October 12, 2020 – Thermo Fisher Scientific Inc. (Waltham, MA) introduced two new SARS-CoV-2 antibody tests:
- The Thermo Scientific OmniPATH COVID-19 Total Antibody ELISA test
- The Thermo Scientific EliA SARS-CoV-2-Sp1 IgG test
These new tests for detecting COVID-19 antibodies expand the company’s response to the pandemic, which ranges from molecular diagnostic tests and sample collection products, to personal protective equipment, to support of therapy and vaccine development and manufacturing.
The OmniPATH COVID-19 Total Antibody ELISA test, developed in conjunction with the Mayo Clinic and WuXi Diagnostics was granted Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for qualitative detection of total antibodies to SARS-CoV-2, including immunoglobulin M (IgM), immunoglobulin A (IgA) and immunoglobulin G (IgG).
The EliA SARS-CoV-2-Sp1 IgG test is commercially available in accordance with the FDA’s “Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised)”.
The EUA is currently under review by the FDA. The EliA test is designed for automated processing of up to 60 results per hour on the Thermo Scientific Phadia 250 instrument. The EliA test is quantitative within markets that accept the CE mark and semi-quantitative in the U.S. Individual IgM and IgA EliA tests are also available now for research use only.
The tests are now available in Europe and countries accepting the CE Mark.