FDA authorizes Beckman’s IgG antibody for SARS-CoV-2
June 2021—Beckman Coulter’s Access SARS-CoV-2 IgG II antibody assay received emergency use authorization from the FDA. The semiquantitative 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. It measures IgG antibodies directed to the receptor-binding domain of the spike protein of the coronavirus.