COVID-19 Test At Home Efficacy Sub-Study

This is a sub-study of the COVID-19 Test At Home Study. The objective is to gather data on performance of Quidel QuickVue for detection of SARS-CoV-2. This sub-study will be used to provide data to Quidel to supplement their existing EUA application for an at-home test. In this study, we will ask asymptomatic participants with known close contact to someone who was positive for SARS-CoV-2 infection within the past seven days to self-administer a Quidel QuickVue test and receive a comparator PCR test at the study site on the first day of the study. Thereafter, participants will receive a test-kit to perform Quidel QuickVue test daily at home, preferably in the morning, for five consecutive days. Participants will be asked to return to the study site on day 2 for a second PCR test and on the final day (study day 6). However, if any of the home-tests from days 3-5 result as positive or participants develop symptoms and their PCR test result was negative on days 1-2, they will be asked to come to the study-site for a comparator PCR test earlier than day 6. Participants will be given two additional days to return to the study site if they are unable to come on day 6 for an exit PCR; for those participants, they will perform an additional Quidel QuickVue test at home before the standard test at the study site. This means that if they come in on day 6, then no at home test will be performed on days 7 and 8. If they come in on day 7 then they perform a test at home on day 7. If they come in on day 8 then they perform a test at home on days 7 and 8.The primary objective of this sub-study will be to evaluate the performance (positive percent agreement and negative percent agreement) of the Quidel QuickVue test when self-administered by participants in an unsupervised setting at the study site in comparison to a comparator PCR test performed the same day by study staff. Secondary objectives of this sub-study will be to: 1) evaluate the performance (positive percent agreement and negative percent agreement) of the Quidel QuickVue test when self-administered by participants at home in comparison to a comparator PCR performed at the beginning and end of the study and 2) Compare self-reported interpretation of QuickVue test result with interpretation made by a study staff in-person (on day 1) and digitally (days 2-6).