Assessing Performance of the Testing Done Simple Covid 19 Antigen 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 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