Siemens Secures New FDA Emergency Use Authorizations for Coronavirus Antibody Test

By HospiMedica International staff writers
Posted on 11 Jun 2020

Siemens Healthineers (Erlangen, Germany) has been granted Emergency Use Authorizations (EUAs) by the US Food and Drug Administration (FDA) for its total antibody test to detect the presence of SARS-CoV-2 antibodies running on the company’s Dimension Vista and Dimension EXL analyzers.

The FDA has granted EUA to Siemens’ Dimension Vista SARS-CoV-2 total antibody assay and Dimension EXL SARS-CoV-2 total antibody assay in order to identify people with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. Both the products are sandwich-based chemiluminescent immunoassays.

Image: COVID-19 Total Antibody Test and Molecular Test Kit (Photo courtesy of Siemens Healthineers)

Siemens had been developing the total antibody assay for use on its Dimension analyzers as well as on the company’s Advia Centaur and Atellica analyzers. Siemens had secured two EUAs for its laboratory-based total antibody test in May – one for use on the company’s Advia Centaur XP and Advia Centaur XPT systems, and the second for use on its Atellica next-generation system.