Purpose
This table provides a list of available tests by manufacturer that offer results in 10-15 minutes and differentiate between influenza A and B.
Table: Available FDA-Cleared Rapid Influenza Diagnostic Tests (Antigen Detection Only)
| These tests provide results in 10-15 minutes and differentiate between influenza A and B | ||||
|---|---|---|---|---|
| Manufacturer | Product | Platform/Instrument | Approved Specimens2 | CLIA Waived3 |
| Abbott | Binax Now Influenza A & B Card 2 | DIGIVALTM | NPS, NS direct | Yes |
| Becton Dickinson & Co. | BD Veritor™ Flu A + B | BD Veritor Reader | NPS, NS direct | Yes |
| Becton Dickinson & Co. | BD Veritor™ Flu A + B | BD Veritor Plus Analyzer | NPS, NS direct | Yes |
| Quidel Corp. | Sofia® Influenza A + B FIA | Sofia FIA Analyzer | NS, NPS, NPA, NPW direct, NP, NPA, NPW in VTM | Yes |
| Quidel Corp. | Sofia® Influenza A + B FIA | Sofia 2 FIA Analyzer | NS, NPS, NPA, NPW direct, NP, NPA, NPW in VTM | Yes |
| Quidel Corp. | QuickVue® Influenza A + B | N/A | NPS, NS direct | Yes |
| Princeton BioMeditech Corp. | BioSign® Flu A & B LABSCO Advantage Flu A & B LifeSign LLC 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 | N/A | NS, NPS direct (waived) NPA, NPW (not waived) | Yes |
| Becton Dickinson & Co. | BD Veritor™ Flu A + B | BD Veritor Reader | NPW, NA, NPS in VTM | No |
| Becton Dickinson & Co. | BD Veritor™ Flu A + B | BD Veritor Plus Analyzer | NPW, NA, NPS in VTM | No |
| Remel/Thermo Fisher | XPECT™ Flu A & B | N/A | Nasal wash | No |
| Sekisui Diagnostics, LLC | Acucy Influenza A&B Test | The Acucy System | NPS, NS direct | Yes |
| Sekisui Diagnostics, LLC | OSOM Ultra Plus Flu A&B Test | N/A | NPS, NPA, NPW, NS | Yes |
| Access Bio, Inc. | CareStart Flu A&B Plus | N/A | NPS | No |
- Available FDA cleared tests as of August 2020. List may not include all available test kits approved by the FDA.
- Approved respiratory specimens according to manufacturer’s package insert.
- Ref:
A = aspirate
FDA = U.S. Food and Drug Administration
N = nasal
N/A = RIDT does not use analyzer device
NP = nasopharyngeal
S = swab
VTM = viral transport media
W = wash
Disclaimer: Use of trade names or commercial sources is for identification only and does not imply endorsement by the Situs Slot Gacor or the Department of Health and Human Services.