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Pilot line for paper based electrochemical test strips dedicated to quantitative biosensing in liquids

Periodic Reporting for period 3 - IMPETUS (Pilot line for paper based electrochemical test strips dedicated to quantitative biosensing in liquids)

Reporting period: 2020-10-01 to 2022-10-31

Is treatment with antibiotics effective? Distinguishing between bacterial and viral infection quickly and cost-effectively was just one application example for the fabrication processes for paper-based biosensors developed in the IMPETUS project. The project aimed to combine paper, printing and microchip technologies to implement a pilot line manufacturing facility in an industrial environment. The pilot line, which was set up at IMPETUS partner tagtron GmbH in Vöcklabruck, will be used to produce fully integrated paper-based electrochemical biosensors that can transfer test results directly to a smartphone. Most infectious diseases require coordinated treatment, which can only take place if medical professionals can also identify the infection. Laboratory tests are time-consuming, cost-intensive and often take too long. This is where the project came in and developed the basis for quickly and cost-effectively implementing tests tailored to individual diseases. The novel paper-based diagnostic test card concept will allow quantitative measurement of biomolecules in blood by healthcare professionals in the field. The new detection method combines paper, printing, and microchip technologies and closes the gap between various rapid tests and complex laboratory analyses. However, the decisive factor for the breakthrough is above all that the diagnostic method not only delivers fast and accurate results, but is also simple to use and cost-effective.
The IMPETUS project involved renowned partners with a strong focus on industrialisation: Four research institutes: AIT Austrian Institute of Technology GmbH, Silicon Austria Labs GmbH, Papiertechnische Stiftung, Chemnitz University of Technology - five SMEs: Maurer Services GmbH, Maurer Engineering UG, Pro-Active sprl, Saralon GmbH, tagtron GmbH - five large companies: Felix Schoeller Holding GmbH & Co KG, Infineon Technologies Austria AG, R-Biopharm AG, Ricoh UK Products Ltd, Sun Chemical Ltd.
The pilot line production facility, which is to enable the mass production of the biosensor with all its individual components, was realized at tagtron. Suitable screen, flexo and inkjet printing processes have been developed for this purpose, as well as a novel method of chip mounting for roll-to-roll production. In addition, a special paper that meets the diverse requirements of the diagnostic test card concept was developed and its fabrication upscaled to an industrial manufacturing process. For a test, a few drops of the body fluid to be tested are applied to the test card. After a completely autonomous measurement process to determine the concentration of the biomolecules relevant for the respective diagnostic question, the measurement data is transferred from the test card to the smartphone. The disposable tests have the size of a credit card. The developed energy-efficient silicon microchip provides electrochemical signal acquisition, storage and contactless NFC data transmission. A printed battery is all that is needed to supply power here. The entire system is designed to be as sustainable as possible; the packaging and other parts can be made of sustainable materials, and plastic is replaced by paper. The cost of a single test, after the pilot phase, is planned to be less than 20 euros.
The exploitation strategy developed in the project included a biosensing business plan and a pilot line business plan. Moreover, a Memorandum of Understanding (MoU) to ensure activities after the project end was prepared and signed by the project partners. Three patents covering the innovations of the chip mounting concept (granted), the microchip (granted) and the biosensor electrode configuration (filed) were prepared. The major dissemination activities were publications, presentations at scientific and technical events, as well as the promotion of the project in the form of exhibition booths. All peer-reviewed publications were published open-access.
Main progress achieved beyond the state of the art:
- Pilot line capable of manufacturing paper-based electronics dedicated to quantitative electrochemical biosensing devices for point-of-care applications combining flexo-, screen- and inkjet-printing.
- Realisation of an in-line chip roll-to-roll chip mounting module, which is integrated on the pilot line.
- Paper developed with suitable characteristics required for the integration of the electrodes, microchip, and electrochemical biosensor.
- Realisation of a highly integrated and energy-efficient microchip enabling biosensor measurements, with data acquisition, storage secure NFC transmission.
- Realisation of a printed electrochemical LFD for quantitative measurement of two biomolecule concentrations in blood allowing the differentiation of bacterial from viral infections.
- Realisation of a paper-based test card demonstrator (standard credit card size) integrating the developed components electrochemical LFD, printed antenna, microchip and printed battery for the quantitative detection of biomolecules in serum samples.

Potential impact:
- Pilot line with a versatile manufacturing concept easy to be adapted for various sensing applications.
- The showcase application for the biosensing system is the distinction between viral and bacterial infections to avoid false medication of viral infections by antibiotics.
- By providing inexpensive and fast quantitative readout of application-specific biomarkers, the IMPETUS biosensing system has the potential to open up molecular testing in a wide range of point-of-need applications.
IMPETUS mock-up biosensing test card
IMPETUS pilot line
Showcase application of IMPETUS biosensing system for distinction of viral and bacterial infection