DIANA enables simple and reliable on-site diagnostics

Point-of-Care (PoC) diagnostics aim for decentralized on-site analysis that can be used outside of laboratory infrastructure and can provide a significant time advantage, especially when immediate decisions are required or in the case of (life-saving) measures. Image: Udo Eckert. © Fraunhofer IWU

Application example of lactate measurement for point-of-care performance diagnostics in sports. © Senslab/EKF Diagnostics

Founding of the »DIANA Point-of-Care Technology Central Germany e.V.« on 14.12.2024. From left to right: Dr. Christopher Pöhlmann (SensLab GmbH), Udo Eckert (Fraunhofer IWU), Eric Gärtner (Fraunhofer IWU), Lars Georgi (VEMASinnovativ), Dr. Dirk Kuhlmeier (Fraunhofer IZI), Nina Oswald (Fraunhofer IZI), Dominique Schubert (SITEC Industrial Technology GmbH), Dr. Robin Schulze (SITEC Industrial Technology GmbH), Prof. Lutz Engisch (HTWK Leipzig), Dr. Andreas Ebert (Wesko GmbH), Dr. Ingolf Lachmann (Roboscreen GmbH). © DIANA e.V.

Simply, cost-effectively, and reliably obtaining and evaluating health status measurement data on-site at the patient's location provides a decisive time advantage in many situations: The WIR! Alliance DIANA has established a network in the region between Leipzig and Chemnitz for the development and manufacturing of innovative Point-of-Care Diagnostics (POCT). This allows individual health data to be collected easily and quickly analyzed in mini-laboratories — sometimes by the patients themselves. The initial focus is on medical applications for humans, but there is also a recognized need for fast and reliable diagnostics in nursing, sports, and veterinary medicine.

WIR! DIANA: a strong alliance with over 80 partners

DIANA stands for DIAgnostics and Sustainability and currently unites around 80 partners, including medium-sized companies, research institutions, and supporters from education and society. Launched as an alliance in 2022, the partners founded the association "DIANA-Point-of-Care Technology Central Germany e.V." last December. The alliance and the association are managed by the Fraunhofer Institutes IWU and IZI, as well as SensLab GmbH. The VEMASinnovativ network is an important partner for the continuous development of DIANA.

More sustainability in medicine; innovative manufacturing technology

Sustainability is not just the namesake for DIANA. The diagnostic solutions to be developed should meet the requirements of a circular economy, meaning used materials should be reusable, reprocessable, or at least recyclable — unlike, for example, COVID-19 rapid tests. This places high demands not only on material selection but also on product design and manufacturing processes, which must allow for later (partial) disassembly. Production technology therefore plays a key role; it must be capable of producing circular-compatible microsystems in large quantities, with the highest precision and at affordable prices. Here, Fraunhofer IWU brings its comprehensive expertise in production technology and microfabrication technologies into play. The team led by Udo Eckert and Eric Gärtner has committed to optimally implementing diagnostic requirements through innovations in manufacturing technology — in collaboration with various manufacturing companies introduced to DIANA via VEMASinnovativ.

Example of blood diagnostics: Project "PlasmaSepPOC"

Biomarkers are substances in the human body that can provide early indications of potential health problems. Two such biomarkers are CRP and lactate. CRP, a protein produced by the liver, increases when the body fights inflammation. A high CRP level in the blood can indicate infections or inflammation and is thus an important indicator. Lactate is a salt of lactic acid, produced in greater amounts during physical exertion or oxygen deficiency. An increase in blood lactate levels can indicate excessive exertion during sports or even medical emergencies.

The PlasmaSepPOC project focuses on separating blood plasma from whole blood samples to detect biomarkers — biomarkers are easily detectable in blood plasma. Current methods for obtaining plasma from whole blood are often time-consuming, expensive, and not suitable for mass production in point-of-care systems. PlasmaSepPOC consolidates expertise from disciplines such as microfluidics, material technology, and diagnostic technology for a future POCT solution. The SensLab team is developing a capillary-force-based method to detect, for example, CRP in blood. This method allows tiny amounts of a specific substance in a sample to be measured. Specialists from Fraunhofer IZI are focusing on designing the microfluidic chips. These chips are tiny, specially designed components that process the blood and perform plasma separation as efficiently as possible. The Fraunhofer IWU evaluates various manufacturing technologies capable of producing very fine filter structures on the order of a few micrometers for this project.