Beckman Coulter's SARS-CoV-2 IgG II Antibody Test Receives FDA Emergency Use Authorization

Beckman Coulter’s (Brea, CA, USA) Access SARS-CoV-2 IgG II antibody assay received US Emergency Use Authorization (EUA) from the US Food and Drug Administration.

The semi-quantitative assay measures a patient's level of antibodies in response to a previous SARS-CoV-2 infection and provides a qualitative and numerical result of antibodies in arbitrary units (AU). The Access SARS-CoV-2 IgG II assay measures IgG antibodies directed to the receptor-binding domain of the spike protein of the coronavirus. The test has a confirmed 100% negative percent agreement (specificity) and a 98.9% positive percent agreement (sensitivity) at >/= 15 days post symptom onset. The Access SARS-CoV-2 IgG II assay can be used in Random Access Mode (RAM) and seamlessly integrates into existing workflows without batch processing. The Access SARS-CoV-2 IgG II antibody assay is now available in the US and countries accepting the CE Mark. Results of the new test are delivered on Beckman Coulter's immunoassay analyzers, including the DxI 800 high-throughput analyzer, capable of processing up to 4,800 samples per day.

"Effective and high-quality diagnostic solutions are essential in the fight against COVID-19," said Shamiram R. Feinglass, MD, M.P.H, chief medical officer at Beckman Coulter. "Antibody assays like our Access SARS-CoV-2 IgG II test can help researchers quantitatively determine the levels of IgG antibodies and enable them to assess the relative changes of an individual's immune response to the SARS-CoV-2 virus over time. This information is essential because it helps continually inform therapeutics and vaccine development."