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The CLINITEST Rapid COVID-19 Antigen Self-Test recently received FDA Emergency Use Authorization.
The test is available and already supporting COVID-19 testing efforts across the country.
The company was selected to provide millions of tests toward the U.S. federal government's program to ship tests directly to households, and is also supplying U.S. state governments, nonprofit organizations, and healthcare institutions.
The CLINITEST Rapid COVID-19 Antigen Self-Test also will be available for direct purchase in stores and online, including on Amazon.com.
TARRYTOWN, N.Y., February 03, 2022--(BUSINESS WIRE)--Siemens Healthineers announced today the CLINITEST® Rapid COVID-19 Antigen Self-Test1,2 is now available in the U.S. to self-test for the SARS-CoV-2 virus. The CLINITEST Rapid COVID-19 Antigen Self-Test uses a simple nasal swab to provide accurate COVID-19 test results (including for both the Omicron and Delta variants) in 15 minutes and comes in a five-test-per-box configuration—convenient for families, group, and/or serial testing needs. The test is approved for unsupervised self-testing by individuals ages 14 and older, and adult-collected samples from individuals ages 2-13, with or without symptoms.
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Siemens Healthineers announced today the CLINITEST® Rapid COVID-19 Antigen Self-Test is now available in the U.S. to self-test for the SARS-CoV-2 virus. The CLINITEST Rapid COVID-19 Antigen Self-Test uses a simple nasal swab to provide accurate COVID-19 test results (including for both the Omicron and Delta variants) in 15 minutes and comes in a five-test-per-box configuration—convenient for families, group, and/or serial testing needs. (Photo: Scott Dalton/AP Images for Siemens Healthineers)
"Siemens Healthineers is bringing millions of rapid COVID-19 antigen tests to the United States to make them available to the American people at a time when the tests are desperately needed," said Jennifer Zinn, Executive Vice President and Head of Diagnostics, North America, Siemens Healthineers. "Since receiving Emergency Use Authorization for the CLINITEST Rapid COVID-19 Antigen Self-Test in December, we’ve worked tirelessly to leverage every pathway to bring the tests to the public as quickly as possible. This is in addition to the tremendous efforts we've successfully undertaken to make these tests widely available in Europe."
On January 24, the company was selected as a test supplier to support the U.S. federal government’s efforts to ship tests directly to households. Siemens Healthineers committed to making tens of millions of tests available for the federal government over the next two months. Additionally, Siemens Healthineers is supplying millions more tests for state government programs and to nonprofit organizations. Siemens Healthineers also is supplying the antigen tests to healthcare institutions across the country to ensure front-line workers can continue to care for patients safely.
"As Americans struggle to access COVID-19 tests amidst the latest surge, we were eager to step in to help workers and students be safe," said Randi Weingarten, President, American Federation of Teachers. "Working with Siemens Healthineers we are helping educators and school staff, as well as nurses and others we represent, get the supplies they need to keep themselves, their families, and their students safe. Rapid tests provide the peace of mind necessary for our nation's schools to remain safely in person—where students do best—without risking the spread of COVID. Pandemic safety remains a community-wide effort, and with this critical inventory and partnership from Siemens Healthineers, we can help get more tests into the hands of people who need them most."
Siemens Healthineers' response to the pandemic
Siemens Healthineers has distinguished itself as a provider of quality diagnostic assays to aid the fight against the COVID-19 pandemic. In addition to antibody, antigen, and molecular SARS-CoV-2 tests, Siemens Healthineers offers a broad diagnostics portfolio across point of care and laboratory applications to aid in the prognosis, treatment, and follow-up care of COVID-19 patients. The company’s broad and differentiated menu includes hematology, coagulation, cardiac, respiratory, inflammation, and infectious disease panels. Blood gas testing and imaging solutions from Siemens Healthineers deliver actionable results that aid clinicians in caring for COVID-19 patients. In addition to the U.S., Siemens Healthineers continues its commitment to deliver quality assays to Europe and other markets worldwide to aid global COVID-19 testing efforts.
The CLINITEST Rapid COVID-19 Antigen Self-Test will be available through national retailers and online. More information about the CLINITEST Rapid COVID-19 Antigen Self-Test, including the most up-to-date information about where to find it, can be found on the company's website here.
1 Product availability varies by country. Distributed by Siemens Healthineers.
2 In the USA, this product has not been FDA cleared or approved; but has been authorized by FDA under an Emergency Use Authorization. This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens. The emergency use of this product 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 the declaration is terminated or authorization is revoked sooner.
Siemens Healthineers AG (listed in Frankfurt, Germany: SHL) pioneers breakthroughs in healthcare. For everyone. Everywhere. As a leading medical technology company headquartered in Erlangen, Germany, Siemens Healthineers and its regional companies is continuously developing its product and service portfolio, with AI-supported applications and digital offerings that play an increasingly important role in the next generation of medical technology. These new applications will enhance the company’s foundation in in-vitro diagnostics, image-guided therapy, in-vivo diagnostics, and innovative cancer care. Siemens Healthineers also provides a range of services and solutions to enhance healthcare providers’ ability to provide high-quality, efficient care. In fiscal 2021, which ended on September 30, 2021, Siemens Healthineers, which has approximately 66,000 employees worldwide, generated revenue of €18.0 billion and adjusted EBIT of €3.1 billion. Further information is available at www.siemens-healthineers.com.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220201006000/en/
Kimberly Nissen, Siemens Healthineers
Phone: +1 610 241-2129; Email: Kimberly.Nissen@siemens-healthineers.com