Our approach
Despite the fact that IVD technologies have revolutionized healthcare, they remain confined to the laboratory environment.
Traditional centralized healthcare approach
This practice does not fulfil current expectations on how to manage and treat diseases, thereby resulting in the growing pressure to move towards a decentralized approach.
Decentralized strategy
Decentralized strategy is expected to bring time and cost benefit for the patients, doctors and the healthcare system in general. Therefore, over the past decade, we have witnessed continuous efforts to bring lab-quality bioassays from the lab to the POC (i.e. to the hands of end users in clinics, homes and remote communities). In this context, lab-on-a-chip (LoC) technologies have long promised to accomplish this based on their capacity to miniaturize and automate bioassays at a low(er) cost. Nevertheless, despite many attempts, LoC technologies have so far failed to make a significant impact and reach the market.
Traditional rapid diagnostic tests
While some rapid diagnostic tests (RDTs) have reached the market, all of them still require manual off-chip pre-processing of sample (e.g. metering or dilution), limiting their use by non-experienced operator and therefore the implementation at the POC.
Our approach
FORTIFIEDx consortium aims to revolutionize the IVD field and in particular the field of POC testing by making use of novel multifunctional biomaterials and their structuring with mass fabrication technology to develop for the first time a true sample-to-result test. To achieve this, we will develop a FORTIFIEDx patch capable of both biofluids (self-)sampling via HMN and immediate analysis of this sample on the very same patch. To accomplish this, we will work on the development of:
Microfluidic module
By:
- Studying the use of novel photocurable vitrimers and their multifunctional nature,
- Novel roll-to-roll process for the mass fabrication of multifunctional microfluidic chips and
- Developing different microfluidic (i)SIMPLE modules, to support various on-chip liquid handling steps.
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- Novel roll-to-roll process for the mass fabrication of multifunctional microfluidic chips and
- Developing different microfluidic
- (i)SIMPLE modules, to support various on-chip liquid handling steps.
Sampling module
By:
- Studying innovative microfabrication approaches for generating out-of-plane HMN arrays compatible for integrating with the (i)SIMPLE into a painless sampling module,
- Exploiting reactive injecting printing of mechanical support materials and gradient materials for “soft-to-rigid” transition.
- Validating the sampling module as a key unit for removing all manual steps during sample collection.
Bioassay module
By:
- Developing bioassays for simultaneous on-chip detection of HIV and Syphilis (immunological-based bioassay).
- Developing bioassays for on-chip detection of Ebola and Lassa viruses (molecular-based bioassay).
Analytical and clinical validation
By:
- Performing analytical and clinical validation of established FORTIFIEDx patch.
- Conducting a life cycle assessment study on the FORTIFIEDx patch and its use in decentralized clinical settings.
