Sensitivity and ease of use - A global approach to human and animal health - Leading the charge on Multi-Drug Resistant Organisms

Colistin is a polymyxin, with broad-spectrum activity against Gram-negative bacteria. Used in agriculture to control infection in pigs and cattle, it has recently been re-introduced as a last-resort option for humans to treat certain antibiotic-resistant strains. Transferable Colistin resistance, via the plasmid-borne mcr-1 gene, is now emerging in both humans and animals, compromising this antibiotic’s clinical utility^1,2. Its continued spread may lead to the global presence of pan-drug-resistant pathogens^1,2. Efficient Colistin resistance screening can help prevent that spread and preserve polymyxins for future generations. 

Sensitivity and ease of use

CHROMID^® Colistin R is the first validated chromogenic medium to enable the isolation and screening of acquired Colistin-resistant Enterobacteriaceae : E.coli, K.pneumoniae, Salmonella.

It facilitates tracking of Colistin resistance in both asymptomatic carriage and infected patients to ensure earlier appropriate antimicrobial therapy:

• After 4/5 hour enrichment using BHI broth, results in 18/24-hours for timely detection
• Easy to use for clear-cut detection of mixed cultures
• Sensitive method for increased result confidence³
• Validated for use with stools and rectal swabs

Identification is easy to perform: CHROMID^® Colistin R is compatible with VITEK^® 2, VITEK^® MS.

A global approach to human and animal health

Just as micro-organisms know no borders, there are no borders between human and animal health. In line with the FAO-OIE-WHO initiative to coordinate global activities and address health risks at the animal-human-ecosystems interfaces⁴, bioMérieux is developing a “One Health” approach in the development of new products. Mobile Colistin resistance is a huge threat for both human and animal health. That’s why CHROMID^® Colistin R was designed and validated for use on both clinical and veterinary samples.

Leading the charge on Multi-Drug Resistant Organisms

With 50 years of expertise in infectious diseases, bioMérieux is a pioneer in the development of antibiotic resistance detection and susceptibility testing. Fighting antimicrobial resistance is one of our priorities.

CHROMID^® Colistin R is part of our extensive multi-drug-resistant organism screening range, which also includes CHROMID^® MRSA SMART, CHROMID^® VRE, CHROMID^® ESBL, CHROMID^® CARBA SMART, CHROMID^® CARBA and CHROMID^® OXA-48. The CHROMID^® range of culture media helps make it possible to provide targeted, adjusted and specific therapies for improved patient outcome, while preventing the spread of antibiotic resistance worldwide.

References:

1 .   Caniaux I, et al. Eur J Clin Microbiol Infect Dis. 2017 Mar;36(3):415-420.

2.    Liu YY, et al. Lancet Infect Dis, 2016; 16(2):161-8.

3.    Roche JM, et al. Poster presented at ECCMID 2017.

4.    Food and Agriculture Organization (FAO) - World Organisation for Animal Health (OIE) - World Health Organization (WHO). A Tripartite Concept Note. April 2010.

http://www.who.int/influenza/resources/documents/tripartite_concept_note_hanoi_042011_en.pdf

ETEST^® P/T: Support optimized therapy

ETEST^® PIPERACILLIN/TAZOBACTAM (ETEST^® P/T) is a reliable solution for determining MIC of Piperacillin/Tazobactam of Enterobacteriaceae, Pseudomonas aeruginosa and Acinetobacter spp. By determining the exact Minimum Inhibitory Concentration (MIC), you gain more precise susceptibility information to support appropriate prescription and optimized Piperacillin/Tazobactam therapy for challenging situations.

Piperacillin/Tazobactam (Tazocin^® and associated generics) is an association of a Piperacillin (ureidopenicillin) with broad spectrum anti-bacterial activity and Tazobactam (β-lactamase-inhibitor) expanding the antimicrobial spectrum. It is used to treat serious infections caused by Gram-negative bacteria including lower respiratory tract infections, urinary tract infections, intra-abdominal infections, bacterial sepsis and others. 

High performance susceptibility testing

ETEST^® P/T performance characteristics for Piperacillin/Tazobactam have been established using comparative evaluations at external clinical sites. These studies have shown that ETEST^® P/T MICs correlate with the CLSI method when MIC values from both procedures show an essential agreement (EA) of ≥ 90% within ± 1 dilution.

ETEST^®: Developments for new resistance challenges

Fast-rising antimicrobial resistance challenges make appropriate use of antimicrobials critical to help limit the emergence of new resistance and preserve the effectiveness of therapeutic options for challenging situations. ETEST^® PIPERACILLIN/TAZOBACTAM is one of several new and redesigned ETEST^® strips – part of an ongoing commitment to keep up-to-date with evolving microbiology needs. Other recent additions include ETEST^® CEFTOLOZANE/TAZOBACTAM and ETEST^® CEFTAZIDIME/AVIBACTAM.

Leveraging lab expertise: integrated ID/AST

Innovation in microbiology must never stop – because your lab challenges never stop. For more than 50 years, bioMérieux has shared your commitment to continually strengthen laboratory impact on patient therapy.

ETEST^® is part of bioMérieux’s integrated ID/AST* offer. Together with our blood culture offer, these solutions meet your needs from the most routine to the truly challenging. Our offers let you leverage your expertise to deliver test results that enable the healthcare team to provide timely, appropriate therapy.

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 earlier^1,2,3, 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 minutes^1,2,3,4.

• 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 sooner^3,6.

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 steps^7,8
• 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.}

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

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.

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.

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

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 exist^1,2,3. 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

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.

1. Insert the BIOFIRE^® FILMARRAY^® pouch into the loading station, and inject the hydration solution along with a sample
2. 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
3. Insert the pouch into the BIOFIRE^® FILMARRAY^® TORCH system and start your run
4. Run time is approximately 1 hour
5. Obtain results in easy-to-read reports
   
    

Click to enlarge »

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