAIRE... Une erreur s’est produite lors de la recherche de données OpenAIRE Aucun résultat disponible
