IAI INTRA-ABDOMINAL INFECTION APPLICATION

Transcription

1 IAI INTRA-ABDOMINAL INFECTION APPLICATION Investigational Use. Not available for Sale in the United States.

2 Content UNYVERO IAI APPLICATION The Unyvero IAI Application is a high-quality tool to detect pathogens (bacteria and fungi), toxins, and antibiotic resistance markers in severe intra-abdominal infections. The Unyvero IAI Cartridge analyzes simultaneously in one patient sample over 100 DNA targets. In a few hours, specific analytes for resistance markers, pathogens, toxins and also a Universal Bacteria primer are assayed. Intra-abdominal infections are associated with unmet medical needs. The Unyvero approach helps to make informed treatment decisions at an earlier stage. Intra-abdominal INFECTIONs Antibiotic Resistances are Increasing UNYVERO IAI Intra-Abdominal infection Application Unyvero System Universal platform 10 COVERAGE DIVERSITY Reliability 11 A comprehensive panel Native sample types Established Technologies in a new Format Unyvero workflow Unyvero System and applications UNYVERO AT A GLANCE Investigational Use. Not available for Sale in the United States. 3

3 Improving treatment of patients with acute abdomen, including peritonitis, acute pancreatitis and megacolon requires rapid pathogen identification. INTRA-ABDOMINAL INFECTION INTRA-ABDOMINAL INFECTION Second Most Common Cause of Mortality From Infections in Intensive Care Intra-abdominal infections (IAI), associated with abdominal cavity exudations, elicit within the peritoneum complex inflammatory responses to microorganisms and their toxins. IAI is the second most common type of infections in patients with severe sepsis and ranks second as cause of death in US intensive care units. In addition, complicated IAIs, with a yearly incidence rate of 300,000 cases in the US, present a significant burden to health care systems. Intra-abdominal infections are classified as: > community-acquired intra-abdominal infection (CA-IAI) > healthcare-acquired intra-abdominal infection (HA-IAI) The acute abdomen, a case of emergency, often caused by severe infections and necessitate timely medical attention. Sources of infections are mostly the appendix, gall bladder, or are associated with colon or gastro-duodenal perforations, or diverticulitis. 4 Investigational Use. Not available for Sale in the United States. 5

4 Antibiotic Resistances are Increasing ANTIBIOTIC RESISTANCE Get the Better of a Serious Problem by Early Identification The medical challenge of today is to treat complex IAI infections that are due to multiple pathogens, together with the significant risk of complications. Therefore, in cases of nosocomial intra-abdominal infections, the first choice of antimicrobial treatment is of major importance. According to various publications, unsuitable antimicrobial therapy seems to be linked to longer inpatient residence and higher fatality rates. An increasing resistance to Gram negative pathogens, which are responsible for serious nosocomial infections, e.g. intra-abdominal infections such as: > ß-lactam resistance Enterobacteriacea > carbapenem resistance Enterobacteriacea > MDR P. aeruginosa is the result of an increasing acquisition of resistance genes worldwide. The global alliance to optimize rational use of antimicrobials for intra-abdominal infections (AGORA) recommended: An optimal antimicrobial approach to treating IAI involves a delicate balance between the optimization of empiric therapy, which improves clinical outcomes, and the reduction of excessive antimicrobial use that increases the rate of emergence of antimicrobial-resistant strains. Early pathogen and antibiotic resistance gene identification with rapid molecular tests may overcome those problems. 6 Investigational Use. Not available for Sale in the United States. 7

5 Unyvero IAI Intra-Abdominal Infection Application PCR set-up SOLUTION UNYVERO IAI APPLICATION DNA purification Multiplex PCR with array detection THE UNIQUE UNYVERO IAI CARTRIDGE COVERS PATHOGENS, ANTIBIOTIC RESISTANCE MARKERS AND TOXINS, AND COMBINES Unique solution tailored to clinical needs > DNA purification > PCR set-up > multiplex endpoint PCR > detection by array hybridization Therefore, the closed Unyvero Cartridge is equipped with integrated reagent containers, a DNA purification column, eight PCR chambers, and an according number of detection arrays. The cartridge is pre-filled with buffers for DNA clean-up, reagents, and fluorescence-labeled primers for PCR amplification, and for array hybridization of the PCR product. > Comprehensive, disease-specific test panels run on an easy to operate platform, requiring neither the special infrastructure of a laboratory environment nor specially trained personnel. > Translates a complex laboratory process into an easy to use format. In addition to the unprocessed patient sample, only enzymes for DNA amplification are required for the analytical process. > Generates complete diagnostic information in 4 5 hours, without any further operator interaction. 1. Unyvero T1/B1 Sample Tube for preparation of the patient sample, pre-filled with specific lysis reagents. 2. Unyvero T1/B1 Sample Tube Cap seals the Unyvero Sample Tube and contains proteinase K and an internal control gene for quality control. 3. Unyvero T1 Sample Pre-Treatment Tool is an aid for preparation and processing of sample materials. 4. Unyvero M1 Master Mix Tube containing reagents for DNA amplification Investigational Use. Not available for Sale in the United States. 9

6 Unyvero System And Applications INTRA-ABDOMINAL INFECTION ASSAY UNYVERO SYSTEM UNIVERSAL PLATFORM FEATURING MANY DIFFERENT APPLICATIONS Unyvero L4 Lysator Unyvero C8 Cockpit Unyvero A50 Analyzer 1. Coverage A selection of pathogens, toxins, and antibiotic resistances based on incidence, clinical importance, and treatment guidlines > OVER 100 targets 2. Diversity Enables testing of clinically relevant sample types of abdominal cavity > Bile, Peritoneal Fluid and Ascites > Tissue > swabs, catheter tips > Positive IAI fluid in Blood Culture Bottle 3. Speed Delivers clinically relevant answers in time 4 5 h Unyvero Application Cartridges PreRequisites GOLDEN HOUR In the face of emerging multiresistant organisms, antimicrobioal selection becomes more and more difficult, because many different genetic mechanisms are involved. Therefore, testing a broad spectrum with over 100 targets is required to get accurate information for guiding adequate, targted therapy. UNYVERO HELPS TO > focus on the appropriate therapy > choose the right antibiotic > improve disease outcome > DETECTION of COMPLICATED INTRA-ABDOMINAL INFECTIONS > Any infection focus > VARIOUS NATIVE SAMPLE TYPES > Over 100 Targets > 1 CARTRIDGE 10 Investigational Use. Not available for Sale in the United States. 11

7 A comprehensive panel Coverage - Antibiotic resistances, Clinically relevant pathogens and Toxins Including Universal Bacteria Primer Group Pathogen Group Pathogen Gene resistance against Toxin marker toxin Gram-positive bacteria Anaerobic / facultative anaerobic bacteria Enterobacteriaceae Universal Bacteria Coagulase negative staphylococci (CNS) 1 Enterococcus faecalis Enterococcus spp. 2 Streptococcus spp. 3 Staphylococcus aureus Aeromonas spp. 4 Bacteroides fragilis group 5 Bacteroides spp. / Prevotella spp. 6 Clostridium difficile Clostridium perfringens Finegoldia magna Propionibacterium acnes Escherichia coli Enterobacter aerogenes Enterobacter cloacae complex 7 Klebsiella pneumoniae 8 Klebsiella oxytoca Klebsiella variicola 9 Proteus spp. 10 Non-fermenting bacteria Fungi Acinetobacter baumannii complex 11 Pseudomonas aeruginosa Candida spp. Candida albicans Candida glabrata Candida tropicalis Issatchenkia orientalis (Candida krusei) 1 incl. S. saprophyticus, S. hominis, S. epidermidis, S. warneri, S. haemolyticus, S. capitis, S. lugdunensis 2 incl. E. faecalis, E. faecium, E. gallinarum, E. casseliflavus, E. avium, E. hirae, E. durans, E. raffinosus 3 incl. S. pneumoniae, S. constellatus, S. agalactiae, S. pyogenes, S. anginosus 4 incl. A. hydrophila subsp. hydrophila, A. sobria, A. media, A. veronii, A. caviae 5 incl. B. fragilis, B. ovatus, B. thetaiotaomicron, B. uniformis 6 incl. B. fragilis, B. ovatus, B. heparinolyticus, B. pyogenes, B. thetaiotaomicron, B. uniformis, B. vulgatus, Parabacteroides distasonis, P. bivia, P. buccae, P. disiens, P. intermedia, P. jejuni, P. melaninogenica, P. nigrescens, P. oris, P. denticola 7 incl. E. cloacae, E. asburiae, E. hormaechei 8 incl. Klebsiella pneumoniae Cluster kp I + II, Alves et al., J Clin Microbiol, 44(10), 2006; 9 incl. Klebsiella variicola (Cluster kpiii; formerly K. pneumoniae, 2004 classified as its own species 10 incl. P. vulgaris, P. mirabilis, P. penneri, P. hauseri 11 incl. A. baumannii, A. oleivorans, A. calcoaceticus, A. pittii meca mecc vana vanb aaca4 ctx-m fosa3 mcr-1 nima nimb qnra qnrb qnrs teta kpc oxa-23 oxa-24/40 oxa-48 oxa-58 vim imp Oxacillin Oxacillin Vancomycin Vancomycin Aminoglycoside 3rd generation Cephalosporin Fosfomycin Polypeptides/polymyxins Nitroimidazole Nitroimidazole Fluoroquinolone Fluoroquinolone Fluoroquinolone Tetracycline tcdb Toxin B stx1/2 Shiga Toxin The comprehensive Unyvero Intra- Abdominal Infection panel covers many clinically relevant pathogens Universal Bacteria and Candida spp. and important antibiotic resistance markers and toxins ndm 12 Investigational Use. Not available for Sale in the United States. 13

8 native symple types Bile Ascites WIDE RANGE OF Native SAMPLE TYPES Overcoming challenges in diagnosing IAI Peritoneal fluid Tissue biopsy samples from blood culture bottles Swabs Intra-abdominal infections include a wide range of clinical pictures ranging from infections of the peritoneum, pancreas and colon, requiring the testing of many different and complex sample types, of various natures and qualities. The Unyvero IAI application improves the identification of pathogens and resistance genes in acute bacterial infections of the abdomen, and uniquely combines it with the detection of toxin markers in one test. It facilitates testing of ascites- and peritoneal fluid, pancreatic juice, as well as bile. Additionally, it handles e.g. catheter tips and drainage fluid, swabs tissue, and samples from positive flagged blood cultures. Compared to traditional IAI diagnostic measures, which are laborious and time consuming based on growing cultures and microscopy, multiple closely related nonpathogenic organisms, prior medication, and the number of involved pathogens no longer pose a problem. Drainage fluid 14 Investigational Use. Not available for Sale in the United States. 15

9 established technologies in a new format The Unyvero IAI Application combines all analytical steps in one closed test format, thus reducing the work involved for testing. Only a few simple manual steps allow simultaneous detection of various microorganisms, toxins, and antibioticresistance markers simultaneously in native patient samples and samples from positive flagged blood cultures within approximately five hours. DIVERSITY HIGHLY SPECIFIC MULTIPLEX PCR and FAST ARRAY-BASED DETECTION Pathogen DNA Specific Amplification Specific Target Hybridization Detection and Specific Control Sample Types Sample Quality One of Curetis core competencies is the design of reliable > liquid > samples cultured in blood culture bottles > tissue... Curetis proprietary and universal sample preparation technology prepares DNA from any native clinical sample type without losing time needed for preculturing. Because of its universal applicability The Curetis technology can use a single sample preparation protocol for many different sample types Of any clinical application bio-assays in self-contained cartridges to enable sensitive multiplex testing. The required multiplex grade is achieved by combining the unmatched sample preparation and PCR technology with a proprietary detection array. Endpoint- PCR can deliver higher multiplex grades than most other amplification methods, and in that respect holds clear advantages over e.g. real-time PCR. The array was optimized for hybridization times to only a few minutes compared to standard arrays. To enhance specificity, the dissociation kinetics of the array hybridization are automatically assessed. Additionally with each patient sample, an artificial gene is simultaneously processed as internal process control. The control verifies all PCR steps, as well as the array hybridization. Clostridium difficile toxin B Candida albicans 16 Investigational Use. Not available for Sale in the United States. 17

10 Unyvero Workflow Unyvero Workflow SPEED UNYVERO SOLUTION SIMPLIFIED WORKFLOW The intuitive simple workflow is consistent across all clinical applications and sample types, thus drastically reducing invalid tests due to operator errors. Step 1 Transfer of samples and lysis Step 2 Assembling the Unyvero Cartridge Step 3 Scanning and inserting the Unyvero Cartridge Step 4 Four to five hours analysis process Working time ~ 60 seconds: ~ 30 seconds: ~ 20 seconds: It takes just a few minutes for subsequent result analysis: 1. The patient sample is transferred to the Unyvero Sample Tube, sealed in with the Unyvero Sample Tube Cap, and lysed for 30 minutes in the Unyvero Lysator. 2. After 30 minutes the Unyvero Sample Tube is removed from the Lysator. Then the IAI Cartridge is assembled with the Unyvero Sample Tube and Unyvero Master Mix Tube. 3. The Cartride is scanned and insert into the Unyvero Analyzer. Two cartridges per analyzer can be analyzed simultaneously. 4. The Unyvero analysis runs for four to five hours. The results are displayed on the screen or can be exported as a PDF. 18 Investigational Use. Not available for Sale in the United States. 19

11 Unyvero System And Applications UNYVERO SYSTEM UNIVERSAL PLATFORM FEATURING MANY DIFFERENT APPLICATIONS The Unyvero Solution features a»sample to answer«approach and consists of: > the Unyvero L4 Lysator for sample lysis > the application specific Unyvero Cartridge > the Unyvero A50 Analyzer prozessing the Unyvero Cartridge > the Unyvero C8 Cockpit for intuitive user interaction The Unyvero System translates a complex laboratory process into an easy-to-use format. The analytical process requires merely the addition of the unprocessed patient sample and enzymes for DNA amplification. All other reagents are preloaded into a self-contained, contamination-safe cartridge. After the patient sample and the Master Mix are inserted into the cartridge, the cartridge is loaded into the analyzer and processed fully automatically. The Unyvero System generates complete diagnostic information in 4 5 hours, without any further operator interaction. 20 Investigational Use. Not available for Sale in the United States. 21

12 At A Glance UNyvero at a glance The Unyvero Solution > detects a broad panel of pathogens and antibiotic resistances, as well as toxins from a single sample in one run > enables the testing of many clinically relevant native samples > delivers clinically relevant information in 4 5 hours, helps with fact-based treatment decisions as early as possible > allows point of need testing > provides high productivity by - minimizing operator time to a few minutes with full walk-away automation, based on a simple and consistent workflow for any clinical application - low implementation requirements and low total ownership cost, as neither skilled molecular biology staff nor special infrastructure is needed - configurations that meet individual customer needs, satisfying processing time requirements - optimizing routine hospital workflow by sophisticated information management 22 Investigational Use. Not available for Sale in the United States. 23

13 Curetis GmbH Max-Eyth-Str Holzgerlingen Germany Tel.: +49 (0) Rev2.0 Curetis GmbH Investigational Use. Not available for Sale in the United States.