COVID-19 Test At Home Efficacy Sub-Study

Background: This was a sub-study of the COVID-19 Test At Home Study. The objective was to gather data on the performance of the Quidel QuickVue test for detection of SARS-CoV-2. The sub-study was designed to provide data to Quidel to supplement their existing Emergency Use Authorization (EUA) application for an at-home test.

Materials/Methods: Asymptomatic participants with close contact to someone positive for SARS-CoV-2 within the past seven days self-administered a Quidel QuickVue test and received a comparator PCR test at the study site on day 1. They were then given kits to perform daily QuickVue tests at home for five consecutive days, with a second PCR test on day 2, and a final PCR on day 6. If a home test between days 3-5 was positive or if symptoms developed with earlier negative PCR results, participants returned for an additional PCR before day 6. Those unable to return on day 6 had up to two extra days, with additional at-home testing required depending on the return day. The primary objective was to assess positive and negative percent agreement of QuickVue compared to PCR in unsupervised use at the site, while secondary objectives assessed at-home performance and compared participant versus staff interpretation of results.

Outcome/Impact: The intended outcome of this sub-study was to generate data on the performance of the Quidel QuickVue test in both supervised and unsupervised at-home use. These data were provided to support Quidel’s EUA application and to evaluate the accuracy of participant interpretation compared to staff assessment.