Firstly, could you share the milestones or developments in COVID-19 serology testing capabilities that you and your colleagues at Siemens Healthineers have achieved over the past year?
Siemens Healthineers launched its laboratory-based total antibody test in May 2020, to detect the presence of SARS-CoV-2 total antibodies (including IgM and IgG antibodies) in the blood. Importantly, the test detects antibodies to the SARS-CoV-2 Spike Protein S1 Receptor-Binding Domain (S1RBD), a key protein on the surface of the virus. The selection of the S1RBD is aligned with multiple vaccines that are either available or in development, with the goal of producing protective antibodies. The test has US FDA EUA authorization. In a study published in July 2020, Public Health England evaluated COVID-19 serology tests from major manufacturers, and concluded that the Siemens test was the only one that met both the sensitivity and specificity requirements set out by the UK Medicines and Healthcare products Regulatory Agency (MHRA).1
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