Objective 1: Develop and optimise two breath-based aerosol sampling methods to detect respiratory pathogens with pandemic potential
During this reporting period, consortium members Avelo and Goethe University Frankfurt (GUF) successfully achieved Objective 1 by completing Work Package (WP) 2. This entailed developing, validating, and operationalising two breath-based aerosol sampling technologies (AveloCollect and AveloMask) together with molecular assays for detection. All activities defined under WP2 were achieved, with the only operational adaptation being the shift from single-batch manufacturing of the AveloMask to staged production and shipment aligned with clinical recruitment timelines. The work under Objective 1 has delivered validated breath aerosol sampling technologies, validated extraction and multiplex virus testing workflows, regulatory-ready manufacturing, and decisive performance data guiding downstream implementation. The consortium is now positioned to advance AveloMask, the most effective XBA sampling solution, into the next clinical phases in full alignment with the project’s scientific, clinical and public-health objectives.
Objective 2: Development of RASC as a benchmark for aerosol detection of respiratory pathogens and comparison of 3 different sampling methods
Ethical approval for the B-Path study was granted by the South African Human Research Ethics Council (HREC) following submission of clarifications regarding pre-specified safety inclusion and exclusion criteria, including thresholds for oxygen saturation, pulse, blood pressure, respiratory rate, and dyspnoea. Approval from the City of Cape Town was subsequently received in October 2025. A total of 80 AveloCollect devices and AveloMasks were received for use in the study.
For downstream analysis, the team agreed to proceed with nucleic acid extraction using the QIAsymphony platform, and finalisation of the analytical workflow is happening based on the data generated from WP2. Recruitment for the clinical study is due to commence in March 2025 to co-incide with the South African respiratory viral season.
Objective 3: Evaluate the diagnostic accuracy of XBA sampling in symptomatic adults, and feasibility of XBA sampling for detecting asymptomatic infection
The project’s clinical studies will be conducted under Objective 3, whereby Project B-Path aims to evaluate the diagnostic accuracy of an exhaled breath aerosol sample in symptomatic adults, and feasibility of sampling for detecting asymptomatic infection. The multisite coordinated study protocol has been developed to be implemented in Bucharest (Romania), Milan (Italy) and Heidelberg (Germany). Ethical approvals have been received, the trial registered in the German Clinical Trial Registry and the studies were registered as the different teams prepared each site for recruitment commencement in March 2026.
Objective 4: Evaluate acceptability, usability, population impact, and cost-effectiveness of XBA sampling for diagnosis and screening of respiratory infections of pandemic potential
Initial work on human factors engineering has been completed with some valuable insights gathered around the mask design, packaging, hygiene, acceptability and consideration for adaptation. A mixed-methods study of 22 participants with both AveloCollect and AveloMask lay the groundwork for evaluating the devices during the remainder of the project. Plans to further assess acceptability, appropriateness and usability are nested within the study protocols under Objective 3 and will take place in Germany, Romania and Italy in adults being diagnosed and screened for respiratory infections.
Population impact and cost-effectiveness of XBA will be analysed in the second half of the project.
