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Beckman Coulter Receives Emergency Use Authorization for SARS-CoV-2 Antibody Test

NEW YORK – Beckman Coulter announced Monday its Access SARS-CoV-2 IgG assay received Emergency Use Authorization from the US Food and Drug Administration.

The serology test targets IgG antibodies that recognize the receptor binding domain of the spike protein that SARS-CoV-2 uses to bind to a human cell receptor. These antibodies have the potential to be neutralizing, the company said. The test has confirmed 100 percent sensitivity and nearly 100 percent specificity, the firm added. 

The assay can run on Beckman Coulter's Access 2 analyzer, a table-top analyzer for smaller hospitals and clinics, as well as its other immunoassay analyzers, including the DxI 800, the DxI 600, and the DxCi. The firm said many of its analyzers can run up to 400 tests per hour.

Brea, California-based Beckman Coulter said it has started distributing the test to countries around the world accepting the EUA and CE mark and has shipped tests to more than 400 facilities in the US. The firm is able to ship more than 30 million tests per month, it said. The test received CE marking earlier this month. 

The test was independently validated by Henry Ford Health System in Detroit, which found sensitivity and specificity at 100 percent at two weeks after PCR testing. "A lot has been written about accuracy issues with the initially launched antibody tests, but a test at this level offers positive predictive values greater than 90 percent even in very low prevalence communities," Beckman Coulter President Julie Sawyer Montgomery said in a statement. "And in areas hardest hit by the virus, the positive predictive values of our assay are greater than 98 percent."