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  4. Siemens Healthineers Announces CE-Mark for CLINITEST Rapid COVID-19 Antigen Self-Test for Unsupervised Self Testing
Press release

Siemens Healthineers Announces CE-Mark for CLINITEST Rapid COVID-19 Antigen Self-Test for Unsupervised Self Testing

Published on May 4, 2021

Not for publication in the USA 

  • The CLINITEST Rapid COVID-19 Antigen Self-Test can be used by laypersons 12 and older, with or without symptoms, to detect the SARS-CoV-2 virus.
  • Rapid antigen testing provides individuals with results in just 15 minutes in any setting, including the comfort of their homes. This information can help reduce the risk of exposure for families, schools, and communities.
  • Siemens Healthineers is among the first to supply a COVID-19 test for home use.

Siemens Healthineers announced today the CLINITEST Rapid COVID-19 Antigen Self-Test1 received CE Mark certification for unsupervised self-testing by laypersons 12 and older, including at-home testing. The nasal swab test can be used for symptomatic or asymptomatic self-testing. For children younger than 12 years, the samples must be collected by or under supervision of an adult. The CLINITEST Rapid COVID-19 Antigen Self-Test is available in packs of one test, five tests, and 20 tests. Additionally, two configurations of the five and 20 test packages are available: a multi-use test buffer bottle, or tubes pre-filled with the test buffer solution for added convenience depending on the environment in which the test will be used.

“The CLINITEST Rapid COVID-19 Antigen Self-Test is the among the first CE-marked tests for home use, making information about a possible infection with COVID-19 more widely available without long wait times. Siemens Healthineers has been able to offer a variety of high-quality tests to address all COVID-19 testing needs and this option makes testing even more convenient for a greater number of people," said Christoph Pedain, Head of Point of Care Diagnostics at Siemens Healthineers.

The CLINITEST Rapid COVID-19 Antigen Self-Test has a sensitivity of 97.25 percent and a specificity of 100 percent (compared to a PCR, or nucleic acid-detection method) and provides results in 15 minutes. The simple process for collecting a nasal swab and obtaining a result are included in the Instructions for Use. A nasal swab is collected from both nostrils and then the swab is washed in a buffer to reveal a specific protein inside the SARS-CoV-2 virus. The sample is then dispensed onto the test cassette and after 15 minutes the result is visible. The position and number of lines clearly indicate whether the test is positive or negative.

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Siemens Healthineers 2021

Siemens Healthineers AG (listed in Frankfurt, Germany: SHL) is shaping the future of healthcare. As a leading medical technology company headquartered in Erlangen, Germany, Siemens Healthineers enables healthcare providers worldwide through its regional companies to increase value by empowering them on their journey towards expanding precision medicine, transforming care delivery, improving the patient experience, and digitalizing healthcare. Siemens Healthineers 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 to patients. In fiscal 2020, which ended on September 30, 2020, Siemens Healthineers generated revenue of €14.5 billion and adjusted EBIT of €2.2 billion. Following the acquisition of Varian Medical Systems, Inc. the company has approximately 66,000 employees worldwide. Further information is available at www.siemens-healthineers.com.