Evaluation of Concordance Between Exhaled Air Test (eBAM-CoV) and RT-PCR to Detect SARS-CoV-2
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: eBAM Cov Testing.
- Who it may be relevant to
- Registry conditions: SARS-CoV-2 Infection, COVID-19, Coronavirus. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Interventions
- Device eBAM Cov Testing
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
Primary outcome measures
- Concordance between eBAM-Cov test and RT -PCR test to detect SARS-CoV -2 infection [Time frame: Day 0]
Secondary outcome measures (4)
- diagnostic performance of the eBAM-CoV test [Time frame: Day 0]
- concentration of SARS-CoV-2 viral proteins [Time frame: Day 0]
- Early detection of SARS-CoV-2 using eBAM-CoV test versus RT-PCR [Time frame: Day 4]
- Concordance between eBAM-CoV test and antigenic test [Time frame: Day 0]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
France · 2 centers
- CHU de NIMES — Nîmes
- Université de Nîmes — Nîmes
Identifiers
NCT: NCT06099795 · IDIL/2022/VC-01