Assay 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 virus
BREA, CALIF., Nov. 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. 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. The assay may also help researchers as they begin to understand the levels of IgG antibodies needed to be considered protective.2
The organization is filing for Emergency Use Authorization of the assay with the U.S. Food and Drug Administration (FDA) and will immediately begin shipping assays to its customer base throughout the U.S. under Policy D. Beckman Coulter is also planning to make the assay available to markets accepting the CE Mark before the end of the year.
“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. Feinglass, M.D., MPH, chief medical officer Beckman Coulter. “While it's unknown how long antibodies persist following infection, and if the presence of antibodies confers protective immunity, having a quantifiable baseline is a critical step towards furthering the understanding of the adaptive immune response to SARS-CoV-2 in individuals over time.”
Access SARS-CoV-2 IgG II semi-quantitative assay provides a numerical result in Arbitrary Units (AU) from 2.00- 450 AU/mL1 as well as a qualitative result and offers the same high level of quality as Beckman Coulter’s Access SARS-CoV-2 IgG and IgM serology tests already on the market. The assays use the receptor-binding domain (RBD) of the spike protein. Beckman Coulter selected the RBD of the spike protein as it is critical for viral entry into human cells and has been shown to be the target for neutralizing antibodies in a surrogate model. This selection is also aligned with the multiple vaccines in development that target or include the RBD of the spike protein, with the goal of producing protective antibodies.
The Access SARS-CoV-2 IgG II semi-quantitative assay is the latest addition to Beckman Coulter’s full suite of testing solutions designed to provide valuable information to clinicians in their fight against COVID-19. The next product expected from the organization is an automated SARS-CoV-2 antigen test which is currently under development. While point of care (POC) antigen tests have a purpose in diagnosing COVID-19, they are difficult and resource intensive to scale to address high volume testing needs3. Beckman Coulter’s antigen test is being designed to provide ultimate flexibility in scaling to address the needs of small, moderately complex laboratories that operate a desktop analyzer, to large laboratories that implement automated, high-throughput analyzers for mass testing.