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BioMérieux, Beijing Wantai Coronavirus Antibody Tests Get FDA Emergency Use Authorization

NEW YORK — The US Food and Drug Administration last week granted separate Emergency Use Authorizations (EUAs) for two SARS-CoV-2 serology tests developed by BioMérieux and one being offered by Beijing Wantai Biological Pharmacy.

BioMérieux's Vidas SARS-CoV-2 IgM test is designed to detect IgM antibodies against the virus, while the company's Vidas SARS-CoV-2 IgG test detects IgG antibodies. Both tests combine a two-step sandwich enzyme immunoassay method with final fluorescence detection and use human serum and plasma specimens.

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

In April, Marcy l'Étoile, France-based BioMérieux reported a nearly 22 percent jump in first quarter revenues on strong demand for its SARS-CoV-2-related molecular biology products. 

The Wantai SARS-CoV-2 Ab ELISA test is designed to detect total antibodies, including immunoglobulin G (IgG) and M (IgM), against the virus in human serum and plasma. It is a two-step incubation/antigen sandwich enzyme immunoassay and may be used by any lab CLIA-certified to perform high-complexity tests, according to the FDA.

Last month, Beijing Wantai received EUA from the FDA for a rapid, lateral flow SARS-CoV-2 assay.