The Access SARS-CoV-2 Immunoglobulin M (IgM) assay from Beckman Coulter has received Emergency Use Authorization (EUA) from the US FDA. The assay detects antibodies that recognize the receptor binding domain (RBD) of the spike protein that 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. This assay joins the Access SARS CoV-2 IgG assay, which received EUA earlier this year. Both of these COVID-19 assays are available in automated or high-throughput immunoassay formats, and can easily integrate into laboratory workflows, enabling their addition to routine blood tests performed during inpatient and wellness testing.
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