In response to the global COVID-19 pandemic, Beckman Coulter is developing assays to identify IgM and IgG antibodies to the coronavirus or SARS-CoV-2. The assays will be designed for use on any of its high-throughput Access family of immunoassay systems, including the Access 2 and DxI series installed globally.

Research has shown that after infection with SARS-CoV-2, viral antigens stimulate the body's immune system to produce antibodies that can be detected with IgM and IgG tests. "Antibody assays play a critical role in understanding the measure of immunity an individual has developed against SARS-CoV-2," said Kathleen Orland, senior vice president and general manager for Beckman Coulter's chemistry and immunoassay business. "This type of understanding could help determine the identification of those who would require a vaccine once available or when an infected individual could safely return to work."

"With the ability to assess a patient's immunity to SARS-CoV-2, this testing modality may enable clinicians to clear hospital staff, emergency responders, and others to get back to work with an indication that have had prior exposure and therefore may have immunity to the disease," said Shamiram R. Feinglass, M.D., MPH, chief medical officer, Beckman Coulter. "This test also could allow those without immunity to be identified and kept safe until the pandemic subsides."

Once the assays are finalized, Beckman Coulter intends to follow FDA's Emergency Use Notification process as provided in the FDA's Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency.

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