Industry News: Beckman Coulter SARS-CoV-2 IgM antibody test receives FDA emergency use authorization

13 Oct 2020


Beckman Coulter, a clinical diagnostics leader, has announced 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.

“Since March, the Beckman Coulter team has worked around the clock to develop a suite of assays that play a critical role in the ongoing global fight against COVID-19,” said Julie Sawyer Montgomery, president of Beckman Coulter. “As a science-driven company, we continue in our commitment to deliver rigorously validated diagnostics of the highest quality that provide meaningful information, so doctors and patients alike can trust the results for urgent, care decisions.”

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. The company also recently received FDA Emergency Use Authorization for its interleukin 6 (IL-6) assay, which can be used to assist in identifying severe inflammatory response in patients with confirmed COVID 19 illness to aid in determining the risk of intubation with mechanical ventilation, in conjunction with clinical findings and the results of other laboratory testing. Beckman Coulter is also currently developing a SARS CoV-2 antigen assay as well as a quantitative IgG assay anticipated to be launched later this year.

All of the Beckman Coulter assays to address COVID-19 can be performed in automated or high-throughput immunoassay formats, as well as Beckman Coulter’s Access 2 analyzer, a compact, table-top analyzer enabling high-quality serology testing to be carried out in small hospitals and clinics. Additionally, all of the assays seamlessly integrate into laboratory workflows making it easy to add these tests to routine blood tests performed during inpatient and wellness testing.

For more information on Beckman Coulter’s suite of testing solutions or its commitment to the fight against COVID-19, visit www.BeckmanCoulter.com/Coronavirus.

About the Access SARS-CoV-2 IgM Assay
The Access SARS-CoV-2 IgM Assay is a qualitative immunoassay that detects IgM antibodies. The test has confirmed 98.3% positive percent agreement (sensitivity) at 15-30 days post symptom onset and 99.9% negative percent agreement (specificity). The assay utilizes an immunocapture format to bind patient IgM antibodies on the magnetic particle solid phase and a recombinant SARS-CoV-2 protein - enzyme conjugate to detect anti-SARS-CoV-2 IgM. The Access SARS-CoV-2 IgM assay can be used in Random Access Mode (RAM), which means that the antibody tests can be run along with other immunoassay tests. The assay can also be used with a variety of Beckman Coulter analyzers, including the high-throughput DxI 800 designed for large labs, to the DxI 600 for mid-sized labs and the DxC 600i and Access 2 analyzers for smaller labs and healthcare clinics.

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