Description du projet
Maîtriser la COVID-19 grâce à des tests rapides
Le testing est une pierre angulaire essentielle de la réponse à la COVID-19. Des tests moléculaires ont été mis en place dans le mois qui a suivi le séquençage du virus, mais ils sont effectués en laboratoire. Des tests rapides sont nécessaires pour détecter la présence du virus quelque part. Ces tests rapides sont également plus rapides et moins chers. Ils sont donc essentiels pour maîtriser et combattre la COVID-19. Dans ce contexte, le projet KRONO, financé par l’UE, développe un essai lyophilisé pour la détection directe du coronavirus à partir d’échantillons d’écouvillons nasaux. Ce test peut être effectué n’importe où. Le projet testera son essai lyophilisé. La recherche documentera les normes quantifiées et les données d’évaluation des performances dans le cadre de sa norme de qualité ISO13485 et produira des données pour l’homologation d’urgence «Emergency Use Authorisation».
Objectif
This project focuses on rapid (40min), simple, Point-of-Need COVID-19 testing, e.g. surgery/home (via first responders)/transit points of entry. BG Research (BGR) has developed direct from crude sample detection of viral pathogens – the QuRapID-XF technology, removing requirement for nucleic acid extraction, expert users or a laboratory; results delivered while you wait. Tests utilise the Gold Standard polymerase chain technology as current clinical reference tests, but using our novel reagent, directly breaking open the virus and a single enzyme system that is resistant to the inhibitory compounds found in crude biological samples.
Objectives:
1. Develop a lyophilised assay for direct detection of SARS-CoV-2 from nasal swab samples.
1. Production scaling of a portable instrument for performing the test at Point-of-Need.
2. Demonstration of a pipeline for rapidly deploying new assays in response to future outbreaks and detection from a wider range of sample types.
3. Validation of the assay at 3 independent sites using clinical samples, generating data sets for regulatory approval.
Achieving the objectives:
BGR has pre-production portable systems in testing for the in-field detection of veterinary diseases from animal nasal swabs. This project will bring scaled production of the product forward by minimally 3 months together with a validated lyophilised SARS-CoV-2 assay. The team has proven experience in diagnostics design and development and will have access to clinical patient samples from Italy and France, generating quantified standards and performance evaluation data that BG Research will document under its ISO13485 quality standard and generate data for EUA regulatory approval.
Relevance to Work P:
The IMI2 call is seeking innovative diagnostics to have impact in combating the current Coronavirus outbreak and this proposal to provide rapid and simplified differential diagnostics at the point of need, is directly aligned with the scope.
Champ scientifique
- natural sciencesbiological sciencesbiochemistrybiomoleculesnucleic acids
- medical and health sciencesclinical medicinesurgery
- natural sciencesbiological sciencesmicrobiologyvirology
- medical and health scienceshealth sciencesinfectious diseasesRNA virusescoronaviruses
- natural sciencesbiological sciencesbiochemistrybiomoleculesproteinsenzymes
Mots‑clés
Programme(s)
Thème(s)
Régime de financement
RIA - Research and Innovation actionCoordinateur
13284 Marseille
France