Beckman Coulter antibody tests receives FDA EUA

March 31, 2021

Beckman Coulter announced that its Access SARS-CoV-2 IgG II antibody assay received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA), according to a news release.

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.

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