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BIOFIRE® SPOTFIRE® Respiratory/Sore Throat Panels

Comprehensive Onsite PCR Results in ~15 Minutes.

The BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panels enable testing for respiratory pathogens from either a nasopharyngeal swab or a throat swab, providing a flexible respiratory solution to meet the unique needs of point-of-care settings.

  

Disclaimer: Product availability varies by country. Please consult your local bioMérieux representative for product availability in your country. 

Overview

BIOFIRE® SPOTFIRE® Respiratory/Sore Throat Panels bring PCR diagnostic power closer to patients via a point-of-care syndromic approach that combines symptom-driven testing for a broad grouping of probable respiratory pathogens into one rapid test. With its revolutionary portfolio of versatile, respiratory PCR tests, clinicians can provide patient results in about 15 minutes during their appointments.

With these panels, healthcare professionals have the potential to:

 

  • Inform Clinical Decisions: High sensitivity, specificity, and reliability provides results clinicians can trust. Testing for more than flu, RSV, and SARS-CoV-2 with one test provides healthcare professionals with a fuller picture.
  • Support Antimicrobial Stewardship: Comprehensive results in a clinically actionable timeframe may inform comprehensive diagnosis and optimize care and antimicrobial stewardship. Targeted, informed therapy can reduce the unnecessary prescription of antimicrobials.
  • Improve Patient Satisfaction: Using the right test, the first time, to detect multiple pathogens may result in reduced follow-up appointments, swabbing, and testing, which could improve patient comfort, experience, and convenience1.
  • Optimize Operations: The simple workflow and quick turnaround time enables rapid and comprehensive answers, which can be communicated to patients during the appointment, potentially reducing the need for callbacks or expensive and slow send-out testing.

BIOFIRE SPOTFIRE R Panel Steps

References

1. Meltzer A, et al. J Am Coll Emerg Physicians Open. 2024 Oct 23;5(5):e13306.

Panels Menu

The BIOFIRE SPOTFIRE R/ST Panels offer rapid multiplex PCR tests detecting up to 15 respiratory pathogens to provide accurate and comprehensive diagnostic results during a patient visit. Designed with flexibility in mind, the panels allow users to choose between the Respiratory or Sore Throat testing menu based on patient symptoms and the type of sample collected.

BIOFIRE® SPOTFIRE® RESPIRATORY/SORE THROAT (R/ST) PANEL

1 PCR Test. Up to 15 Targets. ~15 Minutes.

CE Marked

FDA Cleared | CLIA Waived

  

RESPIRATORY

Viruses

  • Adenovirus
  • Coronavirus SARS-CoV-2
  • Coronavirus (seasonal)
  • Human metapneumovirus
  • Human rhinovirus/enterovirus
  • Influenza A virus
    • Influenza A virus A/H1-2009
    • Influenza A virus A/H3
  • Influenza B virus
  • Parainfluenza virus
  • Respiratory syncytial virus

Bacteria

  • Bordetella parapertussis
  • Bordetella pertussis
  • Chlamydia pneumoniae
  • Mycoplasma pneumoniae

SORE THROAT 

Viruses

  • Adenovirus
  • Coronavirus SARS-CoV-2*
  • Coronavirus (seasonal)
  • Human metapneumovirus
  • Human rhinovirus/enterovirus
  • Influenza A virus
    • Influenza A virus A/H1-2009
    • Influenza A virus A/H3
  • Influenza B virus
  • Parainfluenza virus
  • Respiratory syncytial virus

Bacteria

  • Chlamydia pneumoniae
  • Mycoplasma pneumoniae
  • Streptococcus dysgalactiae (group C/G Strep)
  • Streptococcus pyogenes (group A Strep)

*Coronavirus SARS-CoV-2 is not cleared for use on the Sore Throat Menu in the United States.

Product availability varies by country, please consult your bioMérieux representative.


BIOFIRE® SPOTFIRE® RESPIRATORY/SORE THROAT (R/ST) PANEL MINI

1 PCR Test. 5 Targets. ~15 Minutes.

FDA Cleared | CLIA Waived

  

RESPIRATORY

Viruses

  • Coronavirus SARS-CoV-2 
  • Human rhinovirus 
  • Influenza A virus 
  • Influenza B virus 
  • Respiratory syncytial virus

SORE THROAT 

Viruses

  • Human rhinovirus 
  • Influenza A virus 
  • Influenza B virus 
  • Respiratory syncytial virus

Bacteria

  • Streptococcus pyogenes (group A Strep)

Services & Support

Make the Most of Your BIOFIRE® SPOTFIRE® Investment

Our goal is to provide you with the best support available while minimizing any disruption to your workflow.

  • Best-in-class application and engineering services
  • A skilled team dedicated to your success providing global product support, solution training courses, connectivity assistance, and instrument or chemistry related troubleshooting

Specs & Resources

Technical Specifications

 InformationBIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel
BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel
Certification:CE 2797FDA Cleared | CLIA Waived
Part Number:423485423485
Quantity:30 Tests30 Tests
Sample Type: Nasopharyngeal swab (NPS) or throat swab (TS) in 1 to 3 mL of transport mediaNasopharyngeal swab (NPS) in 3 mL of transport media or throat swab (TS) in 1 mL of transport media
Storage Conditions: All kit components stored at room temperature (15-25 °C) All kit components stored at room temperature (15-25 °C) 
Overall Respiratory Performance
(NPS specimens):
98.5% PPA, 99.1% NPA198.5% PPA, 99.1% NPA1
Overall Sore Throat Performance
(TS specimens):
95.7% PPA, 99.0% NPA195.9% PPA, 99.0% NPA1

 

 InformationBIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel Mini
Certification:FDA Cleared | CLIA Waived
Part Number:424537
Quantity:30 Tests
Sample Type: Nasopharyngeal swab (NPS) in 3 mL of transport media or throat swab (TS) in 1 mL of transport media
Storage Conditions: All kit components stored at room temperature (15-25 °C)
Overall Respiratory Performance
(NPS specimens):
98.7% PPA, 98.4% NPA2
Overall Sore Throat Performance
(TS specimens):
96.2% PPA, 97.9% NPA2

1. Overall performance based on prospective clinical study for the BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel, data on file, BioFire Diagnostics
2. Overall performance based on prospective clinical study for the BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel Mini, data on file, BioFire Diagnostics

 


Resources

BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel Information Sheet | CE 2797

BIOFIRE SPOTFIRE Respiratory Sore Throat RST Panel Information Sheet - FDA Cleared - CLIA Waived.jpg

BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel Information Sheet - FDA Cleared | CLIA Waived

BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel Mini Information Sheet - FDA Cleared | CLIA Waived