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Table 2: Rapid Influenza Diagnostic Tests (RIDTs)

Table 2: 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 Specimens1 CLIA Waived2
Alere Binax Now Influenza A & B Card 2 Alere Reader NPS, NS direct Yes
Becton Dickinson & Co. BD Veritor™ Flu A + B BD Veritor Reader 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
Remel/Thermo Fisher XPECT™ Flu A & B N/A Nasal wash No
  1. Available FDA cleared tests as of February 7, 2018. List may not include all available test kits approved by the FDA.
  2. Approved respiratory specimens according to manufacturer’s package insert.
  3. Ref: http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/index.html
  4. FDA = U.S. Food and Drug Administration
  5. N = nasal
  6. NP = nasopharyngeal
  7. A = aspirate
  8. S = swab
  9. W = wash
  10. N/A = RIDT does not use analyzer device
  11. VTM = viral transport media

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.

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