Covid-19
Conditions
Keywords
diagnostic test, antigen test, PCR test, symptomatic
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.
Interventions
DIAGNOSTIC_TESTQuidel Sofia SARS Antigen FIA
Obtained via bilateral mid-turbinate swab.
Sponsors
Carilion Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
simultaneous acquisition of both test of interest and reference standard without contingency
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Study Population 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. | 117 |
| Total | 117 |
Baseline characteristics
| Characteristic | Study Population | — |
|---|---|---|
| Age, Customized Age | 0 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 117 participants | — |
| Sex/Gender, Customized Gender | 0 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 117 |
| other Total, other adverse events | 0 / 117 |
| serious Total, serious adverse events | 0 / 117 |
Outcome results
Primary
Proportion of True Negatives
Of all Disease (rtPCR) Negative subjects, the proportion who were Test (antigen) Negative (specificity).
Time frame: 1 day
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Study Population | Proportion of True Negatives | 0.988 proportion of true negatives |
Primary
Proportion of True Positives
Of all Disease (rtPCR) Positive subjects, the proportion who were Test (antigen) Positive (sensitivity).
Time frame: 1 day
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Study Population | Proportion of True Positives | 0.750 proportion of true positives |