TABLE 3

Selected FDA-cleared but nonwaived respiratory virus NAATs

ManufacturerProductPlatform/instrumentApproved specimen type(s)a
BioFire DiagnosticsBioFire FilmArray respiratory panel 2BioFire FilmArrayNPS
BioFire DiagnosticsBioFire FilmArray respiratory panelBioFire FilmArrayNPS
BioFire DiagnosticsBioFire FilmArray pneumonia panelBioFire FilmArrayIS, TRA, BAL fluid
CepheidXpert Flu/RSV XCGeneXpertNPS, NPA, NPW
CepheidXpert Xpress FluGeneXpertNS, NPS
CepheidXpert Xpress Flu/RSVGeneXpertNS, NPS
DiasorinSimplexa Flu A/B & RSV DirectLiason MDXNPS
GenMark DiagnosticsePlex respiratory pathogen panelePlexNPS
Hologic, Inc.Panther Fusion Flu A/B/RSV assayPanther FusionNPS
Hologic, Inc.Panther Fusion AdV/HMPV/RV assayPanther FusionNPS
Hologic, Inc.Panther Fusion Paraflu assayPanther FusionNPS
LuminexAries Flu A/B & RSV assayAriesNPS
LuminexVerigene Respiratory Pathogens FlexVerigene reader and processor SPNPS
QiagenQIAstat-Dx respiratory panelQIAstat-DxNPS
QuidelSolana Influenza A + B assaySolanaNS, NPS
QuidelSolana Influenza RSV+hMPV assaySolanaNS, NPS
  • a NPS, nasopharyngeal swab; NS, nasal swab; NPA, nasopharyngeal aspirate; NPW, nasopharyngeal wash; IS, induced/expectorated sputum; TRA, tracheal aspirate; BAL, bronchoalveolar lavage.