TABLE 2.
FDA-cleared and CLIA-waived respiratory virus NAATs
| Manufacturer | Product | Platform/instrument | Approved specimen type(s)a |
|---|---|---|---|
| Abbott | Alere i Influenza A&B 2 | Alere i (ID NOW) | NS direct, NPS direct, NS, NPS |
| Abbott | Alere i Influenza RSV | Alere i (ID NOW) | NPS direct, NPS |
| BioFire Diagnostics | BioFire FilmArray respiratory panel EZ | BioFire FilmArray | NPS |
| Cepheid | Xpert Xpress Flu | GeneXpert Xpress | NS, NPS |
| Cepheid | Xpert Xpress Flu/RSV | GeneXpert Xpress | NS, NPS |
| Mesa Biotech, Inc. | Accula Flu A/Flu B | Accula Dock | NS |
| Mesa Biotech, Inc. | Accula RSV | Accula Dock | NS |
| Roche | cobas Liat Influenza A/B assay | cobas Liat | NPS |
| Roche | cobas Liat Influenza A/B & RSV assay | cobas Liat | NPS |
| Sekisui Diagnostics | Silaris Influenza A&B test | Silaris Dock | NS direct |
a
NPS, nasopharyngeal swab; NS, nasal swab.