October 2020—Beckman Coulter launched its Access SARS-CoV-2 Immunoglobulin M assay. The IgM antibody test demonstrated 99.9 percent specificity against 1,400 negative samples, the company reports, and 98.3 percent sensitivity at 15 to 30 days post-symptom onset. The test measures antibodies to the receptor binding domain of the spike protein, which the SARS-CoV-2 virus uses to bind to a human cell receptor.
“Our new SARS-CoV-2 IgM assay provides information about an individual’s immune status with a positive predicative value of 95.5 percent in a population with disease incidence as low as three percent,” Julie Sawyer Montgomery, president of Beckman Coulter, said in a press statement.
The assay runs on a variety of Beckman Coulter analyzers, including the DxI 800, DxI 600, DxC 600i, and Access 2 analyzers, and can be used in random access mode, which means the antibody tests can be run along with other immunoassay tests.
Beckman Coulter, 714-993-5321