New Opportunities for Microbiology Labs to Add Value to Antimicrobial Stewardship Programs

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1 New Opportunities for Microbiology Labs to Add Value to Antimicrobial Stewardship Programs Patrick R. Murray, PhD Senior Director, WW Scientific Affairs 2017 BD. BD, the BD Logo and all other trademarks are property of Becton, Dickinson and Company.

2 Introduction Microbiologists and physicians were asked in a recent survey to name the most significant changes in microbiology in the last 10 years. The most common answers were: Evolution and global spread of multidrug-resistant bacteria, mycobacteria, and fungi Rapid adoption of molecular tests in infectious disease diagnostics Use of MALDI mass spectrometry for identification of bacteria, mycobacteria, yeasts, and molds Introduction of whole lab automation in clinical microbiology Rapid development of the field of the human microbiome For the purposes of this discussion, we will not address the topic of the human microbiome although it is likely to impact future diagnostics and therapeutics. 2

3 Antimicrobial Resistance (AMR) Deaths attributable to AMR every year Compared to other major causes of death Deaths due to AMR will be disproportionately weighted towards Developing countries due to healthcare infrastructure and resource availability Global deaths due to AMR are projected to rise from 700,000 to 10,000,000 per year by 2050 if immediate action is not taken 3

4 Antimicrobial Resistance In 2013, the CDC published a list of 18 drug-resistant threats in the US. Urgent threat Carbapenem-resistant Enterobacteriaceae (CRE) Serious threat Multidrug-resistant Acinetobacter baumannii (MDR) Multidrug-resistant Pseudomonas aeruginosa (MDR) ESBL-producing Enterobacteriaceae (ESBL) Methicillin-resistant Staphylococcus aureus (MRSA) Vancomycin-resistant Enterococcus (VRE) In February 2017 WHO announced a list of 12 antibiotic-resistant priority pathogens : Critical threats Acinetobacter baumannii: carbapenem-resistant (CRAB) Pseudomonas aeruginosa: carbapenem-resistant Enterobacteriaceae: carbapenem-resistant, ESBL 4

5 Antibiotic Resistance 5

6 Global Prevalence ESBL CTX-M Strains Resistant to all penicillins and cephalosporins 6

7 Carbapenem Resistance KPC NDM OXA VIM 7 Resistant to all beta-lactam antibiotics (penicillins, cephalosporins, carbapenems)

8 Dates of Antibiotic Discovery: 30 Years with No New Classes of Antibacterials 8

9 Future of Diagnostic Microbiology 9

10 10

11 MALDI-TOF Mass Spectrometry BD Bruker Biotyper Vitek MS m/z 11

12 MALDI: Workflow Impact MALDI is less expensive - replaces all identification tests with decreased consumable supplies, QC tests, repeat testing and supplemental tests MALDI is more accurate - analytical sensitivity equivalent to sequencing 100s of genes so accuracy nearly 100% MALDI improves workflow - anaerobes identified as easily as aerobic bacteria with no special procedures such as subcultures, spot biochemical tests, chromatography MALDI is rapid - definitive identification of yeasts, molds and mycobacteria the same day growth is detected MALDI offers clinical value - blood culture isolates identified within 1 hour of detection 12

13 Molecular Carbapenemase Assays for Screening for Carriers Check-Direct CPE assay for BD MAX: KPC 17 variants NDM 10 variants VIM 37 variants OXA 9 variants Cepheid Carba-R for GeneXpert: (number of variants detected not specified) KPC NDM VIM OXA IMP 13

14 Molecular Identification/ Resistance Markers Assay ID Number of Analytes AST >90 meca, vana, vanb 24 meca, vana/b, KPC 22 meca, vana, vanb, IMP, KPC, NDM, OXA, VIM 14

15 Genotypic Tests Phenotypic Tests Genotypic Tests Predicts what Antibiotics Can t Be Used (Resistance) Phenotypic Tests Predicts which Antibiotics Can Be Used (Susceptibility) Molecular Diagnostics (Rule Out) HOSPITAL FORMULARY Antibiotic 1 Antibiotic 2 Antibiotic 3 Antibiotic 4 Antibiotic 5 Antibiotic 6 Antibiotic 7 Phenotypic Susceptibility Tests (Rule In) 15

16 Phenotypic Antimicrobial Susceptibility Tests BD Phoenix bmx Vitek 2 Beckman Coulter MicroScan 16

17 Total Lab Automation 17

18 The Future is Defined by Innovative Thinking Why would you want to automate historical inefficiencies? Think of lab automation as not automating what we do today but allowing us to do things we cannot do today!! Lab automation requires a cultural change for the benefits to be realized. Think Differently! 18

19 Optimized Image Acquisition Poor SNR Optimized SNR 19

20 Microbiology Laboratory A change is needed if microbiology is going to be clinically relevant for patient care: we need to be patient focused!! 20

21 21 Thank you!

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