The latest addition to the Biomedical Advanced Research and Development Authority’s (BARDA) COVID-19 countermeasure portfolio is an automated total antibody test being developed in partnership with Siemens Healthineers.
The serological, lab-based test proposes to detect two items in human serum and plasma: SARS-CoV-2 IgM and longer-lasting IgG antibodies. It could allow medical professionals to identify whether patients display an immune response to SARS-CoV-2 — the virus behind COVID-19. Doing so would indicate either a recent or prior infection.
This month, Siemens intends to begin ramping up production of the test at facilities in Walpole, Mass., and Newark, Del. Its end goal is to reach capacity exceeding 50 million antibody tests per month.
Currently, Siemens has more than 2,000 fully automated immunoassay analyzers — Atellica IM SARS-CoV-2 Total and ADVIA Centaur SARS-SoV-2 Total — in hospitals and certain laboratories throughout the United States. The Atellica IM test can run up to 440 tests per hour and provide results in 10 minutes, while ADVIA can test up to 240 samples per hour and provide results within 18 minutes. Both are operating under an Emergency Use Authorization from the U.S. Food and Drug Administration.