Beckman Coulter Develops Tests to Detect Coronavirus Antibodies
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In response to the global COVID-19 pandemic, Beckman Coulter, a company specializing in clinical diagnostics, has announced that it is developing assays to identify IgM and IgG antibodies to SARS-CoV-2. 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.
The assays will be designed for use on any of Beckman Coulter’s high-throughput Access family of immunoassay systems, including the Access 2 and DxI series, which can be found worldwide. “Antibody assays play a critical role in understanding the level 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 identify 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 they have had prior exposure and therefore have built an immunity to the disease,” said Shamiram R. Feinglass, MD, MPH, Chief Medical Officer, Beckman Coulter. “This test could allow those without immunity to be identified and kept safe until the pandemic subsides.”
Beckman Coulter operates within the Danaher Corporation, together with a collection of the world’s leading Diagnostic companies, all on the front line in the fight against coronavirus.
Once the assays are finalized, Beckman Coulter intends to achieve CE mark certification and 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 (March 16, 2020).