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Recently published studies could demonstrate that detection of specific biomarkers in breath could be applied for the diagnosis of SARS-CoV-2.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SARS-CoV-2- infected | Detection of SARS-CoV-2 RNA by PCR in nasopharyngeal/oropharyngeal swabs |
| |
| non infected | Lack of detection of SARS-CoV-2 RNA by PCR in nasopharyngeal/oropharyngeal swabs |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multicapillary column coupled ion mobility spectrometry | Diagnostic Test | sampling of nasal air via a foam cuffed oxygen catheter |
|
| Measure | Description | Time Frame |
|---|---|---|
| correct classification of SARS-CoV-2 infected and not infected subjects | correct classification of SARS-CoV-2 infected and not infected subjects | 6 months |
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Inclusion Criteria:
hospital admission staff members
Exclusion Criteria:
too sick to comply with study procedures
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Adult subjects of all genders and ages
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum Bayreuth/ Bayreuth General Hospital | Recruiting | Bayreuth | 95445 | Germany |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |