Clinical Evaluation of a Point-of-Care (POC), COVID-19 Rapid Antigen Test (CoviDx™)

Study Overview
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Brief Summary
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Prospective study that will evaluate the clinical agreement of the CoviDx™ Rapid Antigen test compared to SARS-CoV-2 RT-PCR.

Detailed Description
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All patients who present with Covid-19-like symptoms within 5 days prior to consult, who consent to participate in the study, will undergo a nasopharyngeal swab (NP) collected for SARS-CoV-2 RT-PCR with EUA as per standard of care and nasal swab collection for CoviDx Rapid Antigen testing.

Official Title
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Clinical Evaluation of a Point-of-Care (POC), SARS-CoV-2 CoviDx™ Rapid Antigen Test

Conditions
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Covid19, SARS-CoV-2

Intervention / Treatment
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* Device: POC CoviDx™ Rapid Antigen Test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Nasopharyngeal swab collected for SARS-CoV-2 RT-PCR with EUA as per standard of care within 3 hours of CoviDx Rapid Antigen Swab collection First onset of COVID-19-like symptoms within the last 5 days ≥ 1 year of age Signed Informed Consent Exclusion Criteria: Unable or unwilling to provide signed, Informed Consent Less than 1 year of age SARS-Cov-2 RT-PCR collection that occurred > 3 hours from CoviDx Rapid Antigen Swab collection First onset of COVID-19-like symptoms occurring more than 5 days from study visit Invalid or missing PCR test results Use of a non-high-sensitive SARS-CoV-2 test as the qualifying SARS-CoV-2 RT-PCR test (e.g., Abbott ID NOW, rapid antigen tests, tests that do not have FDA EUA, a test that was not approved by Sponsor for use in the study) Enrollment in another study involving the collection of a nasopharyngeal or nasal swab Receipt of a COVID-19 vaccine or participation in a COVID-19 vaccine study

Ages Eligible for Study
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Minimum Age: 1 Year

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| SARS-Cov-2 RT-PCR AND CoviDx Rapid Antigen Testing<br>Sequentially enrolled symptomatic patients who present for COVID-19 testing and have a swab collected for high-sensitive, SARS-CoV-2 RT-PCR testing per Standard of Care AND a swab for CoviDx™ Rapid Antigen testing. | Device: POC CoviDx™ Rapid Antigen Test<br>* All patients will have a nasal swab for CoviDx™ Rapid Antigen testing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of SARS-CoV-2 antigen in nasal swab as compared to a high-sensitive SARS-CoV-2 RT-PCR granted Emergency Use Authorization (EUA) by the FDA | The primary outcome is the presence of SARS-CoV-2 antigen in nasal swab as compared to confirmatory diagnosis SARS-CoV-2 as determined by a high-sensitive SARS-CoV-2 RT-PCR granted Emergency Use Authorization (EUA) by the FDA | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Antigen, Rapid, Point of care testing