BioFire Blood Culture Identification (BCID) Panels

BIOFIRE FILMARRAY BLOOD CULTURE IDENTIFICATION 2 (BCID 2) PANEL SYNDROMIC TESTING What is Biofire Filmarray • The FILMARRAY is an FDA-cleared multiplex PCR system that integrates sample preparation, amplification, detection and analysis. It requires just a few minutes of hands-on-time and its turnaround time is just about an hour, giving you faster results which may lead to better patient care. The FilmArray now has five FDA-cleared panels – • Respiratory Panel • pneumonia plus panel • Blood Culture Identification Panel • Gastrointestinal Panel • Meningitis/Encephalitis Panel Together, these panels test for more than a hundred pathogens. Thus, FILMARRAY is not only the fastest way to better results; it’s the fastest way to more results. FilmArray - The Fastest Way to Better Results • Easy: Two minutes of hands-on time • Fast: Results in under 1 hour • Comprehensive: 30+ viral and bacterial pathogens per test • Closed System: Contamination is not an issue • Molecular Diagnostics: Increased sensitivity and specificity • Physicians get answers sooner • Laboratories maximize productivity and reduce costs BioFire ® Blood Culture Identification 2 (BCID2) Panel Testing The BioFire BCID2 Panel is a multiplexed nucleic acid test intended for use with BioFire ® FilmArray ® 2.0 or BioFire ® FilmArray ® Torch Systems for the simultaneous qualitative detection and identification of multiple bacterial and yeast nucleic acids and select genetic determinants associated with antimicrobial resistance. The BioFire BCID2 Panel test is performed directly on blood culture samples identified as positive by a continuous monitoring blood culture system. Results are intended to be interpreted in conjunction with Gram stain results. The following organism types and subtypes are identified using the BioFire BCID2 Panel: Gram-Positive Bacteria • Enterococcus faecalis • Enterococcus faecium • Listeria monocytogenes • Staphylococcus spp. • Staphylococcus aureus • Staphylococcus epidermidis • Staphylococcus lugdunensis • Streptococcus spp. • Streptococcus agalactiae (Group B) • Streptococcus pneumonia • Streptococcus pyogenes (Group A) Gram-Negative Bacteria • Acinetobacter calcoaceticus-baumannii complex • Bacteroides fragilis • Haemophilus influenzae • Neisseria menigitidis (encapsulated) • Psuedomonas aeruginosa • Stenotrophomonas maltophilia Enterobacterales o Enterobacter cloacao Salmonella spp. o Serratia marcescense complex o Escherichia coli o Klebsiella aerogenes o Klebsiella oxytoca o Klebsiella pneumonia group o Proteus spp o Serratia marcescens o Salmonella spp. Yeast • Candida albicans • Candida glabrata • Candida auris • Candida krusei • Candida parapsilosis • Candida tropicalis • Cryptococcus neoformans/gattii Antimicrobial resistance genes • mecA/C • mecA/C and MREJ (MRSA) • vanA/B • KPC • CTX-M • IMP • mcr-1 • VIM • NDM • OXA-48-like The BioFire BCID2 Panel contains assays for the detection of genetic determinants associated with resistance to methicillin (mecA/C and mecA/C in conjunction with MREJ), vancomycin (vanA and vanB), ß-lactams including penicillins, cephalosporins, monobactams, and carbapenems (bla CTX-M , bla IMP , bla KPC , bla NDM , bla OXA48-like, bla VIM ) to aid in the identification of potentially antimicrobial-resistant organisms in positive blood culture samples. In addition, the panel includes an assay for the detection of the mobilized genetic determinant mcr-1, an emerging marker of public health importance. The antimicrobial resistance gene or marker detected may or may not be associated with the agent responsible for disease. Negative results for these select antimicrobial resistance gene and marker assays do not indicate susceptibility, as multiple mechanisms of resistance to methicillin, vancomycin, ß-lactams, and colistin exist. Principle of the BCID 2 Procedure • The BioFire BCID2 Panel pouch is a closed system disposable that stores all the necessary reagents for sample preparation, polymerase chain reaction (PCR), and detection in order to isolate, amplify, and detect nucleic acid from multiple pathogens and antimicrobial resistance genes contained in blood culture samples identified as positive by a continuous monitoring blood culture system. • After sample collection, the user injects hydration solution and sample combined with Sample Buffer into the pouch, places the pouch into a BioFire ® FilmArray ® Instrument module, and starts a run. The entire run process takes about an hour.. During a run, the BioFire System: • Lyses the sample by agitation (bead beating) in addition to chemical lysis mediated by the Sample Buffer. • Extracts and purifies all nucleic acids from the sample using magnetic bead technology. • Performs nested multiplex PCR by: 1.First performing a single, large volume, massively multiplexed reaction (PCR1) 2.Then performing multiple singleplex second-stage PCR reactions (PCR2) to amplify sequences within the PCR1 products • Uses endpoint melting curve data to detect and generate a result for each target on the BioFire BCID2 Panel array. Specimen Type Specimen Blood Culture Samples identified as positive by a continuous monitoring blood culture system. Minimum Sample Volume 0.2 mL (200 µL) Sample Age Specimens should be processed and tested with the BioFire BCID2 Panel as soon as possible after positive bottle indication by a blood culture system. If not processed immediately, specimens can be kept:  At room temperature for up to 24 hours (15-25 °C) after positivity  In the blood culture system for up to 24 hours after positivity Materials Provided Materials Required But Not Provided Each kit contains sufficient reagents to test 30 samples (30-test kit; RFIT-ASY-0147): 1.  Individually packaged BioFire BCID2 Panel Pouches  Single-use (1.0 mL) Sample Buffer Ampoules  Single-use pre-filled (1.5 mL) Hydration Injection Vials (blue)  Single-use Sample Injection Vials (red)  Individually packaged Transfer Pipettes BioFire System including: o BioFire ® 2.0 or BioFire ® Torch systems including one or more modules and accompanying Software o Pouch Loading Station 2. Syringe capable of measuring 0.2 mL (200 µL) sample volume; OR alternate subculture device (e.g. needle-less safe subculture device) and sterile secondary Container. 3. 10% bleach solution or a similar disinfectant Methodology Multiplex Real-Time PCR Assay • These panels test for multiple targets simultaneously • This methodology is real-time PCR meaning that it amplifies and detects at the same time What does this Mean to You? • One sample • One test • Multiple results • 1 hour turnaround time Positive Results Since Implementaion These are just a few… • Limited exposure to potentially hazardous bacterial isolates in blood cultures • Faster treatment and more guided treatment of patients at the point of entry and after admission • Quick diagnosis • Faster antimicrobial therapy implementation to speed recovery and reduce morbidity • Admitting a patient versus not admitting a patient 43 Targets in®One Test The BioFire Blood Culture Identification 2 (BCID2) Panel Positive Culture • The Sample BioFire Type: BCID2 Panel Blood tests for 43 targets associated with bloodstream infections, including gram-negative bacteria, grampositive bacteria, yeast, and 10 antimicrobial resistance genes— all with one test and with results available in about an hour from positive blood culture. Quickly identifying the cause of bloodstream infections and sepsis may help clinicians more rapidly and appropriately manage therapy. Rapid identification of bloodstream pathogens and relevant antimicrobial resistance genes can help reduce the time to appropriate antimicrobial therapy and may positively impact patient survival.