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# Beckman EUA for Covid Immunoglobulin Assay
- URL: https://www.fdaweb.com/beckman-eua-for-covid-immunoglobulin-assay/
- Published: 2020-10-09T12:00:00.000Z
- Updated: 2026-09-14T16:32:02.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5147843

FDA has granted Beckman Coulter an emergency use authorization for its [Access SARS-CoV-2 Immunoglobulin M (IgM) assay](https://c212.net/c/link/?t=0&l=en&o=2945090-1&h=385099673&u=https%3A%2F%2Fwww.beckmancoulter.com%2Fen%2Fsolutions%2Fsars-cov-2-antibody-testing&a=%C2%A0Access+SARS-CoV-2+Immunoglobulin+M+%28IgM%29+assay&ref=fdaweb.com). The test detects antibodies that recognize the receptor binding domain of the spike protein which the Covid-19 virus uses to enter the human host cells, the company says. The qualitative immunoassay has confirmed 98.3% positive percent agreement (sensitivity) at 15-30 days post symptom onset and 99.9% negative percent agreement (specificity), it says. It can be used in random access mode and can be run along with other immunoassay tests on a variety of Beckman Coulter analyzers.