Quidel gains Emergency Use Authorization for Covid-19 test

04 Mar 2021

QuickVue At-Home test works using fluorescence and optics system; provides results in ten minutes.

Quidel, a developer of rapid diagnostic testing solutions, has received an Emergency Use Authorization from the U.S. Food and Drug Administration, allowing the company to market its new QuickVue At-Home Covid-19 Test for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2.

This test is authorized for prescription home use with self-collected nasal swab specimens directly from individuals aged 14 years and older who are suspected of Covid-19 by their healthcare provider within the first six days of the onset of symptoms.

The test is also authorized for prescription home use with adult-collected anterior NS samples directly from individuals aged 8 years or older who are suspected of having contracted Covid-19 by their healthcare provider within the first six days of the onset of symptoms.

Quidel has provided rapid Covid-19 testing through doctors and health care providers throughout the pandemic, manufacturing and shipping millions of Sofia tests during 2020.

The test will allow patients with a prescription to perform the test themselves and obtain results in 10 minutes. It shows “excellent performance”, says Quidel, with positive results agreeing with PCR 84.8% of the time, and negative results agreeing 99.1% of the time.

“Quidel’s mission is to provide greater access to frequent, affordable and accurate diagnostic testing, and ultimately to enable individuals to take charge of their own health and help them make prudent decisions to protect themselves and their loved ones,” commented Douglas Bryant, president and CEO of Quidel.

New manufacturing facility

The QuickVue test employs the same lateral flow technology used for decades by healthcare professionals and features the same SARS CoV-2 rapid antigen test strip and reagent solution that received an EUA from the FDA for use in professional settings in December 2020.

The company recently started the buildout of a new manufacturing facility in Carlsbad, CA. The 128,000 square foot facility is expected to be the company’s highest-volume production facility and begin operations in the second half of 2021, initially with a mission to produce more than 50 million QuickVue rapid antigen tests per month.

“The flexibility of our QuickVue At-Home Covid-19 Test for meeting the urgent testing needs of individuals at home will save time and enable doctors and telemedicine providers to determine appropriate treatments without exposing their staff and other patients to heightened risk of infection,” concluded Bryant.