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

NCT04583319 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2024-05-23

No results posted yet for this study

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).

Conditions

  • SARS-CoV

Interventions

DIAGNOSTIC_TEST

EasyCov POC

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.

Sponsors & Collaborators

  • Istanbul University

    collaborator OTHER

  • Firalis SA

    lead INDUSTRY

Principal Investigators

  • Arif Atahan, Prof.MD · Istanbul University Istanbul Faculty of Medicine (ITF), Turkey

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-12-12
Primary Completion
2021-12-30
Completion
2021-12-30

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04583319 on ClinicalTrials.gov