BIOFIRE® BCID2 Panel

BIOFIRE Blood Culture Identification 2 Panel (BCID2)

The BIOFIRE® Blood Culture Identification 2 (BCID2) Panel enables rapid and accurate automated detection of pathogens and antibiotic resistance genes associated with bloodstream infections.

  • Simple: 2 minutes of hands-on time
  • Fast: Turnaround time of about 1 hour
  • Comprehensive: Simultaneously tests for 43 targets and identifies pathogens in more than 9 out of 10 positive blood cultures. BCID2 detects 10 antimicrobial resistance genes and emerging pathogens like C.auris and S.maltophilia
  • Accurate: The average positive agreement rate (or sensitivity) across all pathogens on the BCID2 panel is 99%, and the negative agreement rate (or specificity) is 99.8%1

1The stated performance is the aggregate of the prospective data from the clinical study.

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Simple, comprehensive pathogen ID from blood cultures

The BIOFIRE®  Blood Culture Identification 2 (BCID2) Panel tests for a comprehensive list of 33 pathogens and 10 antibiotic resistance genes associated with bloodstream infections. With just one test you can identify pathogens more than 9 out of 10 positive blood cultures in about 1 hour with only 2 minutes of hands-on time. The BIOFIRE®  BCID2 Panel is designed for the BIOFIRE® systems, an FDA, CE-IVD, and TGA certified multiplex PCR system that integrates sample preparation, amplification, detection and analysis.

  • Simple: 2 minutes of hands-on time
  • Fast: Turnaround time of about 1 hour
  • Comprehensive: Simultaneously tests for
    43 targets and identifies pathogens in more than
    9 out of 10 positive blood cultures. BCID2 detects 10 antimicrobial resistance genes and emerging pathogens like C.auris and S.maltophilia
  • Accurate: The average positive agreement rate (or sensitivity) across all pathogens on the BCID2 panel is 99%, and the negative agreement rate (or specificity) is 99.8%2.

BIOFIRE® BCID2 is one of five FDA-cleared and CE-marked panels for use on the BIOFIRE® systems. Taken together, the BIOFIRE® FILMARRAY® panels comprise the largest infectious disease pathogen menu commercially available. The other available panels are:

2The stated performance is the aggregate of the prospective data from the clinical study.

43 targets at once

BIOFIRE® BCID2 Panel targets:

Gram+  Bacteria Gram–  Bacteria
Enterococcus faecalis
Enterococcus faecium
Listeria monocytogenes
Staphylococcus
  Staphylococcus aureus
  Staphylococcus epidermidis
  Staphylococcus lugdunensis
Streptococcus
  Streptococcus agalactiae
  Streptococcus pyogenes
  Streptococcus pneumoniae

 
Acinetobacter calcoaceticus- baumannii complex
Bacteroides fragilis
Enterobacterales
  Enterobacter cloacae complex
  Escherichia coli
  Klebsiella aerogenes
  Klebsiella oxytoca
  Klebsiella pneumoniae group
  Proteus
  Salmonella
  Serratia marcescens
Haemophilus influenzae
Neisseria meningitidis
Pseudomonas aeruginosa
Stenotrophomonas maltophilia
 
Yeast Antibiotic Resistance
Candida albicans
Candida auris
Candida glabrata
Candida krusei
Candida parapsilosis
Candida tropicalis
Cryptococcus neoformans/gattii

 
Carbapenemases
IMP
KPC
OXA-48-like
NDM
VIM

Colistin Resistance
mcr-1

ESBL
CTX-M

Methicillin Resistance
mecA/C
mecA/C and MREJ (MRSA)

Vancomycin Resistance
vanA/B

 

Fighting sepsis: a top healthcare challenge today

Early identification and treatment of sepsis is essential to combat one of the leading causes of hospital patient deaths3 [Sepsis Alliance 2018]. The International Guidelines for the Management of Sepsis and Septic Shock recommend empiric broad-spectrum therapy with one or more antimicrobials for patients presenting with sepsis or septic shock to cover all likely pathogens within 1 hour of recognition of the disease4 . However, it is estimated that early empiric antibiotic therapy is inappropriate in about 30% of patients5 . Moreover, it is best practice according to the Guidelines3 to narrow down antimicrobial therapy as soon as pathogens are identified, in order to reduce the occurrence of antimicrobial resistances.

Obtaining rapid blood culture organism identification, combined with the local antibiogram, allows for the timely adjustment of a broad-spectrum empiric antimicrobial therapy to a narrow, targeted patient treatment6.

The BIOFIRE® BCID2 Panel can provide the essential combination of speed, accuracy and comprehensiveness to enable a rapid, definitive identification of a pathogen directly from positive blood cultures..

The potential benefits of fast and comprehensive testing of bloodstream infections may include guided appropriate antibiotic therapy, decreased hospital length of stay7, reduced hospital costs and reduced patient morbidities and mortality.

 


1The stated performance is the aggregate of the prospective data from the clinical study.
2The stated performance is the aggregate of the prospective data from the clinical study.
3Sepsis Alliance: Sepsis Fact Sheet 2018. https://www.sepsis.org/wp-content/uploads/2017/05/Sepsis-Fact-Sheet-2018...
4Rhodes et al., Intensive Care Med. 2017 Mar;43(3):304-377
5Zhang D, et al. Critical Care Medicine 2015;43(10):2133-2140
6Banerjee R, et al. Clinical Infectious Diseases 2015;61:1071-80
7Ray et al. Pediatr Infect Dis J 2016;35:e134-138

Panel Specifications

Sample Handling Performance Parameters
Sample Type: positive Blood Culture media Hands-on time: approximately 2 minutes
Sample Volume: 200 μL Turnaround time: about 1 hour

 

Clinical sensitivity and specificity of the BIOFIRE®  Blood Culture Identification 2 Panel

Pathogen Sensitivity / Positive Percent Agreement (PPA) Specificity / Negative Percent Agreement (NPA)
   
Gram-positive bacteria
Enterococcus faecalis 95.3% 99.8%
Enterococcus faecium 100% 99.8%
Listeria monocytogenes 100% 100%
Staphylococcus 99.8% 98.8%
Staphylococcus aureus 100% 99.9%
Staphylococcus epidermidis 96.5% 96.6%
Staphylococcus lugdunensis 100% 99.8%
Streptococcus 98.4% 99.8%
Streptococcus agalactiae (Group B) 100% 100%
Streptococcus pneumoniae 100% 100%
Streptococcus pyogenes (Group A) 96.7% 100%
   
Gram-negative bacteria
Acinetobacter calcoaceticus-baumannii cp. 97.0% 99.9%
Bacteroides fragilis 100% 99.8%
Enterobacterales 99.8% 95.2%
Enterobacter cloacae complex 100% 100%
Escherichia coli 99.5% 99.9%
Klebsiella aerogenes 100% 100%
Klebsiella oxytoca 100% 100%
Klebsiella pneumoniae group 99.3% 100%
Proteus 100% 99.9%
Salmonella 100% 100%
Serratia marcescens 100% 100%
Haemophilus influenzae 97% 100%
Neisseria meningitidis 100% 100%
Pseudomonas aeruginosa 96.4% 99.9%
Stenotrophomonas maltophilia 88.5% 100%
   
Yeast
Candida albicans 100% 99.9%
Candida auris 100% 100%
Candida glabrata 100% 99.8%
Candida krusei 100% 100%
Candida parapsilosis 96.8% 99.9%
Candida tropicalis 100% 99.9%
Cryptococcus neoformans/gattii 100% 100%

Performance data for the detection of antimicrobial resistance genes can be found in the BioFire Blood Culture Identification 2 Panel Instructions for Use.

This section is currently being updated with the latest medical information which will be made available as soon as possible.

Technical Notes:

Instructions for Use and Manuals:

Product Support Documents:

EC Declarations of conformity:

Please consult your local bioMérieux representative for product availability in your country

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