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

Firalis

Status: Completed

Conditions: SARS-CoV

Treatments: Diagnostic Test: EasyCov POC

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04583319

ST0194

Details and patient eligibility

About

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).

Full 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

Enrollment: 300 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Non-specific inclusion criteria:

1. Participant aged 18 and above
2. Participant agreeing to follow the study procedures
3. Participant able to understand the purpose, nature and methodology of the study
4. Participant having signed the informed consent

Specific inclusion criteria:

SARS-COV-2 positive patients - Participants tested positive for the SARS-COV-2 by the routine Turkish MOH and FDA approved RT-PCR method.

SARS-COV-2 negative controls

• Participants tested negative for the SARS-COV-2 by the routine Turkish MOH and FDA approved RT-PCR method.

Exclusion criteria

• Minors, persons deprived of their liberty, protected adults or vulnerable persons.
• Refusal to sign the consent.

Trial design

300 participants in 2 patient groups

SARS-CoV-2 Positive

Description:

patients tested positive for SARS-CoV-2 by routine Turkish MOH and FDA approved RT-PCR IVD test.

Treatment:

Diagnostic Test: EasyCov POC

SARS-CoV-2 Negative

Description:

participants tested negative for SARS-CoV-2 by routine Turkish MOH and FDA approved RT-PCR IVD test.

Treatment:

Diagnostic Test: EasyCov POC