Assessing Performance of the Testing Done Simple Covid 19 Antigen Test
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 171
- Locations
- 2
- Primary Endpoint
- Sensitivity
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subject was given a SARS CoV 2 PCR test for any of the following 4 reasons:
- •Subject has Covid like symptoms that started within past (7) days
- •Subject has been exposed to another individual with a known Covid diagnosis or probable Covid diagnosis
- •Subject needs Covid test done for travel, school, work, etc
- •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
Outcomes
Primary Outcomes
Sensitivity
Time Frame: 15 minutes
Sensitivity (True Positive Rate) of Testing Done Simple Antigen Test compared to RT-PCR
Specificity
Time Frame: 15 minutes
Specificity (True Negative Rate) of Testing Done Simple Antigen Test compared to RT-PCR
Secondary Outcomes
- Sensitivity in Relation to the Time Since Symptom Onset in Symptomatic subjects(15 minutes)