Development and validation of rapid molecular diagnostic test for nCoV19

Projektinformationen

HG nCoV19 test

ID Finanzhilfevereinbarung: 101003713

DOI 10.3030/101003713

Projekt abgeschlossen

EK-Unterschriftsdatum 13 Mai 2020

Startdatum 13 Februar 2020

Enddatum 12 August 2021

Finanziert unter

• SOCIETAL CHALLENGES - Health, demographic change and well-being

Gesamtkosten € 931 604,75

EU-Beitrag € 931 604,75

Koordiniert durch

HIBERGENE DIAGNOSTICS LIMITED
Ireland

Leistungen

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