Ignite Creation Date:
2024-05-06 @ 3:18 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04583319
Status:
COMPLETED
Last Update Posted:
2024-05-23
First Post:
2020-09-30
Brief Title:
Validation of a Rapid Non-invasive Point-of-care IVD Test for Diagnosis of SARS-COV-2 COVID-19 Infection
Sponsor:
Firalis SA
Organization:
Firalis SA
Study Overview
Official Title:
A Prospective Non-interventional Study for Validation of a Rapid Non-invasive IVD as a Point-of-care Test for Diagnosis of SARS-COV-2 Infection
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
Recruiting
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:
EasyCov
Brief Summary:
A prospective non-interventional study to evaluate the performance of EASYCOV IVD as point-of-care POC test by comparing SARS-CoV-2 positive patients with SARS-CoV-2 negative controls on paired specimens nasopharyngeal swabs saliva samples
Detailed Description:
A prospective non-interventional study to evaluate the performance of EASYCOV IVD as point-of-care POC test by comparing SARS-CoV-2 positive patients with SARS-CoV-2 negative controls on paired specimens nasopharyngeal swabs saliva samples
The operators performing the diagnostic tests will be blinded from the RT-PCR results ie participants group will be anonymized Participants who have been tested by an routineTurkish MOH and FDA EUA approved RT-PCR test using nasopharyngeal swabs will be included in the study to perform the EASYCOV IVD tests in a POC setting
Primary Objective
To evaluate the performance of EasyCov IVD as a point-of-care POC test performed on saliva samples for the diagnosis of SARS-CoV-2 infection by comparing it to a Turkish MOH and FDA EUA approved RT-PCR test performed on nasopharyngeal samples
Secondary Objectives
Collection and storage of saliva samples nasopharyngeal swabs at D0 to perform future COVID-19 related research projects and validation of future generations of EASYCOV assays as well as exploratory studies to find candidate biomarkers for Covid-19
160 participants will be included in 11 ratio 80 SARS-CoV-2 positive and 80 SARS-CoV-2 negative by a Turkish MOH and FDA approved RT-PCR IVD test
The operators performing the diagnostic tests will be blinded from the RT-PCR results ie participants group will be anonymized Participants who have been tested by an routineTurkish MOH and FDA EUA approved RT-PCR test using nasopharyngeal swabs will be included in the study to perform the EASYCOV IVD tests in a POC setting
Primary Objective
To evaluate the performance of EasyCov IVD as a point-of-care POC test performed on saliva samples for the diagnosis of SARS-CoV-2 infection by comparing it to a Turkish MOH and FDA EUA approved RT-PCR test performed on nasopharyngeal samples
Secondary Objectives
Collection and storage of saliva samples nasopharyngeal swabs at D0 to perform future COVID-19 related research projects and validation of future generations of EASYCOV assays as well as exploratory studies to find candidate biomarkers for Covid-19
160 participants will be included in 11 ratio 80 SARS-CoV-2 positive and 80 SARS-CoV-2 negative by a Turkish MOH and FDA approved RT-PCR IVD test
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