Rapid detection of SARS-CoV-2 infection by multicapillary column coupled ion mobility spectrometry (MCC-IMS) of breath. A proof of concept study
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Abstract
There is an urgent need for screening of patients with a communicable viral disease to cut infection chains. Recently, we demonstrated that ion mobility spectrometry coupled with a multicapillary column (MCC-IMS) is able to identify influenza-A infections in patients’ breath. With a decreasing influenza epidemic and upcoming SARS-CoV-2 infections we proceeded further and analyzed patients with suspected SARS-CoV-2 infections. In this study, the nasal breath of 75 patients (34 male, 41 female, aged 64.4 ± 15.4 years) was investigated by MCC-IMS for viral infections. Fourteen were positively diagnosed with influenza-A infection and sixteen with SARS-CoV-2 by reverse transcription polymerase chain reaction (RT-PCR) of nasopharyngeal swabs. In one patient RT-PCR was highly suspicious of SARS-CoV-2 but initially inconclusive. The remaining 44 patients served as controls. Breath fingerprints for specific infections were assessed by a combination of cluster analysis and multivariate statistics. There were no significant differences in gender or age according to the groups. In the cross validation of the discriminant analysis 72 of the 74 clearly defined patients could be correctly classified to the respective group. Even the inconclusive patient could be mapped to the SARS-CoV-2 group by applying the discrimination functions. Conclusion: SARS-CoV-2 infection and influenza-A infection can be detected with the help of MCC-IMS in breath in this pilot study. As this method provides a fast non-invasive diagnosis it should be further developed in a larger cohort for screening of communicable viral diseases. A validation study is ongoing during the second wave of COVID-19.
Trial registration: ClinicalTrial.gov, NCT04282135 Registered 20 February 2020—Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT04282135?term=IMS&draw=2&rank=1
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SciScore for 10.1101/2020.06.30.20143347: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement IRB: The study was approved by the Ethics Committee of Erlangen University #426_18_B and registered at ClinicalTrials.gov (NCT04282135).
Consent: Unfortunately, many patients could not be included as they were too sick and had to be transferred to the intensive care unit or were unable to provide written consent.Randomization not detected. Blinding not detected. Power Analysis not detected. Sex as a biological variable During the influenza-A epidemic 202015 11 male, 13 female, aged 66 ± 14.2 years and during the SARS-CoV-2-pandemic 23 male, 28 female, aged 63 ± 16 years with suspected infections were asked to participate in the study. Table 2: Resources
… SciScore for 10.1101/2020.06.30.20143347: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement IRB: The study was approved by the Ethics Committee of Erlangen University #426_18_B and registered at ClinicalTrials.gov (NCT04282135).
Consent: Unfortunately, many patients could not be included as they were too sick and had to be transferred to the intensive care unit or were unable to provide written consent.Randomization not detected. Blinding not detected. Power Analysis not detected. Sex as a biological variable During the influenza-A epidemic 202015 11 male, 13 female, aged 66 ± 14.2 years and during the SARS-CoV-2-pandemic 23 male, 28 female, aged 63 ± 16 years with suspected infections were asked to participate in the study. Table 2: Resources
Software and Algorithms Sentences Resources For the statistical analysis we used IBM SPSS 22.0 (IBM, Armonk, NY). SPSSsuggested: (SPSS, RRID:SCR_002865)Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).
Results from LimitationRecognizer: An explicit section about the limitations of the techniques employed in this study was not found. We encourage authors to address study limitations.Results from TrialIdentifier: We found the following clinical trial numbers in your paper:
Identifier Status Title NCT04282135 Completed Detection of Influenza or SARS-CoV-2 Infection by IMS of Nas… Results from Barzooka: We did not find any issues relating to the usage of bar graphs.
Results from JetFighter: We did not find any issues relating to colormaps.
Results from rtransparent:- Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
- Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
- No protocol registration statement was detected.
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