BreathForDx: 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 diagnostics. BreathForDx'Äôs will tackle this problem by establishing exhaled breath aerosol (XBA) as an evidence-based, non-invasive sample for simple detection of respiratory infections that can be undertaken at all levels of care. We will achieve this by developing and optimising two innovative, easy-to-use and scalable XBA sampling devices and generating evidence for their use in diagnosis and screening (for early diagnosis and transmission control). We will use different model pathogens that have caused epidemics and pandemics globally 'Äì SARS-CoV-2, influenza, and tuberculosis (TB) 'Äì and we will generate data on the feasibility of multiplex detection of respiratory pathogens in XBA samples, the adaptability to novel pathogens applying viral metagenomics, and point-of-care testing with lateral-flow assays. We will assess the sampling efficiency of the novel devices against a benchmark Respiratory Aerosol Sampling Chamber and evaluate performance, feasibility, and acceptability, in comparison to the current standard of sampling in multi-country clinical studies of diagnosis and screening. Impact and economic modelling will inform the implementation potential of the novel devices for the different use cases and help assess trade-offs. 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. We envision that a single breath sample enables accessible and accurate detection of highly transmissible respiratory infections, thereby improving both individual and population health.