Diagnostic Performance of an Antigen Test for SARS-CoV-2 Infection (COVID-19)

Study Overview
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Brief Summary
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A comparison of a direct antigen test for SARS-CoV-2 obtained by mid-turbinate swab with the reference standard rt-PCR test obtained by nasopharyngeal swab in outpatients with symptoms compatible with COVID-19.

Detailed Description
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This study plans to compare a direct antigen test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) obtained by mid-turbinate nasal swab with a reverse transcription polymerase chain reaction (rt-PCR) test obtained by nasopharyngeal swab (the current reference standard) in a population of patients with symptoms suggestive of COVID-19 for fewer than 5 days. Subjects whose physicians have already ordered an rt-PCR test at a Carilion testing center will be screened and recruited by phone during a required scheduling call. The study coordinator will describe the study by phone, and the subject will be consented when they arrive at the testing center. After consenting, a mid-turbinate swab direct antigen test will be obtained just prior to the ordered nasopharyngeal swab and any other ordered tests. The subjects will receive their rt-PCR test results through the usual channels of clinical notification. The subjects will not receive their nasal antigen results. The antigen test results will be analyzed in a batch process and the results entered into RedCap by the study staff. The rt-PCR results will be extracted from the Epic electronic health record using patient identifiers and paired with the corresponding antigen result for statistical analysis.

Official Title
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Diagnostic Performance of an Antigen Test for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection (COVID-19)

Conditions
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Covid-19

Intervention / Treatment
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* Diagnostic Test: Quidel Sofia SARS Antigen FIA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Acutely ill with one or more COVID-19 symptoms Exclusion Criteria: Unable to speak English Unable to provide written informed consent Symptoms have lasted longer than 5 days Currently hospitalized

Ages Eligible for Study
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Minimum Age: 18 Years

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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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Study Population<br>All subjects will undergo bilateral mid-turbinate swabs for COVID Antigen (Quidel Sofia SARS Antigen Fluorescent Immunoassay (FIA)) as well as bilateral rt-PCR testing (Quest SARS-CoV-2 rRT-PCR). | Diagnostic Test: Quidel Sofia SARS Antigen FIA<br>* Obtained via bilateral mid-turbinate swab.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of True Positives | Of all Disease (rtPCR) Positive subjects, the proportion who were Test (antigen) Positive (sensitivity). | 1 day | 
| Proportion of True Negatives | Of all Disease (rtPCR) Negative subjects, the proportion who were Test (antigen) Negative (specificity). | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diagnostic test, antigen test, PCR test, symptomatic