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BioFire Diagnostics, UMass Medical Coronavirus Tests Get FDA Emergency Use Authorization

NEW YORK — The US Food and Drug Administration last week granted separate Emergency Use Authorizations for PCR-based SARS-CoV-2 tests developed by BioFire Diagnostics and the University of Massachusetts Medical School.

The BioFire Respiratory Panel 2.1-EZ is a point-of-care test designed to detect and differentiate between nucleic acids from SARS-CoV-2 and 20 other viral and bacterial respiratory pathogens — including various influenza A subtypes, respiratory syncytial virus, and Bordetella pertussis — in nasopharyngeal swabs.

According to BioFire, a subsidiary of Marcy-l'Étoile, France-based BioMérieux, the test is a simplified version of its previously authorized BioFire Respiratory Panel 2.1. The new test uses the same components as the earlier one but includes a sample buffer ampule that is easier to handle and dispense, while the testing instructions have been updated for patient care settings.

The test runs on the BioFire FilmArray 2.0 instrument and may be used by any lab CLIA-certified to perform high-, moderate-, or waived complexity tests.

The UMass Molecular Virology Laboratory 2019-nCoV rRT-PCR Dx Panel is designed to detect the N gene of the virus in nasal, midturbinate nasal, nasopharyngeal, and oropharyngeal swabs, as well as in nasopharyngeal aspirate and bronchoalveolar lavage specimens.

Nucleic acid extraction is performed on either Qiagen's QIAcube or Thermo Fisher Scientific's KingFisher Flex Magnetic Particle Processor, and the test runs on Bio-Rad Laboratories' CFX96 Touch Real-Time PCR Detection System.

The test may be performed only at the UMass Molecular Virology Laboratory in Worcester, Massachusetts, according to the FDA.