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
Kathleen Orland, senior vice president and general manager for Beckman Coulter’s chemisty and immunoassay business, said: “Antibody assays play a critical role in understanding the level of immunity an individual has developed against SARS-CoV-2. 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.”
Once the assays are finalised, 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.
Shamiram R. Feinglass, chief medical officer, Beckman Coulter, said: “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. This test could allow those without immunity to be identified and kept safe until the pandemic subsides.”