ETEST^® Meropenem Vaborbactam (MEV)* strips are your new rapid, reliable solution for meropenem and vaborbactam susceptibility testing.

Optimizing antibiotic therapy in the face of growing resistance threat

Multi-drug Resistant Organisms (MDRO), particularly in Gram-negative bacteria, is a serious and growing healthcare threat. Ensuring that patients get the right antimicrobial, in the right dose, at the right time is at the heart of antimicrobial stewardship. This helps improve patient outcomes, prevent the development of resistance and preserve the effectiveness of new therapeutic molecules. Vigilant and accurate antimicrobial susceptibility testing is a critical part of fighting resistance.

ETEST^® MEV strips offer an easy and reliable method to determine, with exact MIC values, infectious organisms’ susceptibility to meropenem and vaborbactam, to help ensure optimal treatment and follow-up with these antibiotics.

When therapy options are limited, clinicians may turn to a new-generation antibiotic based on an association of meropenem and vaborbactam, which is marketed as VABOMERE^® in the US and as VABOREM internationally. It is indicated for the treatment of patients 18 years of age and older with complicated urinary tract infections (cUTI) including pyelonephritis. Outside the United States it may also be used for complicated intra-abdominal infections and hospital-acquired pneumonia (HAP), including ventilator-associated pneumonia (VAP).

Exact MIC with ETEST^® MEV

ETEST^® MEV strips are easy-to-use but they provide a wealth of information. ETEST^® generates Minimum Inhibitory Concentration (MIC) values from a continuous scale and can give results in between conventional two-fold dilutions, i.e. half dilutions. This means that, unlike diffusion methods, they can provide the exact MIC breakpoint as well as the interpretive category (S, I, R). Not only do you know if an organism is susceptible, you know with great precision how susceptible – information that can help best adapt antibiotic therapy to fight the infection while reducing the risk of development of drug-resistant bacteria. Having precise MIC values also enables epidemiological tracking of evolution of infectious organisms, to detect emergence of resistance over time.

The thin, inert and non-porous plastic ETEST^® MEV strips have the Minimum Inhibitory Concentration (MIC) reading scale in μg/mL on one side and a predefined antibiotic gradient on the other. After applying a strip to an inoculated agar surface, the antibiotic gradient transfers into the agar and will form a stable, continuous and exponential gradient of antibiotic concentration. Bacteria grow under the strip, forming an ellipse. With as little as 16 hours incubation, you can read the MIC value on the scale, with complete inhibition seen where the pointed end of the ellipse intersects the strip. It’s that simple.

Part of the ETEST^® range

The new ETEST^® MEV strips join the family of ETEST^®, the original gradient strips. ETEST^® strips are widely documented for their effectiveness and precision. With an extensive range of over 95 antimicrobial references available, ETEST^® offers precision in testing the on-scale MIC for antibiotics, antifungals, as well as for antimicrobial resistance detection (ARD).

* CE-IVD marked; FDA cleared

** MELINTA (US)

*** MENARINI (outside the US)

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.

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

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

ETEST^® Ceftolozane/Tazobactam (C/T)* strips are your new rapid, reliable solution for ceftolozane and tazobactam susceptibility testing.

Optimizing antibiotic therapy in the face of growing resistance threat

Multi-drug Resistant Organisms (MDRO), particularly in Gram-negative bacteria, is a serious and growing healthcare threat. Ensuring that patients get the right antimicrobial, in the right dose, at the right time is at the heart of antimicrobial stewardship. This helps improve patient outcomes, prevent the development of resistance and preserve the effectiveness of new therapeutic molecules. Vigilant and accurate antimicrobial susceptibility testing is a critical part of fighting resistance.

ETEST^® C/T strips offer an easy and reliable method to determine, with exact MIC values, infectious organisms’ susceptibility to Ceftolozane and Tazobactam, to help ensure optimal treatment and follow-up with these antibiotics.

Based on a combination of Ceftolozane and Tazobactam, Zerbaxa^® is indicated for the treatment of adult patients with complicated urinary tract infections (cUTI) including acute pyelonephritis, and, in combination with metronidazole, complicated intraabdominal infections (cIAI). Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, and Pseudomonas aeruginosa are among the Gram-negative microorganisms it treats.

Exact MIC with ETEST^® C/T

ETEST^® C/T strips are easy-to-use but they provide a wealth of information. ETEST^® generates Minimum Inhibitory Concentration (MIC) values from a continuous scale and can give results in between conventional two-fold dilutions, i.e. half dilutions. This means that, unlike diffusion methods, they can provide the exact MIC breakpoint as well as the interpretive category (S, I, R). Not only do you know if an organism is susceptible, you know with great precision how susceptible – information that can help best adapt antibiotic therapy to fight the infection while reducing the risk of development of drug-resistant bacteria. Having precise MIC values also enables epidemiological tracking of evolution of infectious organisms, to detect emergence of resistance over time.

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.}

Clear identification of S. aureus

bioMérieux’s CHROMID^® S. aureus Elite agar is an innovative chromogenic medium that offers detection of Staphylococcus aureus in only 18 to 24 hours. With resistant forms of S. aureus on the rise and posing a serious threat to human health¹, quality early tests for these bacteria are important to patient care.

CHROMID^® S. aureus Elite agar is part of the CHROMID^® range, an easy to use, standardized method for the simultaneous culture and identification of microorganisms in clinical specimens. Peptones and a chromogenic substrate in the CHROMID^® S. aureus Elite agar enable the growth and direct identification of S. aureus colonies, which spontaneously turn pink for easy identification. It can be used with numerous different sample types: blood cultures, nasal swabs, suppurations, ear/nose/throat samples, genital samples, stool samples, skin samples from serious burn victims, and respiratory samples (including respiratory samples from patients with cystic fibrosis).

• Sensitivity 90.5% (IC*: [85.6-93.8]) and specificity 97.9% (IC*: [96.1-99.0]) at 18-24 hours, for patients without cystic fibrosis
• Sensitivity 95.4% (IC*: [89.5-97.4]) and specificity 100% (IC*: [92.2-100]) at 72 hours, for respiratory samples from cystic fibrosis patients
• Cost-effective pre-plated media
• Easy-to-use, standardized method

Cystic fibrosis patients

More rapid, accurate detection of S. Aureus in respiratory samples

S. aureus is usually one of the first bacteria to be detected in respiratory samples from cystic fibrosis patients. To improve overall prognosis, it is important to select the most appropriate antibiotic for cystic fibrosis patients with early-stage S. aureus and implement it as early as possible². Persistent colonization with these bacteria leads to progressive pulmonary damage and may help promote the growth of other organisms, such as Pseudomonas aeruginosa. Coculture and coinfection can also promote increased growth and virulence of antibiotic-resistant S. aureus³. After 48-72 hours, CHROMID^® S. aureus Elite offers sensitivity and specificity superior to other methods^4,5, offering confidence in this early test.

^{1.        CDC. Antibiotic Resistance Threats in the United States 2013.}

^{2.        Goss, C. and Muhlebach, M., Staphylococcus aureus and MRSA in cystic fibrosis. Journal of Cystic Fibrosis 10 (2011) 298-306.}

^{3.        Hammer, N.D. et al. - Inter- and Intraspecies Metabolite Exchange Promotes Virulence of Antibiotic-Resistant Staphylococcus aureus. - Cell Host & Microbe 16 , 531–537, October 8, 2014.}

^{4.        V.Tafani  et al, ASM 2016 - Clinical evaluation of a new chromogenic medium for the isolation of staphylococcus aureus in various samples including cystic fibrosis patients}

^{5.        PREECE C., PERRY A., JONES A. L. and al. – Comparison of two chromogenic media for isolation of S. aureus from respiratory samples of patients with cystic Fibrosis – Journal of cystic Fibrosis - 2015 – Vol. 14, Suppl. 1, p. S73.}

Simple, comprehensive meningitis/encephalitis testing

The BIOFIRE^® FILMARRAY^® Meningitis/Encephalitis (ME) Panel tests cerebrospinal fluid (CSF) for the 14 most common pathogens responsible for community acquired meningitis or encephalitis including viruses, bacteria and yeast. The Panel received FDA De Novo clearance in October 2015*. It is designed for use with the integrated BIOFIRE^® FILMARRAY^® system, an FDA, CE-IVD, and TGA certified multiplex PCR system.  With sample preparation, amplification, detection and analysis in one automated system, total run time is about an hour, with only 2 minutes of hands-on time.

Meningitis affects more than 1.2 million people and bacterial meningitis causes 120,000 deaths globally each year ¹. It often affects healthy people, but environmental factors and immunocompromised conditions (due, for example, to HIV or chemotherapy) are significant risks. Meningitis can cause brain damage, hearing loss, blindness and death. Symptoms can appear suddenly and escalate quickly, so rapid diagnosis is critical to patient outcomes.  Yet, due to overlapping symptoms, rapid identification of the causative agents is not possible based on clinical indications alone.^2,3

Now, the unique BIOFIRE^® FILMARRAY^® ME Panel is the first system to be able to simultaneously test for 14 targets on a single CSF sample. This provides accurate identification with a rapid one-hour turnaround, helping clinicians to quickly ensure appropriate care. Testing CSF for multiple organisms has previously been problematic because it may be difficult to obtain enough fluid from the patient to run multiple tests⁴. The BIOFIRE^® FILMARRAY^® ME Panel can contribute to better antimicrobial resistance management by avoiding unnecessary antibiotic use; reducing lengths of hospital stays and decrease costs⁵.

• 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 14 targets

The other availabl e panels are:

• BIOFIRE^® FILMARRAY^® BCID panels
• BIOFIRE^® FILMARRAY^® Respiratory panel
• BIOFIRE^® FILMARRAY^® GI panel
• BIOFIRE® FILMARRAY^® Pneumonia plus Panel

14 target pathogens at once

BIOFIRE^® FILMARRAY^® ME Panel targets:

* FDA allows marketing of the first nucleic acid-based test to detect multiple pathogens from a single sample of cerebrospinal fluid. FDA press release, October 8, 2015; CE-mark pending soon

References:

1) http://www.comomeningitis.org/news-and-events/world-meningitis-day. Accessed April 3, 2015

2) Bamberger DM. Am Fam Physician. 2010;82:1491-1498.

3) NINDS. Meningitis and Encephalitis Fact Sheet. Updated November 24, 2014. Accessed January 6, 2015.

4) FDA allows marketing of the first nucleic acid-based test to detect multiple pathogens from a single sample of cerebrospinal fluid- FDA press release, October 8, 2015

5) K.M. McNabb et al. Implementation of a Rapid Molecular Meningitis Panel. Poster 2017.  New Hanover Regional Medical Center. Wilmington, North Carolina