CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
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.
The test has a confirmed 100 percent negative percent agreement and a 98.9 percent positive percent agreement at greater than or equal to 15 days post symptom onset. The assay can be used in random access mode and integrates into existing workflows without batch processing. Results of the test are delivered on Beckman Coulter’s immunoassay analyzers, including the DxI 800 high-throughput analyzer, which can process up to 4,800 samples per day.