NEW YORK — The US Food and Drug Administration on Tuesday granted Emergency Use Authorization for Siemens Healthineers' Atellica IM SARS-CoV-2 IgG (sCOVG) antibody test.
The chemiluminescent immunoassay is designed to detect immunoglobulin G against SARS-CoV-2 in serum and plasma samples. It runs on the Erlangen, Germany-based company's Atellica IM Analyzer.
The test may be used by laboratories CLIA-certified to perform moderate- or high-complexity tests, according to the FDA.
Earlier this year, Siemens received FDA EUAs for two other SARS-CoV-2 IgG detection assays, the Dimension Vista SARS‑CoV‑2 IgG (COV2G) and the Dimension EXL SARS‑CoV‑2 IgG (CV2G).