FDA Gives Emergency Authorization for Use of Siemens Total Antibody Test


Siemens Healthineers Receives FDA Emergency Use Authorization for its SARS-CoV-2 Total Antibody Test that Delivers Superior Clinical Performance


Tarrytown, NY |  Jun 01, 2020

• Total antibody test has demonstrated 100 percent sensitivity and 99.8 percent specificity in identifying SARS-CoV-2 antibodies.
• The test detects the antibodies believed to neutralize the SARS-CoV-2 virus; specifically targeting antibodies that attach to a spike protein on the surface of the virus.
• The test is available on the company’s high-throughput analyzers that can deliver up to 440 tests/hour1 and report results in as few as 10 minutes.
• The company has production capacity for more than 50 million tests per month as the pandemic evolves to address the largest installed base in the U.S.

Siemens Healthineers announced today the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for its laboratory-based total antibody test to detect the presence of SARS-CoV-2 antibodies including IgM and IgG in blood. Test data demonstrated 100 percent sensitivity2 and 99.8 percent specificity. The total antibody test allows for identification of patients who have developed an adaptive immune response, which indicates recent infection or prior exposure. Testing can begin immediately with more than one million tests already shipped to health systems and laboratories.

A spike protein on the surface of the SARS-CoV-2 virus enables the virus to penetrate and infect human cells found in multiple organs and blood vessels….Read More:



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