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

Sponsor
Carilion Clinic (Other)
Overall Status
Terminated
CT.gov ID
NCT04610489
Collaborator
(none)
117
Enrollment
1
Location
1
Arm
3.8
Actual Duration (Months)
30.4
Patients Per Site Per Month

Study Details

Study Description

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
  • Diagnostic Test: Quidel Sofia SARS Antigen FIA
 N/A

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

Study Type:
Interventional
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 :
Nov 13, 2020
Actual Primary Completion Date :
Mar 10, 2021
Actual Study Completion Date :
Mar 10, 2021

Arms and Interventions

Arm Intervention/Treatment
Other: 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

Primary Outcome Measures

  1. Proportion of True Positives [1 day]

    Of all Disease (rtPCR) Positive subjects, the proportion who were Test (antigen) Positive (sensitivity).

  2. Proportion of True Negatives [1 day]

    Of all Disease (rtPCR) Negative subjects, the proportion who were Test (antigen) Negative (specificity).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Carilion Clinic Roanoke Virginia United States 24016

Sponsors and Collaborators

  • Carilion Clinic

Investigators

  • Principal Investigator: John W Epling, MD, Carilion Clinic

Study Documents (Full-Text)

More Information

Additional Information:

Publications

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
First Posted:
Oct 30, 2020
Last Update Posted:
Aug 17, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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, Medical Director of Research, Department of Family Medicine, Carilion Clinic
diagnostic test
antigen test
PCR test
symptomatic
Additional relevant MeSH terms:
COVID-19

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group Title Study Population
Arm/Group Description All subjects were aged 18 years or older and had symptoms consistent with COVID-19 (as assessed by their clinicians) for five days or less. All subjects underwent 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) via nasopharyngeal swab.
Period Title: Overall Study
STARTED 117
COMPLETED 117
NOT COMPLETED 0

Baseline Characteristics

Arm/Group Title Study Population
Arm/Group Description All subjects were aged 18 years or older and had symptoms consistent with COVID-19 (as assessed by their clinicians) for five days or less. All subjects underwent 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) via nasopharyngeal swab.
Overall Participants 117
Age, Customized (Count of Participants)
Age
0
0%
Sex/Gender, Customized (Count of Participants)
Gender
0
0%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
United States
117
100%

Outcome Measures

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

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Study Population
Arm/Group Description All subjects were aged 18 years or older and had symptoms consistent with COVID-19 (as assessed by their clinicians) for five days or less. All subjects underwent 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) via nasopharyngeal swab.
Measure Participants 117
Number (95% Confidence Interval) [proportion of true positives]
0.750
2. Primary Outcome
Title Proportion of True Negatives
Description Of all Disease (rtPCR) Negative subjects, the proportion who were Test (antigen) Negative (specificity).
Time Frame 1 day

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Study Population
Arm/Group Description All subjects were aged 18 years or older and had symptoms consistent with COVID-19 (as assessed by their clinicians) for five days or less. No other baseline characteristics were collected.
Measure Participants 117
Number (95% Confidence Interval) [proportion of true negatives]
0.988

Adverse Events

Time Frame 1 day
Adverse Event Reporting Description The testing center staff/research coordinators were instructed to contact the Principal Investigator (or the Testing Center manager) for any unanticipated adverse events during the study. The details of the event would have been logged in RedCap. The risk of those events were to be assessed by the PI, appropriate medical care of the subject would have been ensured, and the IRB would have been informed of any event deemed more than minor, or for any event that recurred.
Arm/Group Title Study Population
Arm/Group Description All subjects were aged 18 years or older and had symptoms consistent with COVID-19 (as assessed by their clinicians) for five days or less. All subjects underwent 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) via nasopharyngeal swab.
All Cause Mortality
Study Population
Affected / at Risk (%) # Events
Total 0/117 (0%)
Serious Adverse Events
Study Population
Affected / at Risk (%) # Events
Total 0/117 (0%)
Other (Not Including Serious) Adverse Events
Study Population
Affected / at Risk (%) # Events
Total 0/117 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title John Epling, MD, MSEd
Organization Carilion Clinic
Phone 540-581-0123
Email jwepling@carilionclinic.org
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
First Posted:
Oct 30, 2020
Last Update Posted:
Aug 17, 2021
Last Verified:
Aug 1, 2021