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VITEK® REVEAL™
RAPID AST FOR BLOODSTREAM INFECTIONS
VITEK® REVEAL™ integrated within the bioMérieux Sepsis Solution enables same-day Antimicrobial Susceptibility Testing (AST) results to help you manage bloodstream infections:
- Delivers phenotypic AST results in an average of 5.5 hours1
- Directly from positive blood culture
- Wide antimicrobial coverage for Gram negative bloodstream infections
Do you need more information?
VITEK® REVEAL™: THE NEW ADDITION TO THE BIOMÉRIEUX SEPSIS SOLUTION
Sepsis management
Predicting antimicrobial resistance (AMR), can be more complex and time-intensive for patients with Gram negative infections.
Early diagnosis and appropriate treatment make a critical difference when it comes to improving sepsis patient outcomes. Hourly delays in antibiotic administration were associated with increased odds of hospital mortality even among patients who received antibiotics within 6 hours.2
The bioMérieux comprehensive Sepsis Solution, with the addition VITEK® REVEAL™, helps to manage your patient therapy all along the pathway bringing you rapid and reliable results to support clinical decisions for better patient care.
Rapid & accurate results direct from blood culture
VITEK® REVEAL™ utilizes Small Molecule Sensors that detects the volatiles released by microorganisms as they grow to quantify antibiotic efficacy. Sensor color changes report growth monitored every 10 minutes, allowing the rapid phenotypic identification of growth or its absence and the associated Minimum Inhibitory Concentration (MIC) determination to be made.
- Real-time monitoring of MIC results
- Up to 176 bug drug combinations
- Allows faster antimicrobial therapy de-escalation to support antimicrobial stewardship
Easily integrated within your lab
Adding VITEK® REVEAL™ to your bioMérieux Sepsis Solution offers you the fastest route to fully actionable results that can support therapy decisions for improved patient outcomes.
- Flexible solution with a modular design to fit any lab
- Access to bioMérieux’s services from consultancy to installation
- Fully integrated sepsis solution from blood culture (BACT/ALERT® VIRTUO®), to identification (BIOFIRE® BCID 2 Panel & VITEK® MS PRIME), AST (VITEK® 2 & VITEK® REVEAL™) and data analysis (MAESTRIA™)
Make an antimicrobial stewardship impact
bioMérieux has made the fight against antimicrobial resistance one of our core priorities throughout more than 55 years of commitment to serving global public health. Building on our leadership position in microbiology, we provide you with a complete microbiology solution designed to increase your workflow efficiency from sample preparation to result interpretation.
1Clinical evaluation of the SPECIFIC REVEAL™/VITEK® REVEAL™ with Gram-negative bacteremia samples in 6 hospitals in France and England - 2021
2Liu VX et al. Am J Respir Crit Care Med. 2017. Vol 196,(7): 856–863
INSTRUMENT
Item | Nominal | Lower Limit |
---|---|---|
Width | 16.7 in (42.4 cm) | NA |
Height | 7.9 in (20.1 cm) | NA |
Depth | 26.9 in (68.3 cm) | NA |
Rear clearance | NA | 5 in (12.7 cm) |
Front clearance | NA | 15 in (38.1 cm) |
Side clearance | NA | 5 in (12.7 cm) |
Weight | 65 lb (29.5 kg) | NA |
SEALER
Item | Nominal | Lower Limit |
---|---|---|
Width | 10 in (25.4 cm) | NA |
Height | 17.3 in (43.9 cm) | NA |
Depth | 21.5 in (54.6 cm) | NA |
Rear clearance | NA | 5 in (12.7 cm) |
Front clearance | NA | 6 in (15.7 cm) |
Side clearance | NA | 5 in (12.7 cm) |
Weight | 75 lb (34 kg) | NA |
SOFTWARE
Item | Nominal | Lower Limit | Upper Limit |
---|---|---|---|
Number of processor modules connected | 3 | 1 | 6 |
Graphical User Interface | 1 display | NA | NA |
User input modes | Keyboard, touch Screen, Mouse, & Barcode Reader | NA | NA |
Resources
Rajeev L, Khomtchouk K, Singh P, Rhodes PA. Detection of carbapenem resistance by the Reveal rapid phenotypic AST assay in strains from the CDC and FDA antimicrobial resistant isolate bank. Poster presented at: ASM Microbe; 2021 June; Anaheim, CA. (PDF)
D Fournier, J Couchot, M Bour, L Rajeev, P Rhodes, P Singh, K Jeannot and P Plésiat. Assessment of the SPECIFIC REVEAL® Rapid AST System in the determination of the sensitivity of Pseudomonas aeruginosa to antibiotics. Poster presented at: 41ème Réunion Interdisciplinaire de Chimiothérapie Anti-Infectieuse (RICAI); 2021 December; Paris, France. (PDF)
Rottman M, Rhodes PA, Singh P, Herrmann JL, Jeannot K, Cattoir V, Carbonnelle E, Plesiat P, Williams A, Dortet L. Clinical evaluation of the SPECIFIC REVEAL™ Rapid AST System with Gram-negative bacteremia samples in 6 hospitals in France and England. Poster presented at: 32nd European Congress of Clinical Microbiology & Infectious Diseases (ECCMID); 2022 May; Lisbon, Portugal. (PDF)
Please consult your local bioMérieux representative for product availability in your country
COMPLETE YOUR SOLUTION
BIOFIRE® SPOTFIRE® Solution
THIS CHANGES EVERYTHING.
As the leader in syndromic testing, bioMérieux presents its new revolutionary offer in Point-of-Care testing with BIOFIRE® SPOTFIRE®:
- Easy to use with an intuitive system interface
- Diagnose the disease quickly and reduce waiting times
- Results with high confidence and high diagnostic yield
Do you need more information?
System Overview
The SPOTFIRE System is bioMérieux’s latest advancement in molecular infectious disease diagnostics and is specifically designed for Point-of-Care testing. All our expertise and cutting-edge FILMARRAY technology is at the heart of the system design.
The SPOTFIRE System offers:
- The ability to run PCR syndromic tests on 1,2,3 or 4 modules and automated molecular results in minutes
- An intuitive touchscreen with guided operation, integrated barcode reader, POCT connectivity and easy printer setup
- All the materials needed to run a test for a complete peace of mind
The SPOTFIRE workflow is straightforward with its easy sample and reagent preparation that allows onsite testing and without storage constraints (Room Temperature reagent storage).
Small and Modular
Minimal benchtop space required and can be vertically scaled up for a customizable throughput
Fully automated
Sample to result system with bi-directional connectivity (POCT01-A2) for effortless data transfer and seamless reporting
Boosted flexibility
Modules random access to run up to 4 tests at the same time
Easy to use
With an intuitive system interface and streamlined workflow allowing usage by healthcare professionals, at any time, in healthcare settings
bioMérieux Support
Make the most of your SPOTFIRE investment
Our goal is to provide you with the best support available while minimizing any disruption to your workflow
- bioMérieux offers best-in-class application and engineering services
- A skilled team is dedicated to your success providing global product support, solution training courses, connectivity assistance, and instrument or chemistry related troubleshooting
BIOFIRE® SPOTFIRE® Respiratory Panels
Syndromic multiplex PCR tests developed for Point-of-Care testing.
Respiratory tract infections are a significant cause of morbidity and mortality, and they exact a huge economic cost across the world.
Testing for more than flu, RSV, and SARS-CoV-2 with one test provides healthcare professionals with the full picture and may timely impact patient therapy and management decisions.
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BIOFIRE® SPOTFIRE® RESPIRATORY/SORE THROAT (R/ST) PANEL* 1 PCR Test. 2 Uses. 15 Targets. ~15 Minutes. |
RESPIRATORY | |
VIRUSES Adenovirus Influenza A virus A/H1-2009 Influenza B virus |
BACTERIA Bordetella parapertussis |
SORE THROAT | |
VIRUSES Adenovirus Influenza A virus A/H1-2009 Influenza B virus |
BACTERIA Chlamydia pneumoniae |
*CE2797
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BIOFIRE® SPOTFIRE® RESPIRATORY (R) PANEL** 1 PCR Test. 15 Targets. ~15 Minutes. |
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
**FDA CLEARED | CLIA WAIVED
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BIOFIRE® SPOTFIRE® RESPIRATORY (R) PANEL MINI*** 1 PCR Test. 5 Targets. ~15 Minutes. |
VIRUSES
Coronavirus SARS-CoV-2
Human rhinovirus
Influenza A virus
Influenza B virus
Respiratory syncytial virus
***FDA CLEARED | CLIA WAIVED
Experience the benefits of Syndromic Testing at Point-of-Care
Due to the similarity of diseases caused by multiple pathogens, diagnosis based on clinical symptoms alone is difficult.
What is Syndromic Testing?
Symptoms + Signs = Syndrome
Syndromic testing is the process of using one test to simultaneously target multiple pathogens with overlapping signs and symptoms.
What are the benefits of Syndromic Testing?
Rapid and comprehensive results may eliminate the need for follow-up testing or for sending tests out to a reference lab. Syndromic testing from BIOFIRE® SPOTFIRE® can help inform timely treatment decisions and may reduce the use of unnecessary antibiotics.
All-in-one and effortless workflow
System Environmental Specifications
- 15-30°C @ 15-80% relative humidity (non-condensing)
- -16 m (-50 ft.) to 3,048 m (10,000 ft.) operating altitude
- Indoor, stationary use only
Reagent Environmental Specifications
- Storage at room temperature (BIOFIRE SPOTFIRE Respiratory Panels)
Please consult your local bioMérieux representative for product availability in your country
APIWEB™
On-line bacteria and yeast database
On-line bacteria and yeast database accessible worldwide anytime, anywhere, for everyone.
- User-friendly
- Reliable complement to manual identification for relevant patient management
- Easy to use
- Secure connection
Do you need more information?
Committed to remaining at the forefront of innovation, bioMérieux brings a new dimension to the reference API® biochemical test strip range by making identification available to everyone, anytime, anywhere. A tool that leverages the technologies of today and tomorrow, APIWEB™ is the essential complement to manual identification.
User-friendly
APIWEB™ – it’s as simple as navigating in a webpage!
- Internet platform
- Easy-to-use integrated intuitive interface that uses Internet navigation tools
- Available anytime 24/7
- Reading assistance for each identification strip
See how easy is it to use? Watch these videos done by our API® customers
Reliable complement to manual identification
For years, the API® ID strip range has been appreciated by microbiologists over the world for its quality and ease-of-use. In fact, the standardized, miniaturized strips of biochemical tests are the reference for bacterial and fungal identification. API® has a wide identification database on the market and a numerical identification calculation method that brings standardization and makes identification easy and accurate.
Considering that 10 API® strips are used every minute, APIWEB™ is an invaluable tool for the microbiology community.
Get high-performance results
With APIWEB™, you get a reliable, state-of-the-art interpretation tool. It contains the regularly updated API®/ID32 databases. Plus, APIWEB™ interprets a great number of profiles enabling the identification of more than 700 species of bacteria and yeast. It’s the straightforward and easy way to get high-performance results!
Each identification includes a complete report:
- Species proposed
- Comment on the reliability of the identification, based on two indices:
- the identification percentage (probability of species identification)
- the typicity index (typical character of the profile studied)
- Complete biochemical profile
- Additional information and tests
Secure connection
Your privacy as a user and the confidentiality of your results are important to us. That’s why we’ve made sure that APIWEB™ is protected by full security.
- Secure site, personalized access codes
- Data encoding to ensure the integrity and confidentiality of your results
- Highly reactive tool maintenance
Please consult your local bioMérieux representative for product availability in your country
COMPLETE YOUR SOLUTION
BIOFIRE® FILMARRAY® Pneumonia plus Panel
The BIOFIRE FILMARRAY Pneumonia plus Panel enables rapid and accurate automated testing for 27 bacteria and viruses that cause pneumonia and other lower respiratory tract infections (LRTI), as well as for 7 genetic markers of antibiotic resistance.
- Simple: 2 minutes of hands-on time
- Easy: No precise measuring or pipetting required
- Fast: Turnaround time of about an hour
- Comprehensive: Simultaneously tests for 34 targets
Do you need more information?
Simple, comprehensive pneumonia and LRTI testing
The BIOFIRE® FILMARRAY® Pneumonia plus Panel tests for 18 bacteria (11 Gram negative, 4 Gram positive and 3 atypical), 7 antibiotic resistance markers, and 9 viruses that cause pneumonia and other lower respiratory tract infections. It offers an overall sensitivity and specificity for bronchoalveolar (BAL)-like samples of 96,2% and 98.3%, respectively, and for sputum samples a sensitivity and specificity of 96.3% and 97.2%, respectively. The BIOFIRE® FILMARRAY® Pneumonia plus Panel is run on the BIOFIRE® FILMARRAY® System, a US FDA, CE-IVD, and TGA certified multiplex PCR system. The system integrates sample preparation, nucleic acid extraction and purification, amplification, detection and analysis into one simple system that requires just 2 minutes of hands-on time, with a total run time of about one hour.
The new panel complements the existing BIOFIRE® FILMARRAY® Respiratory 2 plus Panel to provide a comprehensive diagnostic tool for pneumonia and other lower respiratory tract infections. For, A rapid and accurate identification of the causative agent of both community and health care associated respiratory infections can help improve patient management by informing timely and effective antibiotic or antiviral therapy. A rapid diagnosis can assist with directing appropriate infection control practices thereby aiding in the prevention of secondary spread of infection, shorten hospital stays, reduce ancillary testing, and reduceoverall health care costs.
- Simple: 2 minutes of hands-on time
- Easy: No precise measuring or pipetting required
- Fast: Turnaround time of about an hour
- Comprehensive: 34-target pneumonia panel
The BIOFIRE® FILMARRAY® Pneumonia plus Panel and the BIOFIRE® FILMARRAY® Pneumonia Panel are one of five FDA-cleared and CE-marked panels for use on the BIOFIRE® FILMARRAY® multiplex PCR system. Taken together, the five BIOFIRE® FILMARRAY® Panels comprise the largest infectious disease pathogen menu commercially available. The other available panels are:
- BIOFIRE® FILMARRAY® Meningitis Encephalitis (ME) panel
- BIOFIRE® FILMARRAY® Blood Culture Identification Panel (BCID) panel
- BIOFIRE® FILMARRAY® Gastrointestinal (GI) panel
- BIOFIRE® FILMARRAY® Respiratory Panels (RP) panels
- BIOFIRE® Joint Infection (JI) Panel
34 targets at once
The BIOFIRE® FILMARRAY® Pneumonia plus Panel is incredibly comprehensive, with simultaneous testing for 27 of the most common pathogens involved in LRTI and 7 genetic markers of antibiotic resistance.
Bacteria (semi quantitative) | Antibiotic Resistance Genes |
---|---|
Acinetobacter calcoaceticus-baumannii complex
Enterobacter cloacae
Escherichia coli
Haemophilus influenzae
Klebsiella aerogenes
Klebsiella oxytoca
Klebsiella pneumoniae group
Moraxella catarrhalis
Proteus spp.
Pseudomonas aeruginosa
Serratia marcescens
Staphylococcus aureus
Streptococcus agalactiae
Streptococcus pneumoniae
Streptococcus pyogenes
|
ESBL
CTX-M
Carbapenemases
KPC
NDM
Oxa48-like
VIM
IMP
Methicilin Resistance
mecA/mecC and MREJ
|
Atypical Bacteria (Qualitative) | Viruses |
---|---|
Legionella pneumophila
Mycoplasma pneumoniae
Chlamydia pneumoniae
|
Influenza A
Influenza B Adenovirus
Coronavirus
Parainfluenza virus
Respiratory Syncytial virus
Human Rhinovirus/Enterovirus
Human Metapneumovirus
Middle East Respiratory Syndrome Coronavirus (MERS-CoV)*
* MERS-CoV will only be available on the Pneumonia Panel plus
|
Pneumonia: A leading cause of mortality globally
“Lower respiratory infections remained the most deadly communicable disease, causing 3.0 million deaths worldwide in 2016.” 1
Lower respiratory tract infections (LRTI) including pneumonia are considered the third leading cause of death worldwide, and the most deadly communicable disease.1 The severity of pneumonia can range from mild to severe– and is particularly dangerous for people who are very young, elderly, have co-morbidities such as asthma or chronic obstructive pulmonary disease (COPD) or immunocompromised. A number of pathogens cause pneumonia, including viruses, bacteria and fungi. Streptococcus pneumoniae is the most common cause of bacterial pneumonia, followed by Haemophilus influenzae type b (Hib). Respiratory syncytial virus (RSV) and the influenza virus are the first and second most common causes of viral pneumonia. 1,2
Pneumonia can be difficult to diagnose because the typical symptoms – shortness of breath, weakness, high fever, coughing, and fatigue – can also signal other illnesses, and the symptoms may not be pathogen specific..2, Aside from the symptoms, x-rays, demographic information and identification of potential causative agents are important for making a diagnosis of pneumonia . Inappropriate antibiotic treatment for pneumonia is common, in part because it is often treated empirically without determining the cause,.3,4 This contributes to longer hospital stays and higher costs, as well as to the development of antimicrobial resistance.
References:
- WHO Top 10 causes of death 2016: http://www.who.int/en/news-room/fact-sheets/detail/the-top-10-causes-of-...
- WHO Pneumonia fact sheet 2016: http://www.who.int/news-room/fact-sheets/detail/pneumonia
- Fleming-Dutra, K.E. et. al. “Prevalence of Inappropriate Antibiotic Prescriptions Among US Ambulatory Care Visits, 2010-2011”. JAMA. 2016;315(17):1864-1873
- Biscevic-Tokic J., et. al. “Pneumonia as the Most Common Lower Respiratory Tract Infection”. Med Arch. 2013 Dec; 67(6): 442–445
Panel Specification
Sample Handling | Performance Parameters |
---|---|
Sample Type:
Sputum-like : Induced and expectorated Sputum; Endotracheal aspirates.
BAL-like : BAL and mini-BAL
|
Hands-on time: Approx. 2 minutes
|
Sample Volume: 200 μL collected with a flocked swab | Run time: About an hour |
Our Solutions
- Emergency Department patient management Solutions page
- Antimicrobial Resistance Management Solutions page
Publications
- Buchan B, et al. Practical Comparison of the BioFire FilmArray Pneumonia Panel to Routine Diagnostic Methods and Potential Impact on Antimicrobial Stewardship in Adult Hospitalized Patients with Lower Respiratory Tract Infections. J Clin Microbiol 2020; 58(7): e00135-20
- Monard C, et al. Multicenter evaluation of a syndromic rapid multiplex PCR test for early adaptation of antimicrobial therapy in adult patients with pneumonia. Crit Care 2020; 24(1): 434
- Webber DM, et al. Evaluation of the BioFire FilmArray Pneumonia Panel for Detection of Viral and Bacterial Pathogens in Lower Respiratory Tract Specimens in the Setting of a Tertiary Care Academic Medical Center. J Clin Microbiol. 2020;58(7):e00343-20
- Verroken A, et al. Co-infections in COVID-19 critically ill and antibiotic management: a prospective cohort analysis. Crit Care 2020;24(1):410
- Maataoui N, et al. Impact of rapid multiplex PCR on management of antibiotic therapy in COVID-19-positive patients hospitalized in intensive care unit o-infections in COVID-19 critically ill and antibiotic management: a prospective cohort analysis. Eur J Clin Microbiol Infect Dis. 2021 Mar 17;1-8
Secondary Bacterial Infections in COVID-19 Patients:
Is widespread antibiotic use really necessary?
In this presentation, Pr David Livermore (Professor of Medical Microbiology, University of East Anglia, UK) and Dr David Brealey (Critical care consultant, University College London Hospital, UK) will discuss the rationale for empiric antibiotic prescriptions in COVID-19 patients and the current evidence on secondary infections. They will share their experience with the incorporation of a rapid diagnostic assay in the treatment algorithm of COVID-19 patients, and how this impacted patient management. Finally, the experts will present their learnings from the first wave of the pandemic, and share their viewpoints on a potential second wave.
Impact of a multiplex PCR assay on antibiotic prescription in COVID-19 patients in the ICU
In this symposium, Dr Louis Kreitmann (Dept. of Intensive Care Medicine, Hôpital Edouard Herriot, Lyon, France) presents results of a recently published study in patients with confirmed SARS-CoV-2 infections requiring invasive mechanical ventilation for ARDS. The study revealed a high rate of early bacterial coinfections in these patients, as illustrated by a clinical case. A multiplex PCR assay was used to identify causative bacterial pathogens early on, which allowed to optimize antibiotic treatment in these COVID-19 patients.
The value of rapid Syndromic Testing in the early adjustment of empiric antibiotic treatment for pneumonia patients
In this symposium presented at ESICM 2019, Dr Ilias Karaiskos, MD, PhD (Internal Medicine-Infectious Diseases, Hygeia General Hospital, Athens, Greece) discusses the role of traditional microbiology testing in the diagnosis of CAP, HAP and VAP patients. Dr Karaiskos shows that international guidelines started to recommend molecular techniques as preferred diagnostic approach for the early detection of some pneumonia-causing pathogens. The lecturer then uses recently published study data as well as real-life patient cases to illustrate the clinical benefits linked to rapid Syndromic Testing in the care of pneumonia patients.
Please consult your local bioMérieux representative for product availability in your country
COMPLETE YOUR SOLUTION
VITEK® MS PRIME
New-generation mass spectrometry microbial identification system
Take your mass spectrometry to the next level! With its all-new design, the VITEK® MS PRIME MALDI-TOF (Matrix Assisted Laser Desorption Ionization-Time of Flight) system for routine microbial identification enhances productivity for faster time to results and improved patient management.
- Superior workflow and seamless connectivity with VITEK® 2 AST
- Robust & accurate single-choice identifications in minutes
- Supports earlier optimized antimicrobial therapy for patient care and AMS
- Backed by 55 years of microbiology expertise
Do you need more information?
VITEK® MS PRIME: designed to maximize routine workflow efficiency
VITEK® MS PRIME is intelligently designed for superior workflow efficiency. Its time-saving innovations deliver faster identification results. Enhance your productivity further through seamless integration with VITEK® 2 AST results to provide earlier targeted patient therapy and support Antimicrobial Stewardship (AMS).
Designed for maximized productivity & uptime
- Automated continuous Load & Go:
- Load up to 16 slides without impact on samples currently processing
- End-to-end sample traceability with automatic barcode scanning
- Unload slides individually or by batch on demand
- One-click urgent slide prioritization, with automatic resumption of regular analysis
- All new inside: Lifetime laser*, long-lasting linear detector, pioneering ion optic design and automated fine-tuning
- Initiate automatic fine-tuning when instrument not in use; hands-free maintenance
- Benchtop system: Easily integrates into your lab with space-saving design and on-board, adjustable PC
*up to 100 billion shots
Built on microbiology expertise
Robust and evolving database
- Single-choice results at the species, genus, or group level in minutes
- An average of 12 strains per species for microbial variability
- Database regularly updated with emerging species and taxonomy changes
Foundation of Workflow efficiency
- Fast, easy protocols including on-slide sample prep for bacteria and yeast with VITEK® PICKMETM (or a loop)
- Ready-to-use kits for mycobacteria, nocardia and moulds
- Preparation and results review at any bench
Fits the lab for seamless ID & AST
- Direct link with VITEK® 2 AST for faster results
- Integration brings additional traceability and flexibility
- Lab data converted into actionable insights with MYLA® and middleware
Service and support from a committed partner
- By your side from installation and integration to daily operations
- Expert lab consultancy to optimize adoption and processes
- Microbiology expertise with 55+ years of experience
Helping your lab make a difference in AMS
In a world of ever-challenging Antimicrobial Resistance, bioMérieux is your committed partner for Antimicrobial Stewardship (AMS). By putting diagnostics at the heart of AMS, labs help drive informed decisions. Count on bioMérieux to provide your laboratory with the most up to date and complete AMS solution to fight resistance and help sustain antibiotics for future generations.
VITEK® MS PRIME further strengthens your capacity to support AMS. By reporting ID results even faster, you help drive informed clinical decisions that optimize antibiotic patient therapy earlier.
VITEK® PICKME™
Just 4 steps for simple, standardized sample prep
Make sample preparation for VITEK® MS easier, streamlined and more standardized with the new VITEK® PICKME™.
Designed by microbiology experts, VITEK® PICKME™ looks like a pen and is just as easy to use. Its disposable nib lets you easily pick up a colony just by contact and then smear a thin layer onto the VITEK® MS-DS target slide spot. The nib is then hygienically ejected directly into an appropriate waste container.
- Significant time savings for sample spot preparation
- Reduced variability among users
- “Mucoid” and “dry” colonies considerably easier to deposit (vs. loops)
- Improved homogeneity and thinner deposit, even for very mucoid colonies
Please consult your local bioMérieux representative for product availability in your country
Complete your solution
VITEK® SOLUTIONS
Complete automated ID/AST platform
The only completely integrated platform for identification and antimicrobial susceptibility testing, designed to move microbiology forward.
- Provide accurate ID/AST results faster
- Simplify workflow & improve operational efficiency
- Provide clinicians with results in minimal time for quicker therapeutic decisions
Do you need more information?
VITEK® SOLUTIONS: The truly complete ID/AST solution
Early and appropriate antibiotic therapy is essential to improve overall patient care and reduce healthcare costs in the context of constantly evolving bacterial resistance. VITEK® SOLUTIONS offer the truly complete automated platform for identification and antimicrobial susceptibility testing (ID/AST). Designed by microbiologists for microbiologists, VITEK® MS and VITEK® 2 provide the flexibility you need to optimize laboratory workflow. Plus, MYLA® software allows you to oversee the entire process in real-time from any device.
VITEK® SOLUTIONS enable you to confidently deliver results with excellent speed and accuracy – whether you are faced with routine diagnoses, unusual or resistant organisms, or critical clinical situations. The combined SOLUTIONS have been shown to get results to clinicians 14 to 20 hours earlier1,2,3, facilitating clinical decision-making for optimal treatment. This also saves healthcare costs: VITEK® MS ID saves labs about 50% compared to traditional ID methods, and same-day AST reporting with VITEK® 2 can reduce hospital costs as much as 40%3,5. VITEK® SOLUTIONS are moving microbiology forward.
VITEK® MS: ID in minutes
The VITEK® MS automated mass spectrometry microbial identification system provides clear identification at the species, genus and family level in just minutes1,2,3,4.
- bioMérieux’s unique proprietary algorithm, the Advanced Spectra Classifier, provides better discrimination, even for closely-related species
- Robust results with a population-built IVD-CE marked and US-FDA cleared bacterial & yeast database that accounts for diversity within the same species
- IVD CE marked database is the world’s first to include mycobacteria, Nocardia and moulds
- Boost productivity, safety and performance with reagents and accessories designed specifically for microbial identification
- ID results are automatically pushed to VITEK® 2 through MYLA® software, which also allows accessibility from most devices
VITEK® 2: Because time matters in AST
VITEK® 2 microbial ID/AST testing system combines an innovative, automated platform with an expansive database of clinically significant organisms. ID results arrive automatically from VITEK® MS through MYLA® software, so AST can be promptly linked to the ID. The system uses ready-to-use AST cards that make test setup simple and can offer results in as little as 5 hours8. It also helps improve overall laboratory workflow: fewer repetitive tasks, enhanced safety, improved standardization, and rapid time-to-results and reporting.
The VITEK® 2 Advanced Expert System™ automatically reviews every result and flags those that require a microbiologist’s expertise. The others – the majority of results - can be quickly and automatically reported to the clinician freeing up microbiologists’ time and giving clinicians critical information for appropriate antibiotic therapy sooner3,6.
Extended flexibility, optimized workflow
VITEK® MS and VITEK® 2 together provide the solution for complete and seamless integration for same-day ID/AST results. But the flexibility doesn’t end there. MYLA® connectivity lets you follow sample processing, obtain data in real-time, monitor your lab from a single dashboard and report results rapidly. VITEK® SOLUTIONS can adapt to any size or type of lab, thanks to different size options (120-card or 60-card versions of VITEK® 2) and the ability to connect multiple VITEK® MS and VITEK® 2 instruments to operate from a single PC. Whatever setup you choose, you gain the benefits of optimized workflow and operational efficiency:
- High throughput
- Reduced hands-on time – up to 50% fewer steps7,8
- Less reagent handling
- Barcodes on reagents and disposables automatically link ID with AST results of each isolate
- Less manual data entry with automated transfer of ID results for AST result interpretation
- Quick and easy reviewing and reporting – results available anywhere, anytime through MYLA® software, with numerous customizable data management functions including real-time connectivity with your existing LIS
- Create and follow epidemiology results with a customizable and flexible solution anywhere, anytime through MYLA® software
Confidence with complete traceability
VITEK® SOLUTIONS ensure complete traceability to contribute to overall lab efficiency and confidence.
- Pre-applied barcodes on reagents and disposables automatically link ID with AST results of each isolate
- Patient and sample information are linked from sample setup through final reporting
- Results and system information easily accessed remotely
- Parallel sample preparation by multiple microbiologists at different locations or benches
Sources:
1) Kaleta and Wolk, Clin Lab News ; May 2012
2) Barenfanger et al. JCM 1999 37 (5) 1415
3) Galar et al. EJMID 2012 31 (9) 2445
4) Eigner et al. JCM August 2005 43 (8) 3829
5) Mitchel et al. JCM 2015 53 (8) 2473
6) Ayats J., et. al. ASM 2007
7) Heller-Ono A. bioMerieux® White Paper, 2008
8) Römmler W., et al. ASM 2006; Poster C-123.
VITEK® MS Technical Data
Laser
- 337 nm nitrogen laser, fixed focus
- Maximum pulse rate - 50 Hz (50 laser shots per second)
- Near normal (on-axis) incidence of the laser beam to the sample
- Laser power and laser aim under software control
Analyzer
- Linear flight tube of 1.2 m drift length
- Vacuum maintained by two turbomolecular pumps (nominal 250 l/s) with rotary backing
- Beam blanking to deflect unwanted high intensity signals e.g. matrix ions
Dimensions
- Size (w h d) - 0.7 m x 1.92 m x 0.85 m, minimum distance to wall at back is 100 mm
- Weight - 330 kg excluding data system
Installation Requirements
- Electrical
- 200 VAC, 50/60 Hz, 1000 VA single phase OR
- 230 VAC, 50/60 Hz, 1000 VA single phase
- A ‘clean’, stable and continuous main supply is required for reliable operation
- Temperature - ambient 18° to 26° C
- Relative humidity - less than 70% non condensing
- Vibration free, firm, level floor, at least 330 kg supported at four points
Mass Range
1 to 500 kDa
Also available: VITEK® MS Plus for complete coverage providing access to IVD and RUO databases
VITEK® 2 Technical Data
Weight:
- VITEK® 2 (60 card capacity): 110 kg/240 lbs
- VITEK® 2 XL (120 card capacity): 145 kg/320 lbs
Electrical Power Requirements:
- 110/120 VAC (50-60 Hz)
- 220/240 VAC (50-60 Hz)
Heat Dissipated:
- VITEK® 2: 512 BTU/Hr. (nominal)
- VITEK® 2 XL: 632 BTU/Hr/ (nominal)
Environmental Requirements:
- Operating Ambient Temperature Range: 20°C to 30°C (68°F-86°F)
- Operating Humidity Range: 20% to 80% relative humidity, non-condensing
Altitude:
- Up to 2000 meters
Please contact your local bioMérieux representative for product availability.
Please consult your local bioMérieux representative for product availability in your country
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BIOFIRE® Respiratory 2.1 plus (RP2.1plus) Panel
The new BIOFIRE® Respiratory 2.1 plus Panel enables rapid and accurate automated detection of pathogens behind respiratory infections. It tests for 19 viruses including SARS-CoV-2, and 4 bacteria that cause respiratory tract infections in 45 min.
- Simple: 2 minutes of hands-on time
- Fast: Turnaround time of 45 minutes for RP2.1 plus
- Comprehensive: 23 targets including viruses and bacteria
- Accurate: Overall 97.1% sensitivity and 99.3% specificity (prospective specimens) *1 SARS-CoV-2 98.4% PPA and 98.9% NPA*2
1: Based on the prospective portion of the clinical study for the BIOFIRE® FILMARRAY® Respiratory 2 Panel
2: Overall performance based on prospective SARS-COV-2 clinical study for the BIOFIRE® Respiratory 2.1 Panel in comparison to 3 EUA tests, Data on file, BIOFIRE Diagnostics.
Do you need more information?
Simple, comprehensive respiratory testing
1 Test. 23 Targets. ~45 Minutes.
The BIOFIRE RP2.1 plus Panel uses a syndromic approach to accurately detect and identify the pathogens most commonly associated with respiratory infections. Fast and comprehensive, the BioFire RP2.1 Panel offers a run time of about 45 minutes, enabling high efficiency and throughput on the BIOFIRE® FILMARRAY® 2.0 and the BIOFIRE® FILMARRAY® Torch Systems. Rapid respiratory PCR test results may enable better-informed diagnosis and treatment of patients. Quick turnaround on a broad menu of pathogens may also help clinicians make vital decisions regarding admission, isolation, cohorting, and additional diagnostic testing.
- Simple: 2 minutes of hands-on time
- Easy: No precise measuring or pipetting required
- Fast: Turnaround time of about 45 minutes
- Comprehensive: 23 target respiratory panel
BIOFIRE® Respiratory 2.1 plus Panel is one of six FDA-cleared and/or CE-marked panels for use on the BIOFIRE® FILMARRAY® multiplex PCR system. Taken together, the six BIOFIRE® panels comprise the largest infectious disease pathogen menu commercially available. The other available panels are:
- BIOFIRE® FILMARRAY® ME panel
- BIOFIRE® FILMARRAY® BCID2 panel
- BIOFIRE® FILMARRAY® GI panel
- BIOFIRE® FILMARRAY® Pneumonia plus Panel
- BIOFIRE® Joint Infection (JI) Panel
The BIOFIRE RP 2.1 plus Panel Menu
Viruses | Bacteria | |
Adenovirus Coronavirus 229E Coronavirus HKU1 Coronavirus NL63 Coronavirus OC43 Middle East respiratory syndrome coronavirus (MERS-CoV) Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Human metapneumovirus Human rhinovirus/enterovirus Influenza A virus Influenza A virus A/H1 Influenza A virus A/H3 Influenza A virus A/H1-2009 Influenza B virus Parainfluenza virus 1 Parainfluenza virus 2 Parainfluenza virus 3 Parainfluenza virus 4 Respiratory syncytial virus |
Bordetella parapertussis Bordetella pertussis Chlamydia pneumoniae Mycoplasma pneumoniae |
Improve Clinical Outcomes
The BIOFIRE® FILMARRAY® Respiratory Panels have has been shown to significantly reduce ICU days3 and duration of antibiotic use.4 Optimize patient management with clinically actionable results.
3. Martinez R, et al. Clinical Virology Symposium, Poster #C-368, May 2016.
4. Rogers B, et al. Arch. Path. & Lab. Med. 2015;139(5): 636-41.
Panel Specification
Sample Handling | Performance Parameters |
---|---|
Sample Type: Nasopharyngeal Swab | Hands-on time: Approx. 2 minutes |
Sample Volume: 300 μL | Run turnaround time: ~45 minutes |
Clinical Outcomes PUBLICATIONS
- Impact of Early Multiplex FilmArray Respiratory Pathogen Panel (RPP) Assay on Hospital Length of Stay in Pediatric Patients Younger Than 3 Months Admitted for Fever or Sepsis Workup
- Impact of multiplex molecular assay turn-around-time on antibiotic utilization and clinical management of hospitalized children with acute respiratory tract infections
- Clinical impact of rapid molecular detection of respiratory pathogens in patients with acute respiratory infection
- Routine molecular point-of-care testing for respiratory viruses in adults presenting to hospital with acute respiratory illness (ResPOC): a pragmatic, open-label, randomised controlled trial
- Impact of Multiplex Polymerase Chain Reaction Testing for Respiratory Pathogens on Healthcare Resource Utilization for Pediatric Inpatients.
- Impact of a rapid respiratory panel test on patient outcomes.
- Rapid respiratory panel testing influences patient management and clinical outcomes.
- Implementation of FilmArray respiratory viral panel in a core laboratory improves testing turnaround time and patient care.
- Comparison of turnaround time and time to oseltamivir discontinuation between two respiratory viral panel testing methodologies.
- Seasonality and prevalence of respiratory pathogens detected by multiplex PCR at a tertiary care medical center.
POSTERS
- Clinical Outcomes Among Febrile Infants Before and After Implementation of BioFire® FilmArray® Panels
- Impact of Multiplex Polymerase Chain Reaction Testing for Respiratory Pathogen Detection in Pediatric Patients
- Comparison of Turnaround Time (TAT) and Time to Oseltamivir Discontinuation between Two Respiratory Viral Panel Testing (RVP) Methodologies
- Utilization and Impact of Rapid Respiratory Virus Panel Testing on Evaluation and Managment of Children Seen in a Pediatric Emergency Department
Economic Outcomes PUBLICATIONS
- Clinical impact of rapid molecular detection of respiratory pathogens in patients with acute respiratory infection
- Impact of a rapid respiratory panel test on patient outcomes.
- Rapid respiratory panel testing influences patient management and clinical outcomes.
- Implementation of FilmArray respiratory viral panel in a core laboratory improves testing turnaround time and patient care.
- Comparison of turnaround time and time to oseltamivir discontinuation between two respiratory viral panel testing methodologies.
POSTERS
Performance PUBLICATIONS
- Multicenter Evaluation of the BioFire FilmArray Respiratory Panel 2 for the Detection of Viruses and Bacteria in Nasopharyngeal Swab Samples.
- Point-Counterpoint: Large multiplex PCR panels should be first line tests for detection of respiratory and intestinal pathogens
- Impact of Multiplex Polymerase Chain Reaction Testing for Respiratory Pathogens on Healthcare Resource Utilization for Pediatric Inpatients
- Impact of a rapid respiratory panel test on patient outcomes.
- Rapid respiratory panel testing influences patient management and clinical outcomes.
- FilmArray, an automated nested multiplex PCR system for multi-pathogen detection: development and application to respiratory tract infection.
- Implementation of FilmArray respiratory viral panel in a core laboratory improves testing turnaround time and patient care.
- Comparison of turnaround time and time to oseltamivir discontinuation between two respiratory viral panel testing methodologies.
- Seasonality and prevalence of respiratory pathogens detected by multiplex PCR at a tertiary care medical center.
- For respiratory virus detection, a golden age.
POSTERS
- Real-Time Monitoring of Respiratory Illness During Flu Season
- Analytical Studies for FilmArray®: A Rapid and Easy-to-Use Platform for Molecular Detection of Respiratory, Blood, and Gastrointestinal Pathogens.
Fast facts on Respiratory Pathogens
What are Respiratory Pathogens?
The vast majority of respiratory illnesses are caused by viruses and bacteria. In both children and adults, acute respiratory infections (ARI) are most frequently due to infections with Influenza A and B viruses, Parainfluenza viruses 1, 2 and 3, Respiratory Syncytial Virus (RSV A and B), Adenoviruses and Rhinoviruses. Others pathogens such as Coronaviruses, Bocaviruses, Enteroviruses, Parainfluenza 4, Human Metapneumovirus, Mycoplasma pneumonia and Chlamydophila pneumoniae also infect the respiratory tract and can cause various diseases from mild self-limiting upper respiratory infections to potentially threatening pneumonia.
Who is most at risk?
Anyone can become infected and ill with these respiratory pathogens. However, young children, the elderly, immunocompromised or weakened individuals (including those with chronic disease, cancer, or in intensive care) are most likely to suffer serious and potentially life-threatening pneumopathies.
What are the benefits of Respiratory pathogens molecular testing?
Clinical symptoms for different respiratory illnesses are similar so in vitro diagnostic molecular methods are necessary to determine the causative agents. Early, rapid and specific detection of the virus or bacteria involved using real-time PCR methods is essential to provide patient-tailored therapy for better outcomes. An accurate diagnosis may also help to control outbreaks, reduce potential antibiotic resistance and facilitate a more rapid patient recovery.
Technical Notes and Advisory Notes:
- Guidelines for Laboratory Verification of Performance of the BIOFIRE® FILMARRAY® Respiratory Panel (RP)
- Contamination Prevention & Decontamination
- Bordetella pertussis Advisory Notice
Instructions for Use and Manuals:
- BIOFIRE® FILMARRAY® Respiratory 2.1 plus Panel (RP2.1plus) Instruction Booklet, FAIV
Product Support Documents:
- BIOFIRE® FILMARRAY® Respiratory 2.1 plus Panel Quick Guide
EC Declarations of conformity:
Please consult your local bioMérieux representative for product availability in your country
COMPLETE YOUR SOLUTION
BIOFIRE® Blood Culture Identification 2 (BCID2) Panel
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.
Do you need more information?
Simple, comprehensive pathogen ID from blood cultures
The BIOFIRE® Blood Culture Identification 2 (BCID2) Panel tests for a comprehensive list of 43 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. BIOFIRE BCID2 panel 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.
The BIOFIRE® BCID2 panel is one of six FDA-cleared and CE-marked panels for use on the BIOFIRE® systems. Taken together, the BIOFIRE® 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
- BIOFIRE® Joint Infection Panel
2The stated performance is the aggregate of the prospective data from the clinical study.
BIOFIRE® BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL
1 Test. 43 Targets. ~1 Hour.
GRAM-NEGATIVE BACTERIA | GRAM-POSITIVE BACTERIA |
Acinetobacter calcoaceticusbaumannii complex Bacteroides fragilis Enterobacterales Enterobacter cloacae complex Escherichia coli Klebsiella aerogenes Klebsiella oxytoca Klebsiella pneumoniae group Proteus spp. Salmonella spp. Serratia marcescens Haemophilus influenzae Neisseria meningitidis Pseudomonas aeruginosa Stenotrophomonas maltophilia |
Enterococcus faecalis Enterococcus faecium Listeria monocytogenes Staphylococcus spp. Staphylococcus aureus Staphylococcus epidermidis Staphylococcus lugdunensis Streptococcus spp. Streptococcus agalactiae Streptococcus pneumoniae Streptococcus pyogenes |
Yeast | Antimicrobial Resistance Genes |
Candida albicans Candida auris Candida glabrata Candida krusei Candida parapsilosis Candida tropicalis Cryptococcus (C. neoformans/C. 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 |
Our Solutions
Publications
Testimonials
Watch Dr Hani Shukri’s testimonial on the implementation of the BioFire BCID panels at the King Abdulaziz University Hospital in Saudi Arabia
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:
Please consult your local bioMérieux representative for product availability in your country
COMPLETE YOUR SOLUTION
ETEST® Ceftazidime/Avibactam (CZA 256)
Test strip for MIC determination of ceftazidime/avibactam
NEW test strips provide Minimum Inhibitory Concentration (MIC) level for antimicrobial susceptibility of Gram-negative bacteria such as Enterobacteriaceae and P. aeruginosa. This information helps support appropriate antimicrobial therapy decisions for better patient outcomes and contributes to antimicrobial stewardship.
- Reliably monitor susceptibility to ceftazidime/ avibactam (Avycaz**/ Zavicefta***)
- Antimicrobial susceptibility determination in as little as 16 hours
- Determines exact MIC values
Do you need more information?
Antimicrobial resistance: Why responsible treatment is critical
Antimicrobial resistance is one of today’s top healthcare concerns worldwide. With the development of Multi-drug Resistant Organisms (MDRO), particularly Gram-negative bacteria, even infections that were once easy to treat can be life-threatening1. Antimicrobial stewardship – appropriate selection and use of antimicrobials – helps improve patient outcomes, prevent resistance development and preserve the effectiveness of new antimicrobials like the ceftazidime/avibactam combination drug. In this context, it’s important for clinicians to have clear and reliable information to make the best decisions for antibiotic therapy – before, during and after treatment. A key part of this is accurate and rapid antimicrobial susceptibility testing – for ceftazidime/avibactam, there’s now ETEST® Ceftazidime/Avibactam (CZA 256).
How can ETEST® CZA 256 strips help?
ETEST® Ceftazidime/Avibactam (CZA 256) strips determine exact Minimum Inhibitory Concentration (MIC) values to assess susceptibility to ceftazidime/avibactam, a new treatment developed to treat some serious infections for which few effective therapies exist1,2,3. Known by the trade name Avycaz** in the U.S. and Zavicefta*** elsewhere, ceftazidime/avibactam acts on Gram-negative bacteria and is indicated for complicated intra-abdominal infections (cIAI) in combination with metronidazole, as well as for the treatment of complicated urinary tract infections (cUTI), including acute pyelonephritis (AP), in patients over 18. Zavicefta is also approved for hospital-acquired pneumonia including ventilator associated pneumonia outside of the United States.
Exact MICs: Real precision in ETEST® CZA 256
Thanks to the determination of exact MIC values, ETEST® CZA 256 strips offer greater precision than conventional two-fold dilutions (i.e. half dilutions) with interpretive category (S, I, R). In as little as 16 hours incubation, you can determine how susceptible the organism is, not just if it is susceptible. This information helps clinicians make informed patient-care decisions for ceftazidime/avibactam therapy and reduce the risk of development of drug-resistant bacteria. Epidemiological tracking of evolution of infectious organisms is also possible with MIC values, helping detect emergence of resistance over time.
ETEST®: Easy, effective and precise
The new ETEST® CZA 256 strips are the latest addition to the ETEST® range – the original gradient strips – which are widely documented for their effectiveness and precision.
Comprised of a MIC reading scale and an antibiotic gradient, ETEST® strips are processed in a similar manner to diffusion methods. They differ in that the antimicrobial concentration gradient is preformed, predefined and stable, and not dependent on diffusion. On an inoculated agar surface, the antibiotic gradient forms a stable, continuous and exponential gradient of antibiotic concentration. Bacteria grow under the strip, forming an ellipse on the scale, on which you can read the MIC value. Over 90 antimicrobial references are available in the ETEST® range, for easy, effective and precise testing for antibiotics and antifungals, as well as for antimicrobial resistance detection (ARD).
Sources:
1. Mosley, J.F. et. al. Ceftazidime-Avibactam (Avycaz) For the Treatment of Complicated Intra-Abdominal and Urinary Tract Infections. Pharmacy & Therapeutics. 41(8): 479–483. 2016 Aug.
2. Nicolau, D.P. Focus on ceftazidime-avibactam for optimizing outcomes in complicated intra-abdominal and urinary tract infections. Expert Opin Investig Drugs. 2015;24(9):1261-73.. Epub 2015 Jul 6.
3. Carmeli, Y. Ceftazidime-avibactam or best available therapy in patients with ceftazidime-resistant Enterobacteriaceae and Pseudomonas aeruginosa complicated urinary tract infections or complicated intra-abdominal infections (REPRISE): a randomised, pathogen-directed, phase 3 study. Lancet Infect Dis. 2016 Jun; Epub 2016 Apr 20.
*CE-IVD marked; FDA pending
**Allergan
***Astra Zeneca/Pfizer
ETEST® Ceftazidime/Avibactam (CZA 256)
CONTENT OF THE KIT
Single Pack: 30 test strips
Each strip contains:
- Ceftazidime MIC range: 0.016 - 256 μg/mL
- Avibactam: 4 μg/mL
- 1 Package Insert downloadable from www.biomerieux.com/techlib
- 1 global ETEST® Reading Guide downloadable from www.biomerieux.com/techlib
MATERIALS REQUIRED BUT NOT PROVIDED
Material
- General microbiology laboratory equipment
- Sterile saline (0.85% NaCl)
- Rota-plater: Retro C80 (Ref. 559803)
- Manual applicator or vaccum pen: Mini Grip-It (Ref. 411200), forceps or Nema C88 (Ref. 559804)
- 0.5 McFarland turbidity standard (Ref. 70 900)
- Incubator (35 ± 2 °C)
- Quality control organisms
- Storage containers with active desiccant capsules (Ref. 501603, 559900, 559901 or 559902), or pouches and/or sealing clamps (Ref. 559809)
Recommended Culture Media
Use well-defined and high-quality Mueller Hinton medium that supports good growth. The brand chosen should have good batch-to-batch reproducibility to ensure that accurate and reliable MIC values are obtained.
To check the quality of media, test appropriate quality control strains. Please refer to the Package Insert provided by the media manufacturer.
Ensure that the agar plate has a depth of 4.0 ± 0.5 mm and pH 7.3 ± 0.1.
WARNINGS AND PRECAUTIONS
- For in vitro diagnostic use only.
- For professional use only.
- Use aseptic procedures at all times when handling bacterial specimens and established precautions against microbiological hazards strictly adhered to.
- Sterilize agar plates after use, before discarding.
- The test device is a disposable; it should not be reused.
Please consult your local bioMérieux representative for product availability in your country
COMPLETE YOUR SOLUTION
BIOFIRE® FILMARRAY® TORCH SYSTEM
BIOFIRE FILMARRAY TORCH Multiplex Real-Time PCR System
The BIOFIRE® FILMARRAY® TORCH system is 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 45 mins to about an hour depending on the panel
- Comprehensive: Tests for a variety of pathogens that cause viral respiratory, pneumonia, bloodstream, gastrointestinal infections, meningitis-encephalitis and joint infections as well antimicrobial resistance genes.
Do you need more information?
Comprehensive syndromic offer for key healthcare challenges
The BIOFIRE® FILMARRAY® TORCH system is an FDA, CE-IVD, and TGA certified multiplex PCR system that integrates sample preparation, amplification, detection and analysis. This simple system requires just 2 minutes of hands-on time, with a total run time of about an hour – you get fast results to assist in better patient care.
The BIOFIRE® FILMARRAY® TORCH system enables simultaneous testing for bacteria, viruses, yeast, parasites and/or antimicrobial resistant genes. It is designed to be used with comprehensive panels that each offer testing for sets of pathogens associated with some of today’s most pressing healthcare challenges.
- BIOFIRE® FILMARRAY® Respiratory Panels: tests for a comprehensive panel of 23 respiratory viruses and bacteria.
- BIOFIRE® FILMARRAY® Blood Culture Identification Panel version 2: tests for a comprehensive list of 33 pathogens and 3 antibiotic resistance genes associated with bloodstream infections.
- BIOFIRE® FILMARRAY® Gastrointestinal Panel: tests for 22 common gastrointestinal pathogens including viruses, bacteria and protozoa that cause infectious diarrhea.
- BIOFIRE® FILMARRAY® Meningitis Encephalitis Panel: tests directly in Cerebral Spinal Fluid for the 14 most relevant ME-associated pathogens, including bacteria, viruses and a parasite.
- BIOFIRE® FILMARRAY® Pneumonia plus Panel: tests for 18 bacteria (11 Gram negative, 4 Gram positive and 3 atypical), 7 antibiotic resistance markers, and 9 viruses that cause pneumonia and other lower respiratory tract infections.
- BIOFIRE® Joint Infection Panel : tests for 28 bacteria (15 Gram positive, 13 Gram negative), 2 yeasts, and 8 antimicrobial resistance genes that cause joint infections.
Fast, accurate molecular diagnostics testing for syndromic diagnosis
BIOFIRE® FILMARRAY® TORCH performs the extraction, amplification and detection in a closed system, minimizing contamination. It is a syndromic testing system for a variety of pathogens associated with key healthcare concerns. The rapid results offer the information needed to help primary care providers and emergency room physicians to better triage patients and make timely, confident medical decisions.
Easy, intuitive operation
The BIOFIRE® FILMARRAY® TORCH multiplex PCR system makes it easy to provide fast, comprehensive and accurate diagnostic results.
- Insert the BIOFIRE® FILMARRAY® pouch into the loading station, and inject the hydration solution along with a sample
- The vacuum in the pouch ensures that the correct volume of hydration solution and sample is drawn into the pouch, so you don’t have to worry about pipetting
- Insert the pouch into the BIOFIRE® FILMARRAY® TORCH system and start your run
- Run time is approximately 1 hour
- Obtain results in easy-to-read reports
The BIOFIRE® FILMARRAY® self-contained pouch
![]() Click to enlarge » |
The BIOFIRE® FILMARRAY® pouch stores all the necessary reagents for cell lysis, DNA/RNA extraction and purification, amplification, and detection in one closed disposable pouch.
- BIOFIRE® FILMARRAY® extracts and purifies all nucleic acids from the unprocessed sample and performs a nested multiplex PCR
- During PCR I, the system performs a single, large volume, multiplexed reaction
- Individual, singleplex PCR II reactions detect the products from the first-stage PCR.
The BIOFIRE® FILMARRAY® software
The BIOFIRE® FILMARRAY® software walks you through the entire process - from sample to result.
Discover the power of your data with BIOFIRE® FIREWORKS™.
A centralized data management portal to better optimize your lab services by taking care of your systems, deliverring insights and analytics into performance and utilization,
pathogens surveillance, lab workflow management and more
BIOFIRE® FILMARRAY® TORCH System Specifications
System Specifications |
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Reagents
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(BIOFIRE® FILMARRAY® TORCH System) Instrument Specifications
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Performance Parameters
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Environmental Specification
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- Healthcare Information
- Our Solutions
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Technical Notes:
Operator's Manual, Instructions for Use, quick guides, Safety Data Sheet are available from our E-Labeling Services website.
The other documents like Product Support Documents and Technical Notes are available on BioFireDx.com Website.
Please consult your local bioMérieux representative for product availability in your country
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