Oct. 12, 2020—Beckman Coulter announced its Access SARS-CoV-2 immunoglobulin M assay has received emergency use authorization from the FDA. The test detects antibodies that recognize the receptor-binding domain of the spike protein, which the virus uses to enter human host cells. The assay demonstrated 99.9 percent specificity and 98.3 percent sensitivity.
“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,” Julie Sawyer Montgomery, president of Beckman Coulter, said in a press statement. “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.”
The Access SARS-CoV-2 IgM assay can be used in random access mode, which means that the antibody tests can be run along with other immunoassay tests. It can also be used with a variety of Beckman Coulter analyzers, including the DxI 800, the DxI 600, the DxC 600i, and Access 2 analyzers.