Quidel’s QuickVue At-Home COVID-19 Test Earns EUA

Quidel Corporation has obtained Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA), for its new QuickVue At-Home COVID-19 Test, which qualitatively detects the SARS-CoV-2 nucleocapsid protein antigen. It’s 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 symptom onset. This test is also authorized for prescription home use with adult-collected anterior NS samples directly from individuals aged 8 years or older suspected of COVID-19 within the first six days of the onset of symptoms.
 
The QuickVue At-Home COVID-19 Test will allow patients with a prescription to easily perform the test themselves and get results in 10 minutes. The test shows positive results agreeing with PCR 84.8 percent of the time, and negative results agreeing 99.1 percent of the time.
 
“Quidel’s employees have truly risen to the challenge of the SARS pandemic. Our mission is to provide greater access to frequent, affordable and highly 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,” Quidel president and CEO Douglas Bryant told the press. “This is an important first step in a two-step process that, once additional ongoing studies are completed, will further expand access to frequent testing at home.”
 
The QuickVue At-Home COVID-19 Test uses the lateral flow technology used for decades and features the same SARS CoV-2 rapid antigen test strip and reagent solution that gained EUA in December 2020. Quidel’s contract with the National Institutes of Health’s Rapid Acceleration of Diagnostics initiative was expanded in late 2020 to include the QuickVue At-Home COVID-19 test, expediting its EUA.
 
Quidel recently started buildout of a new manufacturing facility in Carlsbad, Calif. 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, or 600 million tests per year at full capacity.
 
“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,” Bryant noted. “We hope to bring the benefits of this technology to more broadly serve consumers, school systems, businesses and remote communities in the near future.”
 
The QuickVue platform in visually diagnoses Influenza, respiratory syncytial virus, Strep A, and a variety of other illnesses. Since launch, over 150 million QuickVue diagnostic tests have been sold.