FDA Grants Emergency Authorization to Quidel’s At-Home COVID-19 Test

Quidel Corporation has received an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its new QuickVue At-Home OTC COVID-19 test. The assaiy can detect nucleocapsid protein antigens 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.

“Quidel and the people we serve through our advanced diagnostic technologies all owe a debt of gratitude to the FDA, CDC and NIH for their tireless and thorough pursuit of the science and the algorithms to guide accurate and equitable COVID-19 testing protocols that will catch infections early and help contain virus spread,” said Douglas Bryant, president and CEO of Quidel Corporation. “Studies are confirming that serial testing with rapid antigen tests is a crucial resource for people to know their current health status and make prudent decisions to protect themselves, their loved ones and their communities.”

The QuickVue At-Home OTC test is authorized for nonprescription home use with self-collected (unobserved) direct anterior nares (NS) 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 test shows excellent performance, with positive results agreeing with PCR 83.5 percent of the time, and negative results agreeing 99.2 percent 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-19.¹
  
The QuickVue At-Home OTC test employs the same Quidel 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.
 
Quidel’s QuickVue brand launched in 1986 with visually read rapid diagnostics focusing on women’s health and respiratory diseases. In 1999, QuickVue Influenza A+B was the first visually read rapid test approved by the FDA for professional use. QuickVue was also the first flu test cleared by the FDA for use in CLIA-Waived point-of-care facilities like doctors’ offices, urgent care clinics and pharmacies. Today, QuickVue is a market-leading platform in the professional segment for visually diagnosing Influenza, respiratory syncytial virus, Strep A and a variety of other illnesses. Since the launch of the QuickVue brand into the professional segment, more than 150 million QuickVue diagnostic tests have been sold.
 
Quidel recently started the 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.

Reference
¹ https://www.medrxiv.org/content/10.1101/2021.03.19.21253964v2