Detection of SARS-CoV-2 Infection by Multicapillary Column Coupled Ion Mobility Spectrometry (MCC-IMS) of Breath: A Proof of Concept Study

Abstract

There is an urgent need for screening patients of having a communicable viral disease to cut infection chains. We could recently demonstrate that MCC-IMS of breath is able to identify Influenza-A infected patients. With decreasing Influenza epidemic and upcoming SARS-CoV-2 infections we extended our study to the analysis of patients with suspected SARS-CoV-2 infections. 51 patients, 23m, 28f, aged 64 ± 16 years, were included in this study. Besides RT-PCR analysis of nasopharyngeal swabs all patients underwent MCC-IMS analysis of breath. 16 patients, 7m, 9f, were positive for SARS-CoV-2 by RT-PCR. There was no difference in gender or age according to the groups. Stepwise canonical discriminant analysis could correctly classify the infected and non-infected subjects in 98% by cross-validation. Afterwards we combined the Influenza-A sub study and the SARS-CoV-2- sub study for a total of 75 patients, 34m, 41f, aged 64·8 ± 1·8 years, 14 positive for Influenza-A, 16 positive for SARS-CoV-2, the remaining 44 patients were used as controls. In one patient RT-PCR was highly suspicious of SARS-CoV-2 but inconclusive. There was no imbalance between the groups for age or gender. 97·3% of the patients could be correctly classified to the respective group by discriminant analysis. Even the inconclusive patient could be mapped to the SARS-CoV-2 group applying the discrimination function. Conclusion: MCC-IMS is able to detect SARS-CoV-2 infection and Influenza-A infection in breath. As this method provides exact, fast non-invasive diagnosis it should be further developed for screening of communicable viral diseases. Study Registration: NCT04282135. Funding Statement: There was no external funding. Declaration of Interests: Gunther Becher is Consultant to Graupner medical solutions GmbH, Geyer, Germany Gunther Becher holds parts of the patent for the cluster analysis (EP 2 729 801 B1) All other authors state that there is no conflict of interests. Ethics Approval Statement: After written consent breath samples were taken and analysed by MCC-IMS. The study was approved by the Ethics Committee of Erlangen University, Erlangen, Germany (Nr 426_18B).