Validation of a Rapid, Non-invasive Point-of-care IVD Test for Diagnosis of SARS-COV-2 (COVID-19) Infection
NCT ID: NCT04583319
Last Updated: 2024-05-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
300 participants
OBSERVATIONAL
2020-12-12
2021-12-30
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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SARS-CoV-2 Positive
patients tested positive for SARS-CoV-2 by routine Turkish MOH and FDA approved RT-PCR IVD 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.
SARS-CoV-2 Negative
participants tested negative for SARS-CoV-2 by routine Turkish MOH and FDA approved RT-PCR IVD 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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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
* Refusal to sign the consent.
18 Years
ALL
Yes
Sponsors
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Istanbul University
OTHER
Firalis SA
INDUSTRY
Responsible Party
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Principal Investigators
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Arif Atahan, Prof.MD
Role: PRINCIPAL_INVESTIGATOR
Istanbul University Istanbul Faculty of Medicine (ITF), Turkey
Locations
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Istanbul University Istanbul Faculty of Medicine (ITF)
Istanbul, , Turkey (Türkiye)
Countries
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Other Identifiers
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ST0194
Identifier Type: -
Identifier Source: org_study_id
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