Beckman Coulter Receives FDA EUA for COVID-19 IgG Antibody Test
The FDA has granted Beckman Coulter Emergency Use Authorization (EUA) for its Access SARS-CoV-2 IgG II antibody assay.
The semi-quantitative assay measures the level of antibodies a patient has produced in response to a prior SARS-CoV-2 infection, providing a qualitative and a numerical result. It can be used to monitor patient recovery and gauge how their immune response to COVID-19 is affected over time, the company said.
The test, which has also been cleared in Europe, is run on the company’s immunoassay analyzers, including its DxI 800 system, which can process up to 4,800 samples daily.