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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04610489
Recruitment Status : Terminated (Difficulty with recruiting for the study and with staffing the study.)
First Posted : October 30, 2020
Results First Posted : August 17, 2021
Last Update Posted : August 17, 2021
Sponsor:
Information provided by (Responsible Party):
John W Epling, Carilion Clinic

Study Description
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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.

Condition or disease Intervention/treatment Phase
Covid-19 Diagnostic Test: Quidel Sofia SARS Antigen FIA Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 117 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: simultaneous acquisition of both test of interest and reference standard without contingency
Primary Purpose: Diagnostic
Official Title: Diagnostic Performance of an Antigen Test for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection (COVID-19)
Actual Study Start Date : November 13, 2020
Actual Primary Completion Date : March 10, 2021
Actual Study Completion Date : March 10, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Study Population
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
Obtained via bilateral mid-turbinate swab.


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of True Positives [ Time Frame: 1 day ]
    Of all Disease (rtPCR) Positive subjects, the proportion who were Test (antigen) Positive (sensitivity).

  2. Proportion of True Negatives [ Time Frame: 1 day ]
    Of all Disease (rtPCR) Negative subjects, the proportion who were Test (antigen) Negative (specificity).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04610489


Locations
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United States, Virginia
Carilion Clinic
Roanoke, Virginia, United States, 24016
Sponsors and Collaborators
Carilion Clinic
Investigators
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Principal Investigator: John W Epling, MD Carilion Clinic
  Study Documents (Full-Text)

Documents provided by John W Epling, Carilion Clinic:
Study Protocol and Statistical Analysis Plan  [PDF] October 30, 2020

More Information
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Additional Information:

Publications:

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Responsible Party: John W Epling, Medical Director of Research, Department of Family Medicine, Carilion Clinic
ClinicalTrials.gov Identifier: NCT04610489    
Other Study ID Numbers: IRB-20-1088
Epling-533 ( Other Identifier: Carilion Clinic )
First Posted: October 30, 2020    Key Record Dates
Results First Posted: August 17, 2021
Last Update Posted: August 17, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by John W Epling, Carilion Clinic:
diagnostic test
antigen test
PCR test
symptomatic
Additional relevant MeSH terms:
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COVID-19
Infections
Respiratory Tract Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases