TABLE 1

FDA-cleared influenza A/B rapid antigen tests

ManufacturerProductPlatform/instrumentApproved specimen type(s)a
AbbottBinax Now Influenza A & B Card 2Alere readerNPS, NS direct
Becton Dickinson & Co.BD Veritor Flu A + BBD Veritor reader, BD Veritor Plus analyzerNPS, NS direct, NPW, NA, NPS in VTM
Quidel Corp.Sofia Influenza A + B FIASofia FIA analyzer, Sofia 2 FIA analyzerNS, NPS, NPA, NPW direct, NPW in VTM
Quidel Corp.QuickVue Influenza A + BNANPS, NS direct
Princeton BioMeditech Corp.BioSign Flu A & B, Labsco Advantage Flu A & B, LifeSign Status Flu A & B, OraSure QuickFlu Rapid A + B, Polymedco Poly stat Flu A&B, Sekisui Diagnostics OSOM Ultra Flu A & B, Meridian BioScience ImmunoCard Stat! Flu A&B, McKesson Consult Diagnostics Influenza A&BNANS, NPS direct, NPA, NPW
Remel/Thermo FisherXpect Flu A & BNANasal wash
  • a NPS, nasopharyngeal swab; NS, nasal swab; NA, nasal aspirate; NPA, nasopharyngeal aspirate; NPW, nasopharyngeal wash; VTM, viral transport medium; NA, not applicable. Specimen types listed in bold are CLIA waived.