Further Development and Clinical Validation of a Mobile, Non-Invasive Breath Test Device for the Rapid Diagnosis of Tuberculosis as an In-Vitro Diagnostic Device

The project's validation objective is the further development and clinical validation of a portable, non-invasive breath test device for the rapid diagnosis of tuberculosis as an in vitro diagnostic device. The system is based on the detection of specific bacterial markers in exhaled breath using functionalized gold nanoparticles and is to be further developed into a sensitive, cost-effective point-of-care test through the integration of surface-enhanced Raman spectroscopy into a single system. The goal is to transition from an experimental prototype (TRL 3) to a technically and clinically validated system (TRL 5–6) that is ready for regulatory approval and market entry. The project falls within the research fields of infectious disease diagnostics, nanotechnology, and pulmonology.