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Siemens Healthineers Gets FDA Emergency Use Authorization for SARS-CoV-2 Antibody Test

NEW YORK — The US Food and Drug Administration last week granted Emergency Use Authorization to Siemens Healthineers for its Advia Centaur SARS-CoV-2 IgG, or sCOVG, test.

The chemiluminescent immunoassay is designed for the qualitative and semi-quantitative detection of immunoglobulin G, or IgG, against SARS-CoV-2 in serum and plasma. The test runs on Siemens' Advia Centaur XP, Advia Centaur XPT, and Advia Centaur CP immunoassay systems.

The test may be used by any lab CLIA-certified to perform moderate- or high-complexity tests, according to the FDA.

In March, Erlangen, Germany-based Siemens received FDA EUA for a SARS-CoV-2 IgG immunoassay that runs on its Atellica IM Analyzer.