NEW YORK — The US Food and Drug Administration has issued separate Emergency Use Authorizations for PCR-based SARS-CoV-2 tests developed by Hologic, Genetworx and PacificDx.
Hologic's Aptima SARS-CoV-2/Flu assay is an automated multiplexed target nucleic acid amplification test intended for the simultaneous detection and differentiation of RNA from SARS-CoV-2, influenza A, and/or influenza B in nasopharyngeal, nasal, and mid-turbinate swab specimens.