Descrizione del progetto
Contenere la Covid-19 attraverso test rapidi
I test rappresentano un caposaldo cruciale della risposta alla Covid-19. I test molecolari, sebbene siano stati introdotti a meno di un mese dal sequenziamento del virus, si svolgono in laboratorio. Sono necessari test rapidi per individuare la presenza del virus ovunque. Questi test rapidi sono inoltre più veloci ed economici: di conseguenza, sono essenziali per contenere e lottare contro la Covid-19. In quest’ottica, il progetto KRONO, finanziato dall’UE, sta sviluppando un test liofilizzato, che può essere condotto ovunque, per l’individuazione diretta del coronavirus attraverso campioni di tampone nasale. Il progetto verificherà il proprio test liofilizzato. La ricerca documenterà standard quantificati e dati di valutazione delle prestazioni attraverso il proprio standard di qualità ISO13485 e genererà dati per l’approvazione normativa dell’autorizzazione all’uso di emergenza.
Obiettivo
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.
Campo scientifico
- natural sciencesbiological sciencesbiochemistrybiomoleculesnucleic acids
- medical and health sciencesclinical medicinesurgery
- natural sciencesbiological sciencesmicrobiologyvirology
- medical and health scienceshealth sciencesinfectious diseasesRNA virusescoronaviruses
- natural sciencesbiological sciencesbiochemistrybiomoleculesproteinsenzymes
Parole chiave
Programma(i)
Argomento(i)
Invito a presentare proposte
H2020-JTI-IMI2-2020-21-single-stage
Vedi altri progetti per questo bandoMeccanismo di finanziamento
RIA - Research and Innovation actionCoordinatore
13284 Marseille
Francia