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Danaher Beckman Coulter Unit to Ship New SARS-CoV-2 Antibody Test

August 24, 2020

Danaher Corp.’s Beckman Coulter division Monday said it would begin shipping its Access SARS-CoV-2 Immunoglobulin M antibody test to U.S. diagnostics labs.

The new test demonstrated 99.9% specificity against 1,400 negative samples and 98.3% sensitivity at 15 to 30 days after the onset of symptoms, Beckman Coulter said.

The company said its test targets antibodies that recognize the receptor binding domain of the spike protein that SARS-CoV-2 uses to bind to a human cell receptor. This is significant as antibodies that target the RBD have the potential to be neutralizing and thus prevent future infection by blocking the virus from entering the cell, the company said.

The test provides information about an individual’s immune status with a positive predictive value of 95.5% even when disease incidence in a population is as low as 3%, said Julie Sawyer Montgomery, the president of Beckman Coulter.

The Brea, Calif., company also said it is awaiting U.S. Food and Drug Administration emergency-use authorization for its interleukin-6 test, which could provide valuable information in clinical decision-making for Covid-19 patients.

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