Rapid point-of-care detection of SARS-CoV-2 infection in exhaled breath using ion mobility spectrometry: a pilot study

• Published in: European journal of medical research 2023-09, Vol.28 (1), p.1-318, Article 318
• Main Authors: Voit, Florian, Erber, J, Feuerherd, M, Fries, H, Bitterlich, N, Diehl-Wiesenecker, E, Gladis, S, Lieb, J, Protzer, U, Schneider, J, Geisler, F, Somasundaram, R, Schmid, R. M, Bauer, W, Spinner, C. D
• Format: Article
• Language: English
• Subjects: Analysis; Antigens; Breath gas analysis; Coronaviruses; COVID-19; Data analysis; Health aspects; Hospitals; Infections; Ion mobility spectrometry; Ions; Medical equipment and supplies industry; Medical test kit industry; Pandemics; Patients; Pilot projects; Polymerase chain reaction; SARS-CoV-2; Scientific imaging; Severe acute respiratory syndrome; Severe acute respiratory syndrome coronavirus 2; Software; Spectrum analysis; Ultrasonic imaging; VOCs; Volatile organic compounds
• ISSN: 2047-783X; 0949-2321; 2047-783X
• DOI: 10.1186/s40001-023-01284-3

Background An effective testing strategy is essential for pandemic control of the novel Coronavirus disease 2019 (COVID-19) caused by infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Breath gas analysis can expand the available toolbox for diagnostic tests by using a rapid, cost-beneficial, high-throughput point-of-care test. We conducted a bi-center clinical pilot study in Germany to evaluate breath gas analysis using multi-capillary column ion mobility spectrometry (MCC-IMS) to detect SARS-CoV-2 infection. Methods Between September 23, 2020, and June 11, 2021, breath gas measurements were performed on 380 patients (SARS-CoV-2 real-time polymerase chain reaction (PCR) positive: 186; PCR negative: 194) presenting to the emergency department (ED) with respiratory symptoms. Results Breath gas analysis using MCC-IMS identified 110 peaks; 54 showed statistically significant differences in peak intensity between the SARS-CoV-2 PCR-negative and PCR-positive groups. A decision tree analysis classification resulted in a sensitivity of 83% and specificity of 86%, but limited robustness to dataset changes. Modest values for the sensitivity (74%) and specificity (52%) were obtained using linear discriminant analysis. A systematic search for peaks led to a sensitivity of 77% and specificity of 67%; however, validation by transferability to other data is questionable. Conclusions Despite identifying several peaks by MCC-IMS with significant differences in peak intensity between PCR-negative and PCR-positive samples, finding a classification system that allows reliable differentiation between the two groups proved to be difficult. However, with some modifications to the setup, breath gas analysis using MCC-IMS may be a useful diagnostic toolbox for SARS-CoV-2 infection. Trial registration: This study was registered at ClinicalTrials.gov on September 21, 2020 (NCT04556318; Study-ID: HC-N-H-2004). Keywords: COVID-19, SARS-CoV-2, Breath gas analysis, Ion mobility spectrometry