Ignite Creation Date:
2024-05-06 @ 7:41 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06099795
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-10-25
First Post:
2023-10-18
Brief Title:
Evaluation of Concordance Between Exhaled Air Test eBAM-CoV and RT-PCR to Detect SARS-CoV-2
Sponsor:
Centre Hospitalier Universitaire de Nīmes
Organization:
Centre Hospitalier Universitaire de Nīmes
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
eBAM_CoV
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None