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Siemens Healthineers Gets FDA Emergency Use Authorization for SARS-CoV-2 Antigen Tests

NEW YORK — The US Food and Drug Administration last week granted separate Emergency Use Authorizations for two SARS-CoV-2 antigen tests developed by Siemens Healthineers.

The Atellica IM SARS-CoV-2 Antigen and the Advia Centaur SARS-CoV-2 Antigen are both chemiluminescent immunoassays designed to detect viral nucleocapsid antigen in anterior nasal swab specimens collected in Siemens Healthineers Sample Inactivation Media.

The Atellica test runs on Siemen's Atellica IM Analyzer, while the Advia Centaur test runs on the Erlangen, Germany-based company's Advia Centaur XPT systems.

Both tests are authorized for use only by labs CLIA-certified to perform moderate- or high-complexity tests, according to the FDA.

Last year, Siemens received EUAs from the FDA for SARS-CoV-2 antibody tests that run on the Advia Centaur and Atellica IM instruments.