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Siemens Healthineers Obtains CE Mark for Laboratory-Based, High-Throughput Antigen Test

NEW YORK ─ Siemens Healthineers on Tuesday announced it has obtained CE marking for its laboratory-based SARS-CoV-2 Antigen Assay, called CoV2Ag, making it available in Europe and other regions that accept the designation.

The CoV2Ag assay is CE marked for the qualitative detection of SARS-CoV-2 in nasopharyngeal swab and nasal swab specimens within the first seven days of symptom onset, or from asymptomatic individuals. It is for use with the firm's Atellica IM Analyzer, Adiva Centaur XP system, or Advia Centaur XPT immunoassay system, the company said.

Erlangen, Germany-based Siemens Healthineers further added that it has submitted the test to the US Food and Drug Administration for Emergency Use Authorization.

The firm said its CoV2Ag test has a sensitivity exceeding 94 percent and specificity of 100 percent. It detects the nucleocapsid antigen and has been designed with five monoclonal antibodies with the objective of maximizing its sensitivity to both current and future SARS-CoV-2 variants. Further, the antigen assay provides a time to result for lab-based antigen tests that makes it ideal for testing large quantities of patient samples quickly, Siemens Healthineers added.

According to the firm, the test also helps protect laboratory staff from the coronavirus with a pretreatment process that inactivates the virus without compromising the quality or validity of test results.

By running the CoV2Ag assay on the Atellica IM Analyzer, a platform that can run up to 440 tests per hour, laboratories can increase their SARS-CoV-2 testing capacities, the firm added.  Such testing could be deployed at on-site collection centers for hospital staff, patients, and visitors; remote collection facilities for large scale testing of local populations; and pop-up labs at airports or large universities.

Last November, the US Department of Health and Human Services' Biomedical Advanced Research and Development Authority (BARDA) awarded $13 million to Siemens Healthineers for the development of its high-throughput Atellica IM SARS-CoV-2 Antigen (CoV2Ag) Test and Advia Centaur SARS-CoV-2 antibody test.