Breath Analysis for SARS-CoV-2 in Infected and Healthy Subjects

Bayreuth Clinic

Status: Unknown

Conditions: SARS-CoV-2 Infection

Treatments: Diagnostic Test: Multicapillary column coupled ion mobility spectrometry

Study type: Observational

Funder types: Industry

Identifiers

NCT04547114

IMS COVID-19

Details and patient eligibility

About

Recently published studies could demonstrate that detection of specific biomarkers in breath could be applied for the diagnosis of SARS-CoV-2.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

hospital admission staff members

Exclusion criteria

too sick to comply with study procedures

Trial design

200 participants in 2 patient groups

SARS-CoV-2- infected

Description:

Detection of SARS-CoV-2 RNA by PCR in nasopharyngeal/oropharyngeal swabs

Treatment:

Diagnostic Test: Multicapillary column coupled ion mobility spectrometry

non infected

Description:

Lack of detection of SARS-CoV-2 RNA by PCR in nasopharyngeal/oropharyngeal swabs

Treatment:

Diagnostic Test: Multicapillary column coupled ion mobility spectrometry