The QuickVue® At-Home OTC COVID-19 Test for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 from individuals with or without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over two (or three days) with at least 24 hours (and no more than 36 hours) between tests. This test is authorized for nonprescription home use with self-collected (unobserved) direct anterior nares (NS) specimens from individuals aged 14 years and older or with adult-collected anterior NS samples from individuals aged 2 years or older. The QuickVue® At-Home OTC COVID-19 Test shows excellent performance, with positive results agreeing with PCR 83.5% of the time, and negative results agreeing 99.2% of the time. This EUA allows the QuickVue® At-Home OTC COVID-19 Test to be used among asymptomatic individuals and run without a prescription provided that individuals test twice within 24-36 hours. Additional information regarding the intended use of the QuickVue® At-Home OTC COVID-19 Test can be found at www.quidel.com.