Quidel’s QuickVue At-Home OTC COVID-19 Test Gets EUA

Quidel has received an Emergency Use Authorization (EUA) from the FDA for its QuickVue At-Home over-the-counter (OTC) COVID-19 Test.

The test can detect the presence of nucleocapsid protein antigen from the SARS-CoV-2 virus and can deliver results in 10 minutes, according to the company.

Samples for the immunoassay come from self-collected nasal swabs by people age 14 and up with symptoms of COVID-19 within the first six days of symptom onset. They may also be collected with adult help from children age two to 13.

The rapid home test is intended to be used twice over two to three days, with at least 24 hours and no more than 36 hours between tests.