Establishing Exhaled Breath Aerosol (XBA) sampling for diagnosis and screening of respiratory infections

Respiratory infections resulted in >7 million deaths in 2020 and were responsible for 7 of the last 9 pandemics, causing trillions of 'Ǩs in economic losses. Despite the importance of early detection for individual health and pandemic control, flawed sampling methods for respiratory infections limit the impact of highly-sensitive molecular diagnostics. BreathForDx'Äôs overall goal is to tackle this problem by establishing exhaled breath aerosol (XBA) as a novel, evidence-based sample for respiratory infections in three use cases: diagnosis, screening, and antimicrobial resistance, using tuberculosis (TB) as a model infection. The project will leverage innovation in bioaerosol and material science, as well as the multidisciplinary (including academia, industry and NGOs) consortium'Äôs track record of delivering transformative diagnostic innovation. More specifically, we will optimise an innovative, easy-to-use, scalable XBA sampling device, and compare it to a face mask sampling device coupled with rapid molecular detection in three clinical studies. We will evaluate the XBA sampling efficiency of these devices using the Respiratory Aerosol Sampling Chamber as a benchmark. Next, we will assess performance of the devices for diagnosis of TB and drug-resistance among symptomatic patients in a high burden EU country. In parallel, we will assess the feasibility of multiplexing XBA samples for multiple respiratory pathogens (i.e., TB, influenza, SARS-CoV-2) in a screening use case. Accuracy and feasibility data will be complemented by data on acceptability and usability, as well as cost-effectiveness and impact modelling to inform the implementation potential of the novel devices across different use cases. We envision a world in which a single breath sample, coupled with point-of-care molecular diagnostics, enables accessible and accurate pathogen and resistance detection of highly transmissible respiratory infections, thereby improving both individual and public health.