On Mar. 31, 2021, Quidel announced that it had received an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA),, allowing the company to market its new 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 was authorized for nonprescription home use with self-collected direct anterior nares 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, delivering confidence to patients running the test and facilitating informed discussions with doctors. 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. Routine testing by rapid antigen tests has shown to be effective in diagnosing COVID-19.