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FDA Grants EUAs for Coronavirus Tests from 3B Blackbio, Ohio State, and Others

NEW YORK — The US Food and Drug Administration this week granted separate Emergency Use Authorizations (EUAs) for SARS-CoV-2 tests developed by 3B Blackbio Biotech India, Bioperfectus Technologies, Omnipathology Solutions Medical, Biohit Healthcare, and Ohio State University.

3B Blackbio's TRUPCR SARS-CoV-2 Kit is designed to detect the virus' N and RdRP genes in nasopharyngeal or oropharyngeal swabs, anterior nasal and mid-turbinate nasal swabs, nasopharyngeal aspirate/wash or nasal aspirates, and bronchoalveolar lavage specimens. It runs on Thermo Fisher Scientific's Applied Biosystems QuantStudio system or Qiagen's Rotor-Gene Q 5Plex HRM instrument.

Bioperfectus Technologies' COVID-19 Coronavirus Real Time PCR Kit is designed to detect the SARS-CoV-2 ORF1ab and N genes in nasopharyngeal, oropharyngeal, anterior nasal, and mid-turbinate nasal swabs, as well as nasal aspirates, nasal washes, bronchoalveolar lavage, and sputum. It runs on the Applied Biosystems 7500 or the Roche LightCycler 480 PCR systems.

Omnipathology's Omni COVID-19 ASSAY by RT-PCR is designed to detect regions of the SARS-CoV-2 N gene — using the same primer and probe sets used with the US Centers for Disease Control and Preventions' 2019-Novel Coronavirus Real-Time RT-PCR Diagnostic Panel, which has also received an EUA from the FDA — in nasopharyngeal, oropharyngeal, anterior nasal, and mid-turbinate nasal swab, and nasopharyngeal wash/aspirate, nasal aspirate, and bronchoalveolar lavage. It runs on Becton Dickinson's BD Max nucleic acid extraction and RT-PCR system.

The Biohit SARS-CoV-2 IgM/IgG Antibody Test Kit is an immunochromatographic assay designed to detect the immunoglobulin M (IgM) and immunoglobulin G (IgG) antibodies against the virus in human serum, plasma, and venipuncture whole blood.

All four tests may be performed by any CLIA-certified lab.

Ohio State's OSUWMC COVID-19 RT-PCR test is designed to detect regions in the SARS-CoV-2 N gene in nasal, oropharyngeal, and nasopharyngeal swab specimens. It runs on the Applied Biosystems 7500 Fast RT-PCR instrument and may only be performed at Ohio State University's Wexner Medical Center.