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U.S. Department of Health and Human Services

Siemens Healthineers – Atellica® IM SARS-CoV-2 Total (COV2T) Assay

The SARS-CoV-2 Total (COV2T) assay is a chemiluminescent immunoassay intended for qualitative detection of total antibodies (including IgG and IgM) to SARS-CoV-2 in human serum and plasma (EDTA and lithium heparin) using the Atellica® IM system. Siemens has over 2,000 fully automated immunoassay analyzers in hospitals and mid- to high-volume reference laboratories across all 50 states. The analyzers include the Atellica® IM which can run up to 440 tests/hour ith result in 10 minutes and the ADVIA Centaur® XP & XPT analyzers, which can test up to 240 samples/hour with result in 18 minutes.

Emergency Use Authorization

On July 31, 2020, FDA issued an Emergency Use Authorization (EUA) to allow Siemens Healthineers’ Atellica ®  IM SARS-CoV-2 Total (COV2T) assay to be used to identify individuals with an adaptive immune response to SARS-CoV-2, indicating prior or recent infection.

  • This page last reviewed: October 26, 2020