about us

concept

the concept

breath for dx
concept

Respiratory pathogens are a leading cause of morbidity and mortality, both in the EU and globally and will continue to threaten health security through future epidemics and pandemics. The current COVID-19 pandemic has clearly demonstrated that diagnostics are key for surveillance and screening to drive public health interventions and countermeasures that limit transmission.

Clinical presentations of respiratory infections overlap; thus, rapid diagnostics are necessary to identify the causative pathogen and drive appropriate measures and treatment, especially considering that respiratory infection syndromes also cause the most AMR-related deaths globally.

Current state

Capturing and isolating pathogens from exhaled breath aerosol (XBA) typically requires large, non-scalable sampling chambers. Small studies indicate that facemask sampling (FMS) coupled with molecular pathogen detection is promising, but FMS requires wearing for 30 minutes, which many find challenging. No portable, efficient XBA sampler meeting these needs has been commercialized or clinically validated.

Project Ambition

Our project aims to advance XBA sampling beyond current methods by optimizing a simplified, fast, and scalable device called AveloCollect. This device uses a fiber mat and an aerodynamic flow channel to efficiently collect and dissolve XBA, enhancing pathogen recovery and compatibility with existing diagnostic workflows. The project will further develop AveloCollect from technology readiness level (TRL) 3 to TRL 5, validate it in clinical studies, and achieve CE-IVD marking.

State-of-the-Art

FMS has shown 86% sensitivity in capturing and detecting Mtb compared to sputum, with potential for earlier detection. However, variations in bacillary concentration and reference system sensitivity pose challenges. The Respiratory Aerosol Sampling Chamber (RASC) system, which uses fluorescence imaging for single viable Mtb bacilli detection, has demonstrated over 90% sensitivity.

Project Evaluation

The project will benchmark AveloCollect and FMS against the RASC system. A clinical study in South Africa will recruit patients with confirmed pulmonary TB to compare the performance of these devices in diagnosing TB. This will establish data on detection limits and improve understanding of Mtb transmission detection.

Diagnostic Accuracy

No published studies have evaluated XBA sampling methods with WHO-recommended molecular diagnostics for Mtb. The project will conduct diagnostic accuracy studies for AveloCollect and FMS in Romania, comparing them against mycobacterial sputum culture and WHO-recommended TB molecular diagnostics. This will also assess the ability to detect TB drug resistance mutations.

Screening in Migrants

The project will assess the feasibility of XBA-based molecular testing for TB and respiratory viruses in migrants in Italy and Germany. The study will evaluate the acceptability, usability, and appropriateness of the devices for screening symptomatic and asymptomatic individuals.

Implementation Potential

To inform policy adoption, the project will evaluate the cost, cost-effectiveness, affordability, and impact of XBA sampling devices. This comprehensive approach aims to maximize the project’s impact on policy, market, and society, advancing XBA as a novel, validated, non-invasive method for diagnosing TB and other respiratory infections.