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Bio-Rad, United Biomedical Get FDA Emergency Use Authorizations for Coronavirus Tests

NEW YORK — The US Food and Drug Administration last week granted separate Emergency Use Authorizations for SARS-CoV-2 tests developed by Bio-Rad Laboratories and United Biomedical.

The Bio-Rad Reliance SARS-CoV-2 RT-PCR Assay Kit is designed to detect the SARS-CoV-2 N gene in upper respiratory tract specimens including nasopharyngeal, oropharyngeal, nasal, anterior nasal, and midturbinate nasal swabs, as well as nasal aspirates and nasal washes.

RNA purification may be performed using Thermo Fisher Scientific's MagMAX Viral/Pathogen Nucleic Acid Isolation Kit and Qiagen's QIAamp Viral Mini Kit. The test runs on Bio-Rad's CFX Opus 96, CFX96 Touch, CFX96 Dx, CFX Opus 384, and CFX384 Touch RT-PCR systems, and Thermo Fisher Scientific's Applied Biosystems 7500 Fast RT-PCR instrument, according to Hercules, California-based Bio-Rad.

United Biomedical's UBI SARS-CoV-2 ELISA is designed to detect immunoglobulin G against SARS-CoV-2 in serum and plasma using synthetic peptides derived from the M, S, and N proteins of the virus. The test uses a microplate reader such as Molecular Devices' VersaMax, the Hauppauge, New York-based company said.

Both assays may be used by labs CLIA-certified to perform high-complexity tests, according to the FDA.