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

NCT04610489 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 117

Last updated 2021-08-17

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

DIAGNOSTIC_TEST

Quidel Sofia SARS Antigen FIA

Obtained via bilateral mid-turbinate swab.

Sponsors & Collaborators

  • Carilion Clinic

    lead OTHER

Principal Investigators

  • John W Epling, MD · Carilion Clinic

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-13
Primary Completion
2021-03-10
Completion
2021-03-10
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04610489 on ClinicalTrials.gov