Thermo Fisher’s OmniPath COVID-19 Total Antibody ELISA Test for SARS-CoV-2 Granted FDA Emergency Use Authorization

By LabMedica International staff writers
Posted on 08 Oct 2020

Thermo Fisher Scientific Inc.’s (Waltham, MA, USA) OmniPath COVID-19 Total Antibody ELISA Test for SARS-CoV-2 has been granted Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA).

Thermo Fisher has developed the test in collaboration with WuXi Diagnostics and the Mayo Clinic. The OmniPath COVID-19 Total Antibody ELISA Test is designed to detect immunoglobulin M, A, and G against SARS-CoV-2 in human serum. The assay uses a 96-well microplate and can be run either manually or with the fully automatic Dynex Agility ELISA system from Thermo Fisher.

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According to the FDA, the OmniPath COVID-19 Total Antibody ELISA Test can be run in the automated way by any lab that is CLIA-certified to perform moderate-complexity tests. The test can be performed in either manual or automated formats by labs certified to perform high-complexity tests.