NCT04282135

Detection of Influenza or SARS-CoV-2 Infection by IMS of Nasal Air Sampling

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 76 (actual)
• Sponsor: Klinikum Bayreuth GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Multicapillary Ion mobility spectrometry of nasal air aspirates shall be investigated as screening tool for the detection of Influenza and SARS-CoV-2- infection.

Detailed description

Bacterial infections can be distinguished by analysis of the volatile organic compounds found in breath. In patients with suspected Influenza infection, nasal air samples will be taken and analyzed by Multicapillary Ion mobility spectrometry (MCC IMS). Routinely all patients undergo polymerase chain reaction (PCR) analysis of nasopharyngeal swabs for Influenza. MCC IMS spectra will be compared between infected and non infected patients by cluster analysis and discrimination analysis. If the number of infected patients exceeds 50 an additional validation cohort will be investigated sequentially otherwise validation will be performed during the Influenza epidemic 2021. Due to decreasing numbers of Influenza-A- Infections study was opened to also include patients with suspected SARS-CoV-2 infections.

Conditions

• Influenza

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	MCC IMS	Diagnosis by MCC IMS

Timeline

• Start date: 2020-02-15
• Primary completion: 2020-05-08
• Completion: 2020-06-30
• First posted: 2020-02-24
• Last updated: 2020-07-14

Locations

1 site across 1 country: Germany