Evaluation of Concordance Between an Innovative Test on Exhaled Air (eBAM-CoV) and RT-PCR to Detect SARS-CoV-2 in Symptomatic Patients or Close Contacts

What this Trial Is About

Researchers are evaluating the eBAM-CoV test, a new portable device designed to detect viral proteins in the exhaled air of individuals who may have COVID-19, including those with symptoms or who have been in close contact with infected persons. This study aims to compare the eBAM-CoV test with the standard RT-PCR test, which uses nasopharyngeal swabs to detect the virus but has limitations such as invasiveness and variability in test quality. The goal is to see if the eBAM-CoV test shows comparable results, especially for early detection. Participants will be adults suspected of COVID-19 infection undergoing RT-PCR screening. The study involves using the eBAM-CoV device to assess viral protein presence in exhaled air and comparing these results with RT-PCR findings from nasopharyngeal swabs. The test provides immediate qualitative and quantitative results for the viral load. The study also compares the eBAM-CoV test results with antigenic tests and evaluates early detection at a follow-up. During the study, participants will be assessed on the same day for concordance between eBAM-CoV and RT-PCR tests, including measuring the concentration of viral proteins. Additional assessments for early detection will occur on day 4. The researchers will monitor diagnostic performance and agreement between tests. The total participation duration and follow-up are designed to ensure accurate comparison and validation of the new device's performance in detecting SARS-CoV-2 infection.

Evaluation of Concordance Between Exhaled Air Test (eBAM-CoV) and RT-PCR to Detect SARS-CoV-2