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:
- BIOFIRE® FILMARRAY® Meningitis/Encephalitis Panel
- BIOFIRE® FILMARRAY® Respiratory Panels
- BIOFIRE® FILMARRAY® Gastrointestinal Panel
- BIOFIRE® FILMARRAY® Pneumonia plus Panel
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 ESBL Methicillin Resistance Vancomycin Resistance |
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.
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Publications
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:
- BIOFIRE Blood Culture Identification 2 (BCID2) Panel Quick Guide
- BIOFIRE Blood Culture Identification 2 (BCID2) Panel Quick Guide Safety Data Sheet (SDS)
EC Declarations of conformity: