Assessing Performance of the Testing Done Simple Covid 19 Antigen Test
Assessing Performance of the Testing Done Simple Covid 19 Antigen Test
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.
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.
Inclusion Criteria:
Subject was given a SARS CoV 2 PCR test for any of the following 4 reasons:
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: