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

Study Overview
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Brief Summary
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During the COVID-19 pandemic, testing primarily relied on the use of nasopharyngeal swabs to detect the SARS-CoV-2 virus, responsible for the disease. However, this technique has several limitations, including the variable quality of swabs, its invasive nature, and arbitrariness in the choice of the number of cycles. Furthermore, it does not allow for the detection of viral proteins. To overcome these limitations, researchers developed the eBAM-CoV test, patented for the detection of viral proteins in the exhaled air of COVID-19 patients. This portable device provides an immediate assessment of the viral load with both quantitative and qualitative results, showing promise for early virus detection. The researchers hypothesize that the eBAM-CoV test is likely to exhibit a satisfactory concordance with the reference RT-PCR test in the detection of COVID-19, especially among symptomatic patients or closed contacts.

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

Conditions
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SARS-CoV-2 Infection, COVID-19, Coronavirus

Intervention / Treatment
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* Device: eBAM Cov Testing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult male or female patients over 18 years of age (≥) Suspected of being infected with COVID-19 (symptomatic or contact case) and consulting for RT-PCR screening. Exclusion Criteria: Inability to understand the procedures to use the device Patient participating in an another interventional study Patient in exclusion period determined by another study Patient under court protection or guardianship Patient/trusted person/legal representative/family member for whom it is impossible to give informed information. Pregnant, parturient or breast-feeding patient

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients likely to be affected by COVID-19<br>The study population consists of adult people who are likely to be affected by COVID-19 (symptomatic or close contacts) consulting for RT-PCR screening. | Device: eBAM Cov Testing<br>* Evaluation of presence/absence of infection with SARS-CoV-2 assessed by eBAM-CoV on air exhaled by the patient compared with the presence/absence of infection based on RT-PCR testing of nasopharyngeal swabs<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concordance between eBAM-Cov test and RT -PCR test to detect SARS-CoV -2 infection | Evaluate the performance of the eBAM-CoV test by measuring the concordance between the eBAM-CoV method and the reference RT-PCR method (known as the gold standard) in detecting SARS-CoV-2 in subjects likely to be infected with COVID-19 (symptomatic or closed contacts). | Day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| diagnostic performance of the eBAM-CoV test | Preliminarily assess the diagnostic performance of the eBAM-CoV test by measuring the sensitivity/specificity between the eBAM-CoV method and the reference RT-PCR method (known as the gold standard) for detecting SARS-CoV-2 in subjects likely to be infected with COVID-19 (symptomatic or closed contact). | Day 0 | 
| concentration of SARS-CoV-2 viral proteins | Correlation between the concentration of SARS-CoV-2 viral proteins assessed by the eBAM-CoV test (eBAM-Unit) and the mean number of copies of mRNA encoding a protein fraction of SARS-CoV-2 viral proteins assessed using the RT-PCR technique | Day 0 | 
| Early detection of SARS-CoV-2 using eBAM-CoV test versus RT-PCR | Number of patients detected as positive by eBAM-CoV and negative by RT-PCR at Day 0 whose RT-PCR test becomes positive at Day 4 | Day 4 | 
| Concordance between eBAM-CoV test and antigenic test | Concordance between the eBAM-CoV method and the antigenic test in patients likely to be infected with COVID-19 and volunteering for a second nasopharyngeal swab | Day 0 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diagnostic Test Kits