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

Not Applicable

Terminated

• Conditions: Covid-19
• Interventions: Diagnostic Test: Quidel Sofia SARS Antigen FIA

• Registration Number: NCT04610489
• Lead Sponsor: Carilion Clinic

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.

Study Timeline

• Study First Submitted: 2020-10-27
• Study First Submitted QC: 2020-10-29
• Study First Posted: 2020-10-30
• Study Start: 2020-11-13
• Primary Completion: 2021-03-10
• Study Completion: 2021-03-10
• Results First Submitted: 2021-06-28
• Status Verified: 2021-08
• Results First Submitted QC: 2021-08-15
• Last Update Submitted: 2021-08-15
• Results First Posted: 2021-08-17
• Last Update Posted: 2021-08-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 117

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Study Population	Quidel Sofia SARS Antigen FIA	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).

Primary Outcome Measures

Name	Time	Method
Proportion of True Positives	1 day	Of all Disease (rtPCR) Positive subjects, the proportion who were Test (antigen) Positive (sensitivity).
Proportion of True Negatives	1 day	Of all Disease (rtPCR) Negative subjects, the proportion who were Test (antigen) Negative (specificity).

Trial Locations

Locations (1)

Carilion Clinic; 🇺🇸 Roanoke, Virginia, United States