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Beckman Coulter Receives CE Mark for SARS-CoV-2 IgG Antibody Test

NEW YORK – Beckman Coulter announced Monday that its Access SARS-CoV-2 IgG antibody test is now available in countries accepting the CE mark after receiving CE marking last week.

The serology test detects IgG antibodies that target the receptor-binding domain of the spike protein and has 100 percent sensitivity and nearly 100 percent specificity, the firm said in a statement. A spokesperson for Beckman Coulter, a Danaher business, said the company has submitted the test to the US Food and Drug Administration for Emergency Use Authorization and is expecting the decision soon.

Brea, California-based Beckman Coulter has shipped tests to more than 400 facilities in the US and ramped up its manufacturing to produce and deliver 30 million tests per month. The test runs on many of Beckman Coulter's analyzers, which can deliver up to 400 tests an hour. It also runs on the Access 2 analyzer, a table-top instrument for smaller hospitals and clinics, the company said.

Henry Ford Health System in Detroit independently validated the test, finding sensitivity of 100 percent when running the test on 204 PCR-confirmed patient samples two weeks after the PCR test. It also found a specificity of 100 percent after testing 80 patient samples from before the COVID-19 pandemic, the hospital said.

Beckman Coulter added it will be seeking CE marking for its Access SARS-CoV-2 IgM test in the near future as well.