RecruitingNot ApplicableNCT06099795

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

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


Sponsor

Centre Hospitalier Universitaire de Nīmes

Enrollment

250 participants

Start Date

Jan 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria2

  • 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 Criteria6

  • 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

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Interventions

DEVICEeBAM 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


Locations(2)

Laboratoire Alphabio, Hôpital Européen Marseille

Marseille, France

CHU de NIMES

Nîmes, France

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NCT06099795


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