Clinical trial NCT04610489: Diagnostic Performance of an Antigen Test for SARS-CoV-2 Infection (COVID-19)
Official title: Diagnostic Performance of an Antigen Test for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection (COVID-19)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Covid-19
Keywords: diagnostic test
antigen test
PCR test
symptomatic
Lead sponsor: Carilion Clinic
Sponsor class: OTHER
First posted: 2020-10-30
Enrollment: 117
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of True Positives
timeFrame: 1 day
measure: Proportion of True Negatives
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Roanoke
country: United States
facility: Carilion Clinic
state: Virginia
Study officials:
affiliation: Carilion Clinic
name: John W Epling, MD
role: PRINCIPAL_INVESTIGATOR
References:
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