Breath aerosol PCR for detection of lower respiratory tract infections: evaluation of a non-invasive face mask collector in pneumonia patients
9 affiliations
- 1Avelo AG, Schlieren, Switzerland
- 2Department of Internal Medicine, University Hospital Basel, Basel, Switzerland
- 3National Center for Disease Control and Public Health of Georgia, Tbilisi, Georgia
- 4Avicenna – Batumi Medical University, Batumi University Hospital (MedCenter), Batumi, Georgia
- 5ZHAW Zurich University of Applied Sciences, School of Life Sciences and Facility Management, ZHAW University of Applied Sciences Institute of Chemistry and Biotechnology, Wädenswil, Switzerland
- 6Avicenna – Batumi Medical University, Batumi, Georgia
- 7Hightechnology Hospital Medcenter, Batumi, Georgia
- 8Department of Internal Medicine, Cantonal Hospital Winterthur, Winterthur, Switzerland
- 9Department of Clinical Research, University of Basel, Basel, Switzerland
Abstract
Etiological diagnosis of lower respiratory tract infections (LRTIs) relies on sputum or bronchoalveolar lavage (BAL), which may be difficult to obtain or invasive. Exhaled breath aerosol (XBA) sampling offers a noninvasive alternative for pathogen detection. We evaluated the performance of the AveloMask, a face mask-based device designed to capture XBAs for molecular testing. In this prospective paired-sample study, hospitalized adults with pneumonia at three hospitals in Switzerland and Georgia provided an XBA sample using the AveloMask and a lower respiratory tract (LRT) specimen (sputum or BAL). XBA samples were analyzed by multiplex PCR using the Roche LightMix® panel, and LRT samples were tested using the BioFire® FilmArray® Pneumonia Panel. Concordance between XBA and LRT samples was assessed using positive percent agreement (PPA), negative percent agreement (NPA), and overall percent agreement (OPA). A total of 93 participants were enrolled, and 63 participants provided paired samples. AveloMask sampling identified the dominant pathogen (lowest Ct value in the LRT sample) in 40/47 LRT-positive cases (85.1%). Across all targets, PPA was 61% (95% CI, 50%–72%), NPA was 99.8% (95% CI, 99%–100%), and OPA was 95% (95% CI, 92%–96%). PPA was higher for bacteria than for viruses, and lower PPA was largely driven by reduced detection of low-abundance or co-infecting pathogens. In an exploratory subset analysis, AveloMask results overlapped with standard-of-care testing and may have informed antimicrobial decision-making. Breath aerosol sampling using the AveloMask enabled noninvasive molecular detection of LRT pathogens in pneumonia cases and may complement conventional standard-of-care testing, particularly when sputum is unavailable.
IMPORTANCE: Pneumonia diagnosis often relies on sputum samples, which many patients cannot provide, or bronchoscopy, which is invasive. This study evaluated a user-friendly face mask that captures exhaled aerosols released during normal breathing and coughing for laboratory testing. In hospitalized patients with pneumonia, the mask identified the most abundant pathogen in most cases and was well tolerated in routine clinical care. These findings show that breath aerosol sampling could provide a practical, noninvasive complement to existing diagnostic methods, especially when sputum is unavailable or difficult to obtain. By making lower respiratory tract (LRT) sampling easier and more accessible, this approach could support faster, more targeted treatment decisions, reduce unnecessary antibiotic use, and expand opportunities for molecular diagnosis in hospitals and other healthcare settings.
This study is registered with ClinicalTrials.gov as NCT06668883.
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BibTeX
@article{tiseo2026breath,
title = {{Breath aerosol PCR for detection of lower respiratory tract infections: evaluation of a non-invasive face mask collector in pneumonia patients}},
author = {Katie Tiseo and Sarah Dräger and Harshitha Santhosh Kumar and Maia Alkhazashvili and Anya Hammann and Patricia Risch and Reto Willi and Tamar Mkhatvari and Christina Fialová and Christian Adlhart and Denise Szabó and Mariam Suknidze and Izolda Pachkoria and Tobias Broger and Elena Ivanova Reipold and Khatuna Varshanidze and Michael Osthoff},
journal = {Journal of Clinical Microbiology},
year = {2026},
month = sep,
doi = {10.1128/jcm.00562-26},
url = {https://doi.org/10.1128/jcm.00562-26},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - Breath aerosol PCR for detection of lower respiratory tract infections: evaluation of a non-invasive face mask collector in pneumonia patients
AU - Katie Tiseo
AU - Sarah Dräger
AU - Harshitha Santhosh Kumar
AU - Maia Alkhazashvili
AU - Anya Hammann
AU - Patricia Risch
AU - Reto Willi
AU - Tamar Mkhatvari
AU - Christina Fialová
AU - Christian Adlhart
AU - Denise Szabó
AU - Mariam Suknidze
AU - Izolda Pachkoria
AU - Tobias Broger
AU - Elena Ivanova Reipold
AU - Khatuna Varshanidze
AU - Michael Osthoff
PY - 2026
DA - 2026/09/10
JO - Journal of Clinical Microbiology
DO - 10.1128/jcm.00562-26
UR - https://doi.org/10.1128/jcm.00562-26
AB - Etiological diagnosis of lower respiratory tract infections (LRTIs) relies on sputum or bronchoalveolar lavage (BAL), which may be difficult to obtain or invasive. Exhaled breath aerosol (XBA) sampling offers a noninvasive alternative for pathogen detection. We evaluated the performance of the AveloMask, a face mask-based device designed to capture XBAs for molecular testing. In this prospective paired-sample study, hospitalized adults with pneumonia at three hospitals in Switzerland and Georgia provided an XBA sample using the AveloMask and a lower respiratory tract (LRT) specimen (sputum or BAL). XBA samples were analyzed by multiplex PCR using the Roche LightMix® panel, and LRT samples were tested using the BioFire® FilmArray® Pneumonia Panel. Concordance between XBA and LRT samples was assessed using positive percent agreement (PPA), negative percent agreement (NPA), and overall percent agreement (OPA). A total of 93 participants were enrolled, and 63 participants provided paired samples. AveloMask sampling identified the dominant pathogen (lowest Ct value in the LRT sample) in 40/47 LRT-positive cases (85.1%). Across all targets, PPA was 61% (95% CI, 50%–72%), NPA was 99.8% (95% CI, 99%–100%), and OPA was 95% (95% CI, 92%–96%). PPA was higher for bacteria than for viruses, and lower PPA was largely driven by reduced detection of low-abundance or co-infecting pathogens. In an exploratory subset analysis, AveloMask results overlapped with standard-of-care testing and may have informed antimicrobial decision-making. Breath aerosol sampling using the AveloMask enabled noninvasive molecular detection of LRT pathogens in pneumonia cases and may complement conventional standard-of-care testing, particularly when sputum is unavailable. IMPORTANCE: Pneumonia diagnosis often relies on sputum samples, which many patients cannot provide, or bronchoscopy, which is invasive. This study evaluated a user-friendly face mask that captures exhaled aerosols released during normal breathing and coughing for laboratory testing. In hospitalized patients with pneumonia, the mask identified the most abundant pathogen in most cases and was well tolerated in routine clinical care. These findings show that breath aerosol sampling could provide a practical, noninvasive complement to existing diagnostic methods, especially when sputum is unavailable or difficult to obtain. By making lower respiratory tract (LRT) sampling easier and more accessible, this approach could support faster, more targeted treatment decisions, reduce unnecessary antibiotic use, and expand opportunities for molecular diagnosis in hospitals and other healthcare settings. This study is registered with ClinicalTrials.gov as NCT06668883.
SN - 0095-1137
SN - 1098-660X
ER -