Assessing Performance of the Testing Done Simple Covid 19 Antigen Test

Study Overview
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Brief Summary
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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
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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.

Official Title
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Assessing Performance of the Testing Done Simple Covid 19 Antigen Test

Conditions
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COVID-19

Intervention / Treatment
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* Diagnostic Test: Testing Done Simple SARS CoV-2 Antigen Test


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Testing Done Simple Antigen test in Symptomatic Subjects (Nasal swab)<br> | Diagnostic Test: Testing Done Simple SARS CoV-2 Antigen Test<br>* 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.<br>|
| Testing Done Simple Antigen test in Asymptomatic Subjects (Nasal swab)<br> | Diagnostic Test: Testing Done Simple SARS CoV-2 Antigen Test<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity | Sensitivity (True Positive Rate) of Testing Done Simple Antigen Test compared to RT-PCR | 15 minutes | 
| Specificity | Specificity (True Negative Rate) of Testing Done Simple Antigen Test compared to RT-PCR | 15 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity in Relation to the Time Since Symptom Onset in Symptomatic subjects | Sensitivity of Testing Done Simple Antigen Test according to the days of symptom onset in symptomatic subjects | 15 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Antigen test, Test, Diagnosis