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Thermo Fisher Scientific Unit Phadia Gets FDA EUA for Coronavirus Antibody Test

NEW YORK — The US Food and Drug Administration on Monday granted Emergency Use Authorization for a SARS-CoV-2 antibody test developed by Swedish Thermo Fisher Scientific subsidiary Phadia.

The EliA SARS-CoV-2-Sp1 IgG Test is a fluoro-enzyme immunoassay designed for the qualitative and semi-quantitative detection of immunoglobulin G against SARS-CoV-2 in serum and plasma. It runs on the Phadia 250 analyzer with first results available in two hours, according to the company.

The test may be used by any lab CLIA-certified to perform moderate- or high-complexity tests, the FDA said.