Siemens Healthineers obtained FDA emergency use authorization for SARS-CoV-2 antibody testing

New York-Last week, the US Food and Drug Administration granted emergency use authorization to Siemens Healthineers for its Advia Centaur SARS-CoV-2 IgG or sCOVG test.
Chemiluminescence immunoassay is designed for qualitative and semi-quantitative detection of immunoglobulin G or IgG against SARS-CoV-2 in serum and plasma. The test is run on Siemens’ Advia Centaur XP, Advia Centaur XPT and Advia Centaur CP immunoassay systems.
According to the FDA, this test can be used by any CLIA-accredited laboratory to perform moderate or highly complex tests.
In March of this year, the SARS-CoV-2 IgG immunoassay run by Siemens, headquartered in Erlangen, Germany, on its Atellica IM analyzer, won the FDA’s EUA.
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Post time: Jul-21-2021