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Evaluation of a production ready portable, Point-of-Need Platform (instrument and reagents), direct from nasal swab test for the molecular diagnostic detection of COVID-19 infection.

Project description

DEENESFRITPL

Containing COVID-19 with rapid tests

Testing is a critical cornerstone of the COVID-19 response. While molecular tests were rolled out within a month of the virus being sequenced, these are laboratory based. Rapid tests are necessary to detect the presence of the virus anywhere. These rapid tests are also faster and cheaper. As such, these tests are vital to contain and fight COVID-19. With this in mind, the EU-funded KRONO project is developing a lyophilised assay for direct detection of the coronavirus from nasal swab samples. This test can be conducted anywhere. The project will test its lyophilised assay. Research will document quantified standards and performance evaluation data under its ISO13485 quality standard and generate data for Emergency Use Authorisation regulatory approval.

Objective

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.

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Topic(s)

Call for proposal

H2020-JTI-IMI2-2020-21-single-stage

See other projects for this call

Funding Scheme

RIA - Research and Innovation action

Coordinator

UNIVERSITE D'AIX MARSEILLE
Net EU contribution
€ 321 750,00
Address
Boulevard charles livon 58 le pharo
13284 Marseille
France

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Region
Provence-Alpes-Côte d’Azur Provence-Alpes-Côte d’Azur Bouches-du-Rhône
Activity type
Higher or Secondary Education Establishments
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Other funding
€ 0,00

Participants (4)

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Last update: 13 May 2023

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Permalink: https://cordis.europa.eu/project/id/101005075

European Union, 2023