Ignite Creation Date:
2024-05-06 @ 7:49 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06144333
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-15
First Post:
2023-11-17
Brief Title:
Collection of Additional Biological Samples From Potentially COVID-19 Patients for Monitoring of Biological Parameters Carried Out as Part of the Routine
Sponsor:
CerbaXpert
Organization:
CerbaXpert
Study Overview
Official Title:
Collection of Additional Biological Samples From Potentially COVID-19 Patients for Monitoring of Biological Parameters Carried Out as Part of the Routine
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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:
CEB Covid-19
Brief Summary:
Patients infected with SARS-CoV-2 can present with a wide range of manifestations clinical conditions ranging from no symptoms to serious or chronic illness The current gold standard test for the diagnosis of COVID-19 is based on a molecular test of reverse transcription polymerase chain reaction RT-PCR aimed at detecting the RNA of the virus in respiratory samples such as nasopharyngeal swabs or aspirates bronchial other methods such as antigen tests and serological detection tests IgM and IgG in response to COVID-19 viral infection can be used for the purposes of screening in the general population
In this context of variety of existing tests it is important to monitor the biological parameters related to COVID-19 pathology by tracking the accuracy specificity and sensitivity of these tests in current clinical practice
This research is a collection of additional biological samples with minimal impact on the intake usual care of the patients concerned for the monitoring of biological parameters carried out in routine on several reagent kits used for screening for the SARS-CoV-2 virus in terms of sensitivity specificity positive and negative predictive values for the implementation of indicators quality monitoring of these kits
In this context of variety of existing tests it is important to monitor the biological parameters related to COVID-19 pathology by tracking the accuracy specificity and sensitivity of these tests in current clinical practice
This research is a collection of additional biological samples with minimal impact on the intake usual care of the patients concerned for the monitoring of biological parameters carried out in routine on several reagent kits used for screening for the SARS-CoV-2 virus in terms of sensitivity specificity positive and negative predictive values for the implementation of indicators quality monitoring of these kits
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