Validation of a Rapid, Non-invasive Point-of-care IVD Test for Diagnosis of SARS-COV-2 (COVID-19) Infection — EasyCov  

SARS-CoV Clinical Trial

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

Clinical Trial 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).

Clinical Trial 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 (i.e. participant's 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 1:1 ratio: 80 SARS-CoV-2 positive and 80 SARS-CoV-2 negative by a Turkish MOH and FDA approved RT-PCR IVD test ;

Related Conditions & MeSH terms

• Infections
• SARS-CoV

• NCT number: NCT04583319
• Study type: Observational
• Source: Firalis SA
• Status: Completed
• Start date: December 12, 2020
• Completion date: December 30, 2021