Research & Development
Quidel awarded FDA's EUA for prescribed QuickVue At-Home COVID-19 Test with results in ten minutes
2 March 2021 -

Diagnostic solutions company Quidel Corporation (NASDAQ:QDEL) reported on Monday the receipt of an Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) to market its new QuickVue At-Home COVID-19 Test for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2.

The company added that the test is authorized for prescription home use with self-collected (unobserved) anterior nares (NS) swab specimens directly from individuals aged 14 years and older who are suspected of COVID-19 as well as for prescription home use with adult-collected anterior NS samples directly from individuals aged eight years or older who are suspected of COVID-19.

According to the company, the QuickVue At-Home COVID-19 Test will allow patients with a prescription to easily perform the test themselves and get results in ten minutes. The COVID-19 Test has positive results agreeing with PCR 84.8% of the time and negative results agreeing 99.1% of the time, delivering confidence to patients running the test and facilitating informed discussions with doctors.

Additionally, the company's QuickVue At-Home COVID-19 Test has the same Quidel lateral flow technology and features the same SARS CoV-2 rapid antigen test strip and reagent solution that received the US FDA's EUA for use in professional settings in December 2020.

Based in Carlsbad, CA, the company's 128,000 square foot facility is expected to be the highest-volume production facility and begin operations in the second half of 2021 to produce more than 50m QuickVue rapid antigen tests per month or 600 million tests per year.