NEW YORK — The US Food and Drug Administration last week granted Emergency Use Authorization for Thermo Fisher Scientific's OmniPath COVID-19 Total Antibody ELISA Test for SARS-CoV-2.
The test was developed by Thermo Fisher in a collaboration with WuXi Diagnostics and the Mayo Clinic that was announced in May. It 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 Thermo Fisher's fully automated Dynex Agility ELISA system.
The test may be run in the automated way by any lab CLIA-certified to perform moderate-complexity tests, the FDA said in its authorization. It may be performed in either manual or automated formats by labs certified to perform high-complexity tests.
Waltham, Massachusetts-based Thermo Fisher has also received EUA from the FDA for its RT-PCR-based Applied Biosystems TaqPath COVID-19 Combo Kit for SARS-CoV-2.