Feinglass, M.D., MPH, chief medical officer Beckman Coulter. “Having a clearer picture of the immune response to SARS-CoV-2 plays an important role in the fight against COVID-19, especially before a vaccine is widely available,” said Shamiram R. Beckman Coulter is also planning to make the assay available to markets accepting the CE Mark before the end of the year. Food and Drug Administration (FDA) and will immediately begin shipping assays to its customer base throughout the U.S. The organization is filing for Emergency Use Authorization of the assay with the U.S. The assay may also help researchers as they begin to understand the levels of IgG antibodies needed to be considered protective. The new capabilities of this assay enable clinicians to establish a baseline to evaluate an individual’s immune response to the SARS-CoV-2 virus based on a numerical value and assess relative changes of an individual’s immune response to the virus over time. 23, 2020 -Beckman Coulter, a clinical diagnostics leader, today launched its Access SARS-CoV-2 IgG II assay that measures a patient’s relative level of antibodies in response to a previous SARS-CoV-2 infection. Access SARS-CoV-2 IgG II test is a semi-quantitative assay that measures patient’s relative level of antibodies in response to a previous SARS-CoV-2 infectionĪssay is an added tool to assess relative changes of IgG levels over time to demonstrate the durability of an immune response to the SARS-CoV-2 virusīREA, CALIF., Nov.
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