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

Bayreuth Clinic

Status: Completed

Conditions: Influenza

Treatments: Diagnostic Test: MCC IMS

Study type: Observational

Funder types: Industry

Identifiers

NCT04282135

IMS 1

Details and patient eligibility

About

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

Full 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.

Enrollment: 76 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• suspected Influenza infection

Exclusion criteria

• later than 48h after admission and detection of Influenza infection
• later than 32 days after admission and detection of SARS-CoV-2- infection
• no written consent

Trial design

76 participants in 3 patient groups

Infected

Description:

patients with detected Influenza RNA in nasopharyngeal swabs

Treatment:

Diagnostic Test: MCC IMS

not infected

Description:

patients without detected Influenza RNA in nasopharyngeal swabs

Treatment:

Diagnostic Test: MCC IMS

SARS CoV2

Description:

patients with SARS-Cov-2 infection

Treatment:

Diagnostic Test: MCC IMS