Aug. 26, 2020—Beckman Coulter launched its Access SARS-CoV-2 Immunoglobulin M assay. The 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. It 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. “As COVID-19 outbreaks continue to grow in intensity in many of our communities, highly accurate tests such as this are critical for providing reliable information for both individual health decisions as well as population-based immunity monitoring.”
The assay can be used in random access mode, which means that the antibody tests can be run along with other immunoassay tests, and it runs on a variety of Beckman Coulter analyzers, including the DxI 800, DxI 600, DxC 600i, and Access 2 analyzers.