TABLE 1.
FDA-cleared influenza A/B rapid antigen tests
| Manufacturer | Product | Platform/instrument | Approved specimen type(s)a |
|---|---|---|---|
| Abbott | Binax Now Influenza A & B Card 2 | Alere reader | NPS, NS direct |
| Becton Dickinson & Co. | BD Veritor Flu A + B | BD Veritor reader, BD Veritor Plus analyzer | NPS, NS direct, NPW, NA, NPS in VTM |
| Quidel Corp. | Sofia Influenza A + B FIA | Sofia FIA analyzer, Sofia 2 FIA analyzer | NS, NPS, NPA, NPW direct, NPW in VTM |
| Quidel Corp. | QuickVue Influenza A + B | NA | NPS, 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&B | NA | NS, NPS direct, NPA, NPW |
| Remel/Thermo Fisher | Xpect Flu A & B | NA | Nasal 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.