Beckman Coulter Launches Semi-Quantitative Access SARS-CoV-2 IgG II Antibody Test

The assay’s new capabilities 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.

The 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. The assays use the receptor-binding domain (RBD) of the spike protein. Beckman has 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.

Beckman is filing for Emergency Use Authorization of the assay with the US Food and Drug Administration (FDA) and will immediately begin shipping assays to its customer base throughout the US. The company is also planning to make the assay available to markets accepting the CE Mark before the end of the year. Additionally, Beckman is developing an automated SARS-CoV-2 antigen test 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.

“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.”