NCT04610489

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 117 (actual)
• Sponsor: Carilion Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Covid-19

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Quidel Sofia SARS Antigen FIA	Obtained via bilateral mid-turbinate swab.

Timeline

• Start date: 2020-11-13
• Primary completion: 2021-03-10
• Completion: 2021-03-10
• First posted: 2020-10-30
• Last updated: 2021-08-17
• Results posted: 2021-08-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study