Breath Analysis for SARS-CoV-2 in Infected and Healthy Subjects
- Conditions
- SARS-CoV-2 Infection
- Interventions
- Diagnostic Test: Multicapillary column coupled ion mobility spectrometry
- Registration Number
- NCT04547114
- Lead Sponsor
- Klinikum Bayreuth GmbH
- Brief Summary
Recently published studies could demonstrate that detection of specific biomarkers in breath could be applied for the diagnosis of SARS-CoV-2.
- Detailed Description
In this study we want to address the sensitivity and specificity of breath analysis by MCC-IMS in the context of SARS-CoV-2 detection from PCR- proven infected and non-infected subjects.
Therefore nasal breath will be aspirated for 10 seconds during normal respiration by a foam cuffed oxygen catheter connected via a 0.22μm filter and a line into the MCC-IMS and directly analyzed without any pre-analytic procedures.
The during the proof-of-concept study derived significant peaks for volatile organic compounds will be used for discrimination in a point-of-care approach.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
hospital admission staff members
too sick to comply with study procedures
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description SARS-CoV-2- infected Multicapillary column coupled ion mobility spectrometry Detection of SARS-CoV-2 RNA by PCR in nasopharyngeal/oropharyngeal swabs non infected Multicapillary column coupled ion mobility spectrometry Lack of detection of SARS-CoV-2 RNA by PCR in nasopharyngeal/oropharyngeal swabs
- Primary Outcome Measures
Name Time Method correct classification of SARS-CoV-2 infected and not infected subjects 6 months correct classification of SARS-CoV-2 infected and not infected subjects
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Klinikum Bayreuth/ Bayreuth General Hospital
🇩🇪Bayreuth, Germany