COVID-19
Conditions
Keywords
Antigen test, Test, Diagnosis
Brief summary
This study will measure the sensitivity and specificity of the Testing Done Simple severe acute respiratory syndrome (SARS) CoV-2 antigen test in subjects with suspected Covid-19 that present throughout several urgent care clinics. The antigen test performance will be compared to a real-time polymerase chain reaction (RT-PCR) test.
Detailed description
The Testing Done Simple antigen test is a lateral flow immunoassay that detects the presence of the SARS CoV-2 nucleoprotein and is primarily intended for use in an at home setting. The antigen test will be compared to a traditional RT-PCR tested nasal swab specimens. The purpose of study is to measure the performance of the Testing Done Simple test via sensitivity and specificity when compared to the gold-standard RT-PCR test. The test will be administered in symptomatic and asymptomatic subjects and participants will report the days that has passed since their symptom onset. The RT-PCR test will be performed prior to the Testing Done Simple test.
Interventions
DIAGNOSTIC_TESTTesting Done Simple SARS CoV-2 Antigen Test
Collections of specimens from subjects presenting with Covid-19 like symptoms or known/suspected exposure to SARS CoV-2 via nasal swabs administered by trained medical personnel.
Sponsors
Nao Medical Urgent Care
Testing Done Simple
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject was given a SARS CoV 2 PCR test for any of the following 4 reasons: 1. Subject has Covid like symptoms that started within past (7) days 2. Subject has been exposed to another individual with a known Covid diagnosis or probable Covid diagnosis 3. Subject needs Covid test done for travel, school, work, etc 4. Subject works in a high risk environment * Subject can provide a nasal swab sample * Subject is at least 18 years of age * Subject was given a SARS CoV 2 PCR test on same day participating this study * Subject provides informed consent
Exclusion criteria
* Subject is less than 18 years of age * Subject does not provide consent * Subject's Covid 19 related symptom(s) started greater than 7 days from visit * Asymptomatic subjects whom have had symptom(s) within past (14) days * Signs of local infection in the area of the face * Subject was not given a SARS CoV 2 PCR test on same day as study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity | 15 minutes | Sensitivity (True Positive Rate) of Testing Done Simple Antigen Test compared to RT-PCR |
| Specificity | 15 minutes | Specificity (True Negative Rate) of Testing Done Simple Antigen Test compared to RT-PCR |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity in Relation to the Time Since Symptom Onset in Symptomatic subjects | 15 minutes | Sensitivity of Testing Done Simple Antigen Test according to the days of symptom onset in symptomatic subjects |
Countries
United States
Outcome results
None listed