Press release

Siemens Healthineers offers lab-based antigen test for high-throughput analyzers and expands COVID-19 test capacities

Published on February 23, 2021

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This test has not been reviewed by the FDA. In the US, use of this test is limited to laboratories that are certified under Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform high-complexity testing. Product availability may vary from country to country and is subject to varying regulatory requirements.


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Based on PCR results obtained from symptomatic and asymptomatic patients with the FTD SARS-CoV-2 PCR method. Percent positive agreement with PCR Ct<30 samples (relative sensitivity) was 96.07%, and percent negative agreement with PCR negative samples (relative specificity) was 100%.

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Dependent upon text mix.

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.