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Beckman Coulter SARS-CoV-2 IgG Antibody Test Gets FDA Emergency Use Authorization

NEW YORK – Danaher subsidiary Beckman Coulter announced on Tuesday that its Access SARS-CoV-2 IgG II antibody test has received Emergency Use Authorization from the US Food and Drug Administration.

The test measures IgG antibodies to SARS-CoV-2 in the receptor-binding domain of the spike protein of the virus from plasma and has demonstrated 99.9 percent specificity and 98.9 percent sensitivity at 15 to 60 days after symptom onset, according to a statement from the company. The semi-quantitative assay provides a qualitative and numerical result of antibodies in arbitrary units.

The test can be used in Random Access Mode, integrating into laboratory workflows without batch processing, the company added. It runs on Beckman's immunoassay analyzers, including its high-throughput UniCel DxI 800 systems. 

SARS-CoV-2 antibody tests "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," Beckman Coulter CMO Shamiram Feinglass said. "This information is essential because it helps continually inform therapeutics and vaccine development." 

The assay has also received CE marking, the company said. Beckman's previous iteration of the test received EUA from the FDA in June.