Rapid diagnostic methods and surveillance

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2 Rapid diagnostic methods and surveillance are some of the most valuable tools in preventing the spread of resistance 1 Rapid diagnostic tests can determine the causative agent and its antibiotic susceptibility. Combined with real-time surveillance tools, they contribute to: inform better decision making with respect to antibiotic use slow the selection of resistant strains in clinical settings enable better disease management and surveillance 1 A Global Challenge The threat of antimicrobial resistance is growing on all fronts: Resistance is now exploding in developing countries, linked to antibiotic misuse, including lack of patient adherence to prescribed treatment, t, over-the-counter antibiotics and counterfeit products. 1 Recently, pan-resistant bacteria have emerged (including Mycobacterium tuberculosis, Klebsiella, and Acinetobacter), which can overcome virtually any antibiotic used. 1 Non-therapeutic use of antimicrobials to promote growth in food-producing animals contributes to the development of resistance, with the risk of transmission of resistant strains to humans via the food chain. 2 There are few antibiotics in the development pipeline to meet the challenge of multi-drug resistance, and the most prudent use of existing antibiotics is crucial to preserve their effi cacy. 1,3 Reducing the emergence and spread of antimicrobial resistance is a global challenge requiring strong and smart actions. Whether healthcare providers, physicians, microbiologists or patients, we are all concerned. Our Personal Commitment Antimicrobial resistance is a serious problem. As healthcare professionals, you need effective tools and actionable results to face the resistance challenge every day. As a market leader in microbiology and a pioneer in resistance detection and susceptibility testing, biomérieux works closely with its healthcare partners to give you the solutions you need to identify, screen, track and prevent resistance. Together, we can take on the challenges of managing antimicrobial resistance more efficiently. To find out more about how our s.m.a.r.t. solutions can benefit your laboratory or hospital, visit : 1 Antibiotic Resistance: An Ecological Perspective on an Old Problem. A Report from the American Academy of Microbiology APUA FAAIR Report. The Need to Improve Antimicrobial Use in Agriculture: Ecological and Human Health Consequences. Clin Infec Dis. 2002; 34(S3):1425-e63 3 ECDC/EMEA Joint Technical Report. The bacterial challenge: time to react EMEA/576176/2009 biomérieux. s.m.a.r.t. Solutions to Manage the Antimicrobial Resistance Threat

3 235 million doses of antibiotics consumed annually in the United States % of that use is unnecessary. 1 In some countries, over 60% of Staphylococcus aureus cases in hospital ICUs are now resistant to first-line antibiotics, including methicillin, oxacillin, penicillin and amoxicillin. 2 A recent study calculated annual costs of antibiotic-resistant infections to the U.S. healthcare system to be in excess of $20 billion. 3 1 Centers for Disease Control and Prevention, Laxminarayan R, et al.. Extending the Cure: Policy responses to the growing threat of antibiotic resistance. Washington, DC, Resources for the Future Roberts RR, et al. Hospital and societal costs of antimicrobial-resistant infections in a Chicago teaching hospital: implications for antibiotic stewardship. Clin Infect Dis ; 49(8) : ECDC/EMEA Joint Technical Report. The bacterial challenge: time to react EMEA/576176/ European Commission: Communication from the Commission to the European Parliament and the Council: Action Plan against the rising threats from Antimicrobial Resistance. COM (2011) Klevens RM. et al. Invasive Methicillin-resistant Staphyloccus aureus infection in the United States. JAMA 2007; 298: The evolving threat of antimicrobial resistance: options for action. World Health Organisation A public health action plan to combat antimicrobial resistance. Part 1: Domestic Issues. Interagency Task Force on Antimicrobial Resistance (ITFAR) How big is the challenge? Antimicrobial resistance is a major public health issue worldwide. Although the natural selection of bacteria makes some resistance inevitable, the problem is largely driven by misuse and overuse of antibiotics. An increasing number of bacteria are becoming resistant to many of the wonder drugs developed to treat the infections they cause. The emergence and spread of multi-drug resistant organisms (MDROs), including methicillin-resistant Staphylococcus aureus (MRSA) and carbapenemases, in particular Klebsiella pneumoniae carbapenemase (KPC), is facilitated by: increasing cross-continental travel and global trade the rising number of healthcare-associated infections over-prescription of broad-spectrum antibiotics. Today, in the European Union, an estimated 4 million patients acquire a healthcare-associated infection, and at least 25,000 people die each year from infections due to just fi ve antibiotic-resistant organisms. 4,5 The economic impact is estimated at 1.5 billion per year. 4 In addition, infections caused by these antibioticresistant bacteria result in approximately 2.5 million extra hospital days annually in Europe. 4 And in the United States, MRSA infections alone kill nearly 19,000 people a year and account for over 60% of the total number of hospital-onset S. aureus infections. 6 As the gap widens between the rising number of MDRO infections and the development of new antibiotics to treat them, Superbugs have become one of healthcare s biggest threats. What actions are being taken? Today, more than ever, a holistic approach to the challenge of antimicrobial resistance is needed, with concerted efforts from human medicine, veterinary medicine, animal husbandry, agriculture and the environment. 7,8 Many initiatives and programs have already been implemented at national and international levels to address this need, including: infection control policies, including hand hygiene / environmental hygiene programs national networks to reinforce surveillance of antibiotic consumption and antimicrobial resistance in human and veterinary medicine antibiotic stewardship committees and guidelines major public awareness campaigns. Such actions have already proved to be effective in reducing the use of antibiotics and the transmission of resistance. Why are diagnostic tests important? Diagnostic tests play an essential role in the diagnosis and monitoring of infection, as well as the surveillance of resistance, and contribute to the prudent use of antibiotics. biomérieux offers a complete range of solutions that spans the full spectrum of in vitro diagnostic technologies, from culture media to molecular biology. biomérieux s portfolio of s.m.a.r.t. solutions contributes to the management of antimicrobial resistance by providing timely actionable results for informed clinical decisions.

4 IDENTIFYING for antimicrobial susceptibility testing Detection of resistance using reliable, proven tools is key to providing the right information for the right antibiotic treatment. VITEK 2 and VITEK MS - The most complete ID/AST solution VITEK 2 Systems and VITEK MS together offer an accurate, fast and innovative solution for identification (ID) and antimicrobial susceptibility testing (AST). Rapid reporting of AST results allows earlier adjustment of antibiotic therapy, resulting in improved clinical and fi nancial outcomes. 1 Low levels of resistance are often overlooked, but can play an important role in the expansion of resistance. 2 1 Barenfanger J, et al. Clinical and Financial Benefi ts of Rapid Bacterial Identifi cation and Antimicrobial Susceptibility Testing. J Clin Microbiol. 1999; 37: Antibiotic Resistance: An Ecological Perspective on an Old Problem. A Report from the American Academy of Microbiology VITEK MS Mass spectrometry system for rapid ID VITEK MS identifi es microorganisms in minutes instead of hours, using cutting-edge mass spectrometry technology. Fully integrated with the AST result from VITEK 2 Systems through the innovative middleware solution, Myla. Etest Agar gradient method: provides MIC * results for slow-growing and fastidious organisms, offers fl exibility in testing new antimicrobials, confi rms specific resistance phenotypes (e.g. ESBL **, MBL 1***, ampc 2 ) helps defi ne optimal antibiotic selection and dosing regimen by combining knowledge of PK/ PD **** parameters with accurate MICs particularly relevant for critical patients. * MIC: Minimum Inhibitory Concentration (lowest concentration of an antimicrobial required to prevent growth of a microorganism) ** ESBL: Extended-spectrum beta-lactamases *** MBL: Metallo-beta-lactamases ****PK/PD: Pharmacokinetic/Pharmacodynamic 1 Etest MBL IP/IPI and MBL MP/MPI are Research Use Only (RUO) products in USA 2 Etest AmpC is a Research Use Only (RUO) product VITEK 2 Systems Automated ID/AST systems Recognized as the world s leading ID/AST platforms, VITEK 2 Systems offer reliable, clinically relevant results with reduced response times. Advanced Expert System (AES) Part of the VITEK 2 Systems, AES software interprets susceptibility test results, and detects complex and constantly evolving resistance, including low-level and unusual resistance profiles. Rapid AST results allow earlier use of narrow-spectrum antibiotics to: reduce antibiotic selection pressure limit development of resistance enhance therapeutic effi cacy for improved patient outcomes.

5 SCREENING for screening and active surveillance Screening patients, as part of an Infection Control program, is an effective measure to contain the spread of multi-drug resistant organisms (MDROs). NucliSENS EasyQ MRSA and chromid MRSA A new efficient and flexible MRSA * screening offer to actively reinforce MRSA surveillance Infection control measures, including active surveillance with screening, reduce the MRSA infection rate by 50%. 1 Frequency of MRSA transmission is reduced 38-fold if patients are identifi ed and isolated. 2 NucliSENS EasyQ MRSA Molecular assay for MRSA screening Real-time amplifi cation and detection in less than 3 hours enables rapid patient isolation to help prevent further transmission. More MDRO Screening Solutions chromid ESBL / chromid VRE / chromid CARBA Simple-to-use and extremely easy-to-read, the chromid range of chromogenic media also enables identification of ESBL ** and carbapenemases, as well as VRE ***. chromid MRSA Chromogenic medium Combines S. aureus identification with direct detection of resistance mechanisms. Provides colony isolation and identification of MRSA in hours. Whatever your screening needs, we offer an appropriate RELIABLE solution for: emergency or routine testing with maximum fl exibility (24/7) all patient situations (at-risk, pre-operative, systematic...) 1 Clancy M, et al. Active screening in high-risk units is an effective and cost-avoidant method to reduce the rate of methicillin-resistant Staphylococcus aureus infection in the hospital. Infect Control Hosp Epidemiol. 2006; 27: Vriens MR, et al. Is methicillin-resistant Staphylococcus aureus more contagious than methicillin-susceptible S. aureus in a surgical intensive care unit? Infect Control Hosp Epidemiol 2002; 23: Diagnosis and surveillance of Clostridium difficile infections are essential for rapid patient isolation to contain further spread. VIDAS GDH C. difficile 1 Automated solution for Glutamate-dehydrogenase (GDH) detection in less than 50 minutes. Sensitive, fi rst-line test for screening patients with clinically suspected C. diffi cile infection. VIDAS C. difficile Toxin A & B Automated solution for C. diffi cile toxin detection in 75 minutes. High specificity for earlier decisions on isolation/containment procedures. * MRSA: Methicillin-resistant Staphylococcus aureus - **ESBL: Extended-spectrum beta-lactamase - ***VRE: Vancomycin-resistant enterococci 1. Under development

6 TRACKING for outbreak management / trend monitoring Effective tracking of microbial infections and resistance patterns is important to implement relevant infection control and antibiotic policies. Reporting of antimicrobial resistance data is necessary for selection of empirical therapy at local level, [...] for monitoring changes in resistance rates, and for detecting the emergence and spread of new resistance types. 1 NucliSENS EasyQ KPC (RUO) * Detection and confirmation of resistance mechanisms one test to detect all KPC ** variants (KPC-2 to KPC-13) results in less than 4 hours on colonies and rectal swabs fully standardized test can be performed on SmartCycler and ABI VIGIguard *** Epidemiology software for 24/7 surveillance of microbial resistance patterns: receives ID/AST **** results directly from VITEK 2 system provides local epidemiological data to adjust fi rst-line antibiotic treatment gives continuous alerts in real-time to rapidly initiate isolation of MDRO carriers helps assess the effi cacy of Infection Control protocols to evaluate the impact of preventive and corrective actions. Same-day confirmation of resistance mechanisms and genotyping results help institutions to: conduct point prevalence studies react quickly to contain outbreaks control the spread of infection DiversiLab Automated strain typing platform same-day, standardized, reproducible results rapid identification and genotypic characterization of causative organism and source of possible outbreaks fast tracking of the spread of bacterial infections Epidemiology software is essential to: maintain real-time surveillance detect and monitor resistance trends adjust empiric antibiotic therapies 1 Cornaglia G. et al. European recommendations for antimicrobial resistance surveillance. ESCMID Study Group Report. Clin Microbiol Infect. 2004; 10: * for Research Use Only - **KPC: Klebsiella pneumoniae carbapenemase - ***not available in US - ****ID/AST: Identifi cation / Antimicrobial Susceptibility Testing

7 PREVENTING for appropriate prescribing of antibiotics Bacterial or viral? Fast identifi cation of patients requiring antibiotics helps reduce inappropriate use of available antimicrobial therapies. As much as 75% of antibiotics are prescribed for acute respiratory tract infections (ARTI), despite the mainly viral origin. 1 Of 41 million antibiotic prescriptions for respiratory infections in the U.S., 22.5 million (55%) were estimated to have been prescribed for infections unlikely to have a bacterial etiology. 2 1 Macfarlane J, et al. Contemporary use of antibiotics in 1089 adults presenting with acute lover respiratory tract illness in general practice in the U.K. Respir Med. 1997; 91: Gonzales R, et al. Excessive antibiotic use for acute respiratory infections in the United States. Clin Infect Dis 2001; 33: Briel M, et al. Procalcitonin-guided antibiotic use versus a standard approach for acute respiratory tract infections in primary care. Arch Intern Med 2008; 168: Schuetz P, et al. Effect of Procalcitonin-Based Guidelines vs Standard Guidelines on Antibiotic Use in Lower Respiratory Tract Infections : The ProHOSP Randomized Controlled Trial JAMA 2009; 302: Christ-Crain M, et al. Procalcitonin guidance of antibiotic therapy in community-acquired pneumonia. Am J Respir Crit Care Med. 2006; 174: Nobre V, et al. Use of procalcitonin to shorten antibiotic treatment duration in septic patients. Am J Respir Crit Care Med. 2007; 177: Bouadma L, et al. Use of procalcitonin to reduce patients exposure to antibiotics in intensive care units (PRORATA trial): a multicenter randomized controlled trial. Lancet. 2010;375: Schuetz P. et al. Procalcitonin algorithms for antibiotic therapy decisions: a systematic review of randomized controlled trials and recommendations for clinical algorithms. Arch Intern Med. 2011;171: Poehling KA, et al. Accuracy and impact of a point-of-care rapid infl uenza test in young children with respiratory illnesses. Arch Pediatr Adolesc Med. 2006; 160: Bonner AB, et al. Impact of the rapid diagnosis of infl uenza on physician decision-making and patient management in the pediatric emergency department : Results of a randomized, prospective, controlled trial. Pediatrics. 2003; 112: VIDAS B. R. A. H. M. S PCT Rapid procalcitonin assay Procalcitonin (PCT) is a specifi c blood biomarker supporting improved management of patients with severe bacterial infections and sepsis: diagnosis of severe bacterial infections differentiation of bacterial from viral diseases and other medical conditions prognosis of the severity of a patient s condition guidance on clinical decisions regarding initiation and earlier discontinuation of antibiotic therapy. bionexia Influenza A + B and CRPplus Rapid easy-to-use tests ideal for first-line testing provide rapid results in 5 to 10 minutes for the detection of ARTI ** and infl ammatory conditions. * LRTI: Lower Respiratory Tract Infection - ** ARTI: Acute Respiratory Tract Infection PCT-based decision algorithms support antibiotic stewardship and help control antimicrobial resistance by: reducing the use of antibiotics in LRTI * in Emergency settings. 3,4 guiding the duration of antibiotic therapy in critically ill patients with sepsis or acute LRTI, reducing the number of treatment days without compromising patient outcome 3,4,5,6,7,8 Use of rapid tests in ARTI helps clinicians: prescribe antibiotics only when necessary reduce the need for additional testing and associated costs 2 decrease length of stay in the emergency department 9, 10

8 EDUCATION on for educational initiatives an essential part of meeting the resistance challenge Raising public awareness and mobilizing major stake-holders through nationwide campaigns, annual events and international agreements is key to achieving more prudent use of antibiotics and reducing levels of antimicrobial resistance. Examples of national and international actions SUCCESSFUL CAMPAIGNS Antibiotics are not Automatic Anymore In a country previously known for the highest rates of antibiotic use in Europe, two national campaigns in France ( and ) led to a marked reduction in the overall consumption of antibiotics by 15-20% in the community and 10-15% in hospitals. A third campaign ( ) is currently in place with the objective of reducing antibiotic consumption by around 25% over the 5-year period. 1 Save antibiotics, they may save your life Yearly mass media campaigns in Belgium since 2000 have been associated with a 34% reduction in antibiotic use in the community. These campaigns have resulted in huge cost savings of about 250 million since 2000 and for every Euro invested, about 8 have been saved. 2 Fewer antibiotics prescribed for children In the US, the number of pediatric antibiotic prescriptions decreased by 14% from 2002 to 2010 following major efforts to educate parents about the futility of treating viral infections with antibiotics and about the concerns of antibiotic resistance. 3 INTERNATIONAL INITIATIVES Transatlantic Task Force on Global Antibiotic Resistance (TATFAR) The United States and EU countries have joined forces to combat the global health issue of antibiotic resistance, which threatens patient safety and public health worldwide. This international agreement seeks cooperative ways to address antimicrobial resistance and encourage global research and development of antibiotics. 4 ANNUAL EVENTS European Antibiotic Awareness Day Initiated by the European Centre for Disease Prevention and Control (ECDC) to raise awareness among the general public and primary care providers of the threat of antibiotic resistance to public health and how to use antibiotics responsibly. Get Smart about Antibiotics Week A US-wide event initiated by the Centers for Disease Control and Prevention (CDC). Targeting patients and providers, it focuses on antibiotic resistance and the importance of appropriate antibiotic use. 1 Plan national d alerte sur les antibiotiques (National Alert Plan on Antibiotics). Document issued by the French Ministry of Health. 2 Goosens H, et al. Achievements of the Belgian Antibiotic Policy Coordination Committee (BAPCOC) Poster presented at 3rd World HAI Forum. Annecy Chai G, et al. Trends of Outpatient Prescription Drug Utilization in US Children, Pediatrics. Published online June 18, doi: /peds Recommendations for future collaboration between the U.S. and EU. Transatlantic Taskforce on Antimicrobial Resistance biomérieux actively organizes or sponsors high-level scientifi c events, publications and initiatives to further information exchange and education in the fi eld of antimicrobial resistance. biomérieux - initiated actions Research awards for work by young scientists in the fi elds of Clinical Microbiology (ESCMID/bioMérieux Research Grant / biomérieux Sonnenwirth Award) and Food Science (Larry Beuchat Young Researcher Award). Educational handbooks and booklets newsletter provides state-of-the-art news from leading microbial resistance experts. website for the latest updates on diagnostic tools and solutions to help manage the antimicrobial resistance threat. Educational partnerships with leading academic and professional associations, e.g., French National Observatory for Epidemiology of Bacterial Resistance to Antimicrobials (ONERBA). World Forum on Healthcare Associated Infection This unique bi-annual event hosted by biomérieux gathers together over 50 world-renowned experts in HAI and antimicrobial resistance. The 3rd HAI Forum held in 2011 resulted in the publication of a Global Call to Action on Antimicrobial Resistance, featured in the journal Antimicrobial Resistance and Infection Control 5 biomérieux Symposia / Customer Workshops on antimicrobial resistance held in Belgium, Germany, Indonesia, Korea, Japan, Spain, Vietnam, the United Kingdom and the United States.

9 09-12 / /002/GB/B / Document and/or pictures not legally binding / Modifi cations by biomérieux can be made without notice / BIOMERIEUX, the blue logo, bionexia, chromid, DiversiLab, Etest, Myla, NucliSENS EasyQ, VIDAS, VIGIguard, VITEK and BE S.M.A.R.T. WITH are used, pending and/or registered trademarks belonging to biomérieux, or one of its subsidiaries, or one of its companies /B.R.A.H.M.S PCT is the property of Thermo Fisher Scientifi c Inc. and its subsidiaries / Any other name or trademark is the property of its respective owner. / biomérieux RCS Lyon / Photos: biomérieux, Getty Images, N. Bouchut / Printed in France / THERA Conseil / RCS Lyon B biomérieux S.A Marcy l Etoile France Tel.: +33 (0) Fax: +33 (0) SELECTED RESOURCES ON ANTIMICROBIAL CDC: Centers for Disease Prevention and Control (National Antimicrobial Resistance Monitoring System: enteric bacteria) EARS-Net: European Antimicrobial Resistance Surveillance Network ECDC: European Center for Disease Prevention and Control ESAC-Net: European Surveillance of Antibiotic Consumption Network FDA: US Food and Drug Administration WHO: World Health Organisation