FORTIFIEDx
The FORTIFIEDx project aims to revolutionize the field of point-of-care in vitro diagnostics (POC IVD) by developing novel multifunctional biocompatible photopolymers. These can be (micro-)structured using roll-to-roll nanoimprint lithography to develop for the first time a true sample-to-result POC test, which enables sampling and evaluation on the same microfluidic patch.
Project partners
- Polymer Competence Center Leoben (PCCL)
- KU Leuven (KUL), Coordinator
- Joanneum Research (JR)
- Montanuniversität Leoben (MUL)
- Institute of Tropical Medicine Antwerp (ITM)
- Tyndall National Institute (TYN)
- Zdalny Serwis sp (ZDS)
- Temicon (TEM)
- Center National de Formation et de Recherche en Santé Rurale de Maferinyah (CNFRSR)
Motivation and goals
In vitro diagnostic (IVD) technologies have transformed healthcare, but are still reliant on laboratories. The COVID-19 pandemic showed that a centralized approach is not enough to effectively combat virus outbreaks. Therefore, there is an urgent need to make laboratory-quality diagnostics available directly at the point-of-care (POC).
The FORTIFIEDx consortium develops a microfluidic POC patch that is able to (self-)collect biofluids via hollow microneedles (HMN) and analyzes these samples on the same patch immediately and completely self-sufficiently, without the need for medical expertise or a laboratory. This enables quick and easy diagnosis anywhere in the world.
Two emerging clinical needs that pose an epidemic/pandemic threat in both developed and developing countries were selected for the design of the FORTIFIEDx patch:
- Sexually transmitted diseases (STDs): The simultaneous diagnosis of HIV and syphilis enables a timely diagnosis of patients who are unable to reach central facilities due to stigmatization or financial difficulties.
Viral Haemorrhagic Fevers (VHF): The detection of Ebola and Lassa viruses enables to combat their highly contagious and deadly outbreaks.
The FORTIFIEDx value chain covers all the aspects from investigation of multifunctional materials to their exploitation for unmet clinical needs with the aim to deliver a disposable and self-powered microfluidic-based IVD POC test.
To achieve this ambitious goal, the interdisciplinary and experienced FORTIFIEDx consortium (2 universities, 5 research institutes and 2 SMEs from 6 countries) combines knowledge from the fields of materials science, engineering and microfabrication, microfluidic technology development, bioassay development, clinical validation and life cycle assessment.
Main Goals
1. Development of a microfluidic module by:
- Investigating the use of novel photocurable vitrimers and their multifunctionality,
- Novel roll-to-roll process for the mass production of multifunctional microfluidic patches and
- Development of various microfluidic (i)SIMPLE modules to support different steps of liquid processing on the chip.
2. Development of a new sampling module by:
- Investigating innovative microfabrication approaches to create out-of-plane HMN arrays that can be integrated with the (i)SIMPLE to create a painless sampling module,
- Utilization of reactive ink jet printing of mechanical substrates and gradient materials for the transition from “soft to rigid”,
Validation of the sampling module as a key unit to eliminate all manual steps in sampling.
3. Development of a bioassay module by:
- Developing bioassays for the simultaneous on-chip detection of HIV and syphilis (immunologically based bioassay),
- Developing bioassays for the on-chip detection of Ebola and Lassa viruses (molecular-based bioassay).
4. Validation:
- Conduct an analytical and clinical validation of the established FORTIFIEDx patch,
- Conduct a study to evaluate the life cycle of the FORTIFIEDx patch and its use in decentralized clinical settings.
Objectives and Approach
The FORTIFIEDx consortium aims to revolutionize the IVD field and in particular the field of POC testing by using novel multifunctional biomaterials and their structuring to develop a true sample-to-result test for the first time. To achieve this, a FORTIFIEDx patch is developed that enables both, the (self-)collection of biofluids using HMN and the immediate analysis of this sample on the same patch.
To achieve its goals and create broad acceptance of point-of-care in vitro diagnostics, FORTIFIEDx combines knowledge from the fields of materials science, engineering and microfabrication, microfluidic technology development, bioassay development, clinical validation and life cycle assessment in its interdisciplinary consortium (2 universities, 5 research institutes and 2 SMEs from 6 countries). The project is coordinated by KU Leuven.
“The FORTIFIEDx consortium is highly interdisciplinary and brings together many experts along the value chain of point-of-care in-vitro diagnostics. The topic is highly relevant to society, as decentralized diagnostics will become increasingly important in the future. The PCCL is contributing to the development of multifunctional photopolymers that can be structured using nanoimprint lithography and thus serve as the core material for the microfluidic patch.”
Downloads & Links
Funding Body
Funded by the European Union (grant agreement Nº 101092049). Views and opinions expressed are however those of the author(s) only and do not necessarily reflect those of the European Union or the granting authority European Union’s Horizon Europe research and innovation programme. Neither the European Union nor the granting authority can be held responsible for them.
