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: http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/index.html
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 Centers for Disease Control and Prevention or the Department of Health and Human Services.