Beckman Coulter Gets FDA EUA For Its SARS-CoV-2 IgM Antibody Test - Quick Facts

(RTTNews) - Diagnostics company Beckman Coulter, Inc., a Danaher Corp. (DHR) company, announced Friday that its Access SARS-CoV-2 Immunoglobulin M (IgM) assay has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA).

The assay detects antibodies that recognize the receptor binding domain (RBD) of the spike protein which the SARS-CoV-2 virus uses to enter the human host cells.

The assay, which demonstrates 99.9% specificity and 98.3% sensitivity, is part of a suite of diagnostic solutions being developed by Beckman Coulter in response to the ongoing COVID-19 pandemic to guide physicians and patients in their healthcare decision making.

Beckman Coulter's suite of COVID-19 testing solutions includes the Access SARS-CoV-2 IgM assay and the Access SARS CoV-2 IgG assay, which received EUA in June. It also recently received FDA EUA for its interleukin 6 (IL-6) assay.