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Siemens Healthineers Gains CE Marks for Seasonal Viral Disease Assays

NEW YORK — Siemens Healthineers said Thursday the company has gained CE marking for a pair of combination assays for differentiating infections with SARS-CoV-2, influenza, and, in one of the tests, human respiratory syncytial virus.

The Erlangen, Germany-based company said its PCR-based FTD SARS-CoV-2/FluA/FluB/HRSV Assay combines the Siemens Healthineers FTD SARS-CoV-2 and FTD Flu/HRSV assays into a single test for seasonal respiratory pathogens. The new combination assay is validated for semi-automated molecular testing on the company's Versant kPCR Molecular System, and it preserves the sensitivity of the previous assays through separate detection of SARS-CoV-2 targets.

A second new assay, the Clinitest Rapid COVID-19 + Influenza A/B Antigen Test, uses nasopharyngeal swab specimens collected by a healthcare provider and provides reliable results in 15 minutes without instrumentation or other equipment, Siemens Healthineers said. The test results are 98 percent sensitive and more than 99 percent specific for SARS-CoV-2 virus infections, 89 percent sensitive and 98 percent specific for influenza A infections, and 87 percent sensitive and 98 percent specific for influenza B infections.

"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 for 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."

The CE marks for both assays were received before the In Vitro Diagnostic Regulation went into effect in Europe in May.

Siemens Healthineers gained FDA Emergency Use Authorization this March for a pair of chemiluminescent immunoassays for SARS-CoV-2 viruses and, last year, gained EUA for SARS-CoV-2 antibody tests on the Advia Centaur and Atellica IM instruments.