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Thermo Fisher Gets CE Mark for Coronavirus Antibody Tests

NEW YORK — Thermo Fisher Scientific said on Monday that it has received CE marking for its EliA SARS-CoV-2-Sp1 IgG test and its OmniPath COVID-19 Total Antibody ELISA Test for SARS-CoV-2.

The EliA SARS-CoV-2-Sp1 IgG test is designed for the quantitative detection of immunoglobulin G against the virus. It runs on Thermo Fisher's Phadia 250 instrument, which the company said can process up to 60 results per hour.

In addition to being available in European nations that accept the CE mark, the test is commercially available in the US while the US Food and Drug Administration reviews Thermo Fisher's Emergency Use Authorization submission, the Waltham, Massachusetts-based company said.

The OmniPath COVID-19 Total Antibody ELISA Test is designed to detect immunoglobulin M, A, and G against SARS-CoV-2 and can be run either manually or with Thermo Fisher's fully automated Dynex Agility ELISA system. It received EUA from the FDA earlier this month.