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OpenTrials
Completed

NCT Number: NCT04583319

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

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).

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Key information

Conditions

SARS-CoV COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Severe Acute Respiratory Syndrome Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Istanbul University Istanbul Faculty of Medicine (ITF)

Istanbul, Turkey (Türkiye)

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Non-specific inclusion criteria:

  • Participant aged 18 and above
  • Participant agreeing to follow the study procedures
  • Participant able to understand the purpose, nature and methodology of the study
  • 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.

Treatment and study plan

EasyCov POC

Diagnostic Test

Saliva samples will be collected according to the sampling protocol defined each for EASYCOV test. The EasyCoV test will be performed at the beginning of the study before obtaining the routine RT- PCR test results. The operators performing this test will be blinded from the routine RT-PCR results.

Primary outcomes

  1. Positive percent agreement (PPA)

    Time frame: 1 month

    A positive percent agreement (PPA) of EASYCOV PoC assay will be corroborated with the routine Turkish MOH and FDA approved reference method RT-PCR using nasopharyngeal samples.

Secondary outcomes

  1. Performance

    Time frame: 1 month

    The performance (accuracy, sensitivity, specificity, positive predictive value, negative predictive value) of EASYCOV POC assay will be evaluated compared to the routine Turkish MOH and FDA approved RT-PCR method using nasopharyngeal samples.

Sponsors and collaborators

Lead sponsor

Firalis SA

Industry

Collaborators

  • Istanbul University

Registry information

Official study 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

Acronym: EasyCov

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 12, 2020
Registry last updated
May 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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