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BIOFIRE® SPOTFIRE® Respiratory /Sore Throat Panels

Comprehensive Onsite PCR Results in ~15 Minutes.

The BIOFIRE Respiratory/Sore Throat (R/ST) Panels enable testing for both respiratory or sore throat pathogens on the same panel, 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. 

BIOFIRE SPOTFIRE Respiratory Panels

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, 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 convenience.
  • 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

Panels Menu

The SPOTFIRE R/ST Panel is a rapid multiplex PCR test offering two uses based on patient signs and symptoms: either a respiratory test with a nasopharyngeal swab or a sore throat test with a throat swab.

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

1 PCR Test. 15 Targets. ~15 Minutes.

Based on patient symptoms and the type of sample collected, users can select either the Respiratory or Sore Throat menu.

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)

  

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

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

Based on patient symptoms and the type of sample collected, users can select either the Respiratory or Sore Throat menu.

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 (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)

FDA Cleared | CLIA Waived

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

1 PCR Test. 5 Targets. ~15 Minutes.

Based on patient symptoms and the type of sample collected, users can select either the Respiratory or Sore Throat menu.

RESPIRATORY

Viruses

  • Coronavirus SARS-CoV-2 
  • Human rhinovirus 
  • Influenza A virus 
  • Influenza B virus 
  • Human rhinovirus/enterovirus
  • Respiratory syncytial virus Influenza A virus A/H1-2009

SORE THROAT 

Viruses

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

Bacteria

  • Streptococcus pyogenes (group A Strep)

FDA Cleared

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
CE 2797		BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel
FDA Cleared | CLIA Waived
Part Number:423485
Quantity:30 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) 
Overall Respiratory Performance
(NPS specimens):		98.5% PPA, 99.1% NPA1
Overall Sore Throat Performance
(TS specimens):		95.7% PPA, 99.0% NPA195.9% PPA, 99.0% NPA1

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

 

 InformationBIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel
CE 2797		BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel
FDA 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

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

 

 InformationBIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel
Part Number:423485
Quantity:30 Tests
Sample Type: Nasopharyngeal swab (NPS) or throat swab (TS) in 1 to 3 mL of transport media
Storage Conditions: All kit components stored at room temperature (15-25 °C) 
Overall Respiratory Performance
(NPS specimens):		98.5% PPA, 99.1% NPA*
Overall Sore Throat Performance
(TS specimens):		96.6% PPA, 99.1% NPA*
 InformationBIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel Mini
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

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

 

 InformationBIOFIRE® SPOTFIRE® Respiratory (R) PanelBIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini
Part Number:
424461424589
Quantity:30 Tests30 Tests
Sample Type: Nasopharyngeal swab in 1 to 3 mL of viral transport media Nasopharyngeal swab in 1 to 3 mL of viral 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 Performance:98.5% PPA, 99.1% NPA*98.7% PPA, 98.4% NPA*

FDA Cleared | CLIA Waived

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

Resources

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

Download PDF
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

Download PDF

BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel Mini Information Sheet

Download PDF

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