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Press release

Siemens Healthineers announces two new combination tests for both SARS-CoV-2 and other seasonal respiratory pathogens

Published on September 15, 2022

Not for publication in the USA

  • The FTD SARS-CoV-2/FluA/FluB/HRSV1 PCR test enables comprehensive, semi-automated, mid- to high-throughput testing for common and potentially serious seasonal respiratory pathogens.
  • For point-of-care applications, the CLINITEST Rapid COVID-19 + Influenza Antigen Test delivers reliable results in 15 minutes to detect both SARS-CoV-2 and influenza to enable effective and timely management of these viral illnesses.
  • Both tests enable effective management of seasonal respiratory testing during, and beyond, the current COVID-19 pandemic.

Siemens Healthineers announced today the release of its new CE-marked FTD SARS-CoV-2/FluA/FluB/HRSV Assay, a PCR test, and the CLINITEST Rapid COVID-19 + Influenza Antigen Test.1,2

FTD SARS-CoV-2/FluA/FluB/HRSV combination PCR test

Validated on the company’s VERSANT kPCR Molecular System, the kit combines Siemens Healthineers FTD SARS-CoV-23 and FTD Flu/HRSV Assays.1 The new FTD SARS-CoV-2/FluA/FluB/HRSV Assay enables comprehensive and semi-automated molecular testing for seasonal respiratory pathogens. The combination PCR test detects and differentiates between clinically relevant viruses: SARS-CoV-2, Influenza A, Influenza B, and HRSV A/B. Preserving sensitivity via the separate detection of SARS-CoV-2 targets allows the company’s highly effective, proven FTD SARS-CoV-2 Assay to perform without any compromise to sensitivity, maintaining key features of the top-performing assay.

CLINITEST Rapid COVID-19 + Influenza A/B Antigen Test

This convenient 3-in-1 test, administered by a healthcare professional in virtually any medical setting, provides reliable results in 15 minutes. With no instrumentation or equipment required, a single nasopharyngeal swab sample can differentiate between SARS-CoV-2, Influenza A, and Influenza B infections. This test provides high sensitivity and specificity (98.32%/99.60% for SARS-CoV-2, 88.57%/97.78% for Flu A, and 87.10%/97.87% for Flu B). Results can facilitate prompt self-isolation of infected patients, if deemed necessary, to prevent the spread of SARS-CoV-2 and influenza.

"As we enter cold and flu season, PCR and antigen testing options will allow clinicians to improve patient care by helping to identify the cause of respiratory illnesses that often present with similar symptoms,” said Sharon Bracken, Head of Diagnostics, Siemens Healthineers. "Enabling healthcare professionals to identify and differentiate among these infections in an efficient and timely manner may help to reduce the spread of seasonal respiratory viruses and SARS-CoV-2."

For more information on the FTD SARS-CoV-2/FluA/FluB/HRSV Assay and the CLINITEST Rapid COVID-19 + Influenza A/B Antigen Test, visit https://www.siemens-healthineers.com/clinical-specialities/critical-care/covid-19-respiratory-testing.

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1

Not available for sale in the U.S. Product availability may vary by country.

2

CLINITEST and all associated marks are trademarks of Siemens Healthcare Diagnostics Inc., or its affiliates.

3

CE-IVD–labeled for diagnostic use in the EU. This test has not been FDA-cleared or approved. This test has been authorized by FDA under an EUA for use by authorized laboratories. This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. This 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 Act, 21. U.S.C. § 360bbb- 3(b)(1), unless the authorization is terminated or revoked sooner.

Siemens Healthineers 2022

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.