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Beckman Coulter SARS-CoV-2 IgM Antibody Test Receives CE Mark

NEW YORK – Beckman Coulter announced Tuesday its Access SARS-CoV-2 IgM assay received CE marking and will launch in countries accepting the CE mark. 

The quantitative antibody test showed nearly 100 percent specificity with 1,400 negative samples, as well as 98.3 percent sensitivity 15 to 30 days after symptoms began, the company said in a statement. It binds IgM antibodies on the magnetic particle solid phase and uses a recombinant SARS-CoV-2 protein and enzyme conjugate to detect the antibody. 

The test, which received Emergency Use Authorization from the US Food and Drug Administration last month, runs on Beckman's immunoassay analyzers, including the Dxl 800 system that can process 200 samples per hour and the Access 2 tabletop analyzer. It can also be run with other immunoassay platforms. The Danaher subsidiary said it has the capacity to deliver more than 15 million tests each month.  

"Our new SARS-CoV-2 IgM assay provides information about an individual's immune status with a positive predictive value of 95.5 percent in a population with disease incidence as low as 3 percent," said Julie Sawyer Montgomery, president of Brea, California-based Beckman Coulter.

The firm is also developing a SARS-CoV-2 antigen test and a quantitative IgG assay. Its Access SARS-CoV-2 IgG antibody test received CE marking in June. The separate IgM and IgG tests can help determine a patient's immune status to a recent or past infection, helping physicians figure out when the infection occurred. IgM detects antibodies that are thought to emerge earlier in infections and then dissipate, and IgG detects antibodies that are linked to longer-term immune response. Both tests can be used together and can detect antibodies in asymptomatic people, the company said.