QuickVue antigen test provides fast, accurate results in 10 minutes

FOR IMMEDIATE RELEASE

BROOKLYN, NY (September 7, 2021) — Access to fast, accurate COVID-19 test results is increasing for communities throughout the U.S. with a new addition to the Project N95 online shop. Project N95 – a nonprofit, 501(c)(3) organization – is adding the Quidel QuickVue® At-Home OTC COVID-19 Test to its suite of products. This rapid over-the-counter (OTC) antigen test is available to consumers without a doctor’s prescription and provides results in 10 minutes, all in the privacy of their own homes. Available over-the-counter, everything you need to complete two tests is included in the package and taking the test is simple.

“As the Delta variant spreads and positive cases continue to rise, the availability of at-home testing options for COVID-19 testing is critical,” said Geoff Bonn, chief financial officer of Project N95. “The fact that the Quidel test provides results in 10 minutes and includes two tests in each box makes fast, accurate and affordable testing available to everyone, everywhere.”

The QuickVue At-Home OTC COVID-19 Test is available over-the-counter and includes everything needed to complete the test in the package. The QuickVue At-Home OTC COVID-19 Test is intended 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 home test is authorized for nonprescription home use with self-collected (unobserved) direct anterior nasal (NS) swab specimens from individuals aged 14 years and older or with adult-collected anterior NS samples from individuals aged 2 years or older. This rapid, convenient solution is available from the Project N95 Shop in a single count or 25-count purchase.

Since launching in 2020, Project N95 has provided more than 9.1 million units of personal protective equipment (PPE) to healthcare workers throughout the United States. This led to the protection of hundreds of thousands of workers in hospitals, long-term care facilities, and other healthcare centers during the COVID-19 pandemic. After adding COVID-19 test kits to its product offerings in early 2021, the organization has continued to innovate to open access and provide critical equipment where it is needed most.

As mission-driven nonprofit, Project N95 makes it possible for everyone to access personal protective equipment and COVID-19 tests from a trusted source. To find the QuickVue At-Home OTC COVID-19 test and other critical supplies such as N95 respirators, surgical masks and COVID-19 tests, visit the Project N95 shop.

This home test has not been FDA cleared or approved but has been authorized by the FDA under an Emergency Use Authorization (EUA) for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens. This home test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics 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 authorization is terminated or revoked sooner.

About Project N95 Project N95 protects communities and the people who live and work in them by providing equitable access to the resources they need to stay safe through the COVID-19 pandemic. As a leading rapid response nonprofit organization created in response to the pandemic, Project N95 has delivered more than 8.4 million units of personal protective equipment since May 2020, becoming the national clearinghouse for critical PPE and diagnostic tests. Visit projectn95.org to learn more or to volunteer.

Project N95 Press contact: press@projectn95.org