An observational study in SARS-CoV, sponsored by Firalis SA. Completed at 1 site in Turkey. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-23.
Sponsored by Firalis SA · Observational
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).
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:
Secondary Objectives:
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
Recruitment will be carried out on patients suspected to have contracted COVID-19 and to be screened by RT-PCR test, according to decision of her/his physician. These patients are routinely screened by a Turkish MOH and FDA approved RT-PCR test for COVID-19 and will be allocated to SARS-COV-2 Positive or Control group based on results obtained from RT-PCR.
Non-specific inclusion criteria:
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
Exclusion Criteria:
patients tested positive for SARS-CoV-2 by routine Turkish MOH and FDA approved RT-PCR IVD test.
Diagnostic Test: EasyCov POC
participants tested negative for SARS-CoV-2 by routine Turkish MOH and FDA approved RT-PCR IVD test.
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.
Positive percent agreement (PPA)
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.
Time frame: 1 month
Performance
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.
Time frame: 1 month
Plan to share: No
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This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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Firalis SA