This 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
Quidel’s QuickVue at-home OTC Covid-19 test receives emergency use authorisation for screening use with serial testing. (Credit: Gerd Altmann from Pixabay)
Quidel Corporation (NASDAQ: QDEL) (“Quidel”), a leading provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced today that it has received an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA), allowing the company to market its new QuickVue At-Home OTC COVID-19 Test for the qualitative detection of the nucleocapsid protein antigen 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.
This 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 COVID-19 Test shows excellent performance, with positive results agreeing with PCR 83.5% of the time, and negative results agreeing 99.2% 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
“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 COVID-19 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, 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, or 600 million tests per year at full capacity.
The QuickVue® At-Home OTC COVID-19 Test is only for use under the Food and Drug Administration’s Emergency Use Authorization. The QuickVue® At-Home OTC COVID-19 Test has not been FDA cleared or approved. The test has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens, and is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
Source: Company Press Release