Verification of IVD method for rapid antibiotic susceptibility testing (AST)
| Reference number | |
| Coordinator | GRADIENTECH AB |
| Funding from Vinnova | SEK 1 224 125 |
| Project duration | September 2016 - August 2017 |
| Status | Completed |
Purpose and goal
The aim of the project has been to bring Gradientech´s IVD system for ultra-rapid AST closer to CE-IVD certification, partly by the evaluation and contracting of design- and manufacturing partners of the consumable of the system, partly by completing a verification study with clinical bacteria isolates together with the EUCAST reference lab. By today, all design- and manufacturing partners are contracted and the collaboration works excellent. The verification results indicate very high agreement of the AST-results from our IVD-prototype system and the reference method.
Expected results and effects
The results from the project show that our IVD-system for ultra-rapid AST has high (>95%) essential agreement with the reference method for AST for the currently tested strains and antibiotics. This strongly indicates that the system can be CE-IVD certified and become the fastest system on the market for AST of bacteria from blood culture. This result gives the overall design-project lower risks, which is of highest importance for existing and potential investors.
Planned approach and implementation
The project has been realized as planned. Much more time than initially planned has been needed for software bug fixes and hardware adjustments in the instrument prototype, as well as for algorithm optimisation and modifications. The collaboration between us two project partners has worked excellent and will continue with high value for the IVD-system´s coming verification and validation activities.