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AMPLISureTM Gastro Gastrointestinal Pathogen Testing 1 Sample, 1 Test, 11 Results Confidence in results. Gastroenteritis: A Serious Medical and Economic Burden A variety of bacterial, viral, and parasitic organisms cause infectious gastroenteritis • Diagnostically it’s difficult to differentiate due to similar symptoms1,2 • 80% of all cases of diarrhea are currently unidentified2 Diarrhea inflicts a significant toll on the health care system and imparts a high degree of morbidity and mortality in select populations3 • Globally, there are an estimated 2 billion cases of diarrheal disease every year which kill approximately 1.8 million people annually4 • In 2010, the U.S. associated cost for the 237,000+ patients suffering from gastrointestinal infections was over $6 billion5 Consequence of outbreaks of gastroenteritis in hospitals 6 • Hospital ward closures and major disruption in hospital activity (e.g. bed blocking, loss of revenue) Diarrhea can also have a major impact in society • Significant number of days lost at school or work Inappropriate and irrational use of medicines provides favorable conditions for resistant microorganisms to emerge and spread ble • When infections become resistant to first-line medicines, more expensive therapies must be used. • The longer duration of illness and treatment, often in hospitals, increases health-care costs and the financial burden to families and societies7 The Largest FDA-approved panel for 11 of the Most Common Causes of Infectious Diarrhea AMPLISureTM Gastro, Gastro LT, and Gastro O&P: • Get Fast, Comprehensive Results: Detect and identify ≥90% of the causative bacterial, viral and parasitic agents of gastroenteritis2,8 • Simplify Your Detection Process: One test provides answers for 11 pathogens as well as routine flora screening • Flexible ordering capabilities: The full Gastro panel, Gastro LT (traditional stool culture), and Gastro O&P Bacteria & Bacterial Toxins Viruses Parasites Campylobacter Norovirus GI/GII Giardia lamblia Clostridium difficile, Toxin A/B with reflex to Epi 027/NAP1/Bl ribotyping Rotavirus A Cryptosporidium Escherichia coli O157 Ova and Parasites Screen Enterotoxigenic E. coli (ETEC) LT/ST Shiga-like Toxin producing E. coli (STEC) stx 1/stx 2 Salmonella Shigella Routine flora screening AMPLISureTM Gastro MedLabs Test Code: P2002MG Specimen Requirement: Stool (sterile container) Specimen Stability: 24 hours @ 2-4 degrees C Components: All but manual O&P screen AMPLISureTM Gastro LT MedLabs Test Code: P2002MG Specimen Requirement: Stool (sterile container) Specimen Stability: 24 hours @ 2-4 degrees C Components: Campylobacter, E. coli O157, STEC, Salmonella, Shigella, flora screen AMPLISureTM Gastro O&P MedLabs Test Code: P2002MG Specimen Requirement: Stool (sterile container) Specimen Stability: 24 hours @ 2-4 degrees C Components: Giardia, Cryptosporidium, O&P screen GI Diagnostic Challenges and Clinical Consequences Accurate detection of GI pathogens may improve patient outcomes, isolate patients appropriately, and act fast in outbreak situations. Challenge Consequence Solution AMPLISureTM Gastro simultaneously detects and identifies the bacterial, viral, and parasitic pathogens responsible for over 90% of cases of infectious diarrhea2 • Patient treatment can be optimized more quickly with improved outcomes • Many causative agents of diarrhea that are difficult to diagnose as symptoms are similar • Risk of delayed or wrong patient treatment • Risk of improper and ineffective treatment with side effects, patient anxiety, inappropriate use of antibiotics and potential for antibiotic resistance • • Traditional laboratory methods are not sensitive or specific enough. Moreover, not all samples are tested for all diarrhea-causing pathogens. Together this results in a false negative test result. • Risk of delayed or wrong patient treatment • Pressure on isolation facilities until results are available. Potential for outbreaks if patients with communicable infectious gastroenteritis are not isolated • Current methodologies and requesting patterns mean that some results can take more than 1 week • Control and prevention of outbreaks • • • Incorrect diagnosis impacting treatment and bed isolation management • Treatment side effects, antibiotic resistance, patient anxiety • Prolonged needless isolation or lack of isolation with risk of outbreaks AMPLISureTM Gastro provides higher and better diagnostic yield for more appropriate patient management • Optimized bed management helps to reduce costs and frees up beds for new patients requiring isolation AMPLISureTM Gastro’s high negative predictive value affords the ability to rule out >90% of the infectious causes of diarrhea AMPLISureTM Gastro: Designed for Patient Assurance A negative predictive value of 99.9% gives confidence in the value of a negative result. Analyte True Negative (TN) Specimens (n) False Negative (FN) Specimens (n) Estimated NPV: TN/ (TN + FN) Campylobacter 1155 0 100% Cryptosporidium 1131 1 99.9% E. coli O157 1158 0 100% Giardia 1132 0 100% Norovirus GI/GII 1023 4 99.6% Salmonella 1143 0 100% Shigella 1154 0 100% C. difficile Toxin A/B 922 7 99.2% ETEC 1156 6 99.5% Rotavirus A 1162 0 100% STEC 1153 0 100% 12289 18 All Analytes 99.9% AMPLISureTM Gastro: Transforming GI Diagnostics 1 Sample, 1 Test, 11 Results – More results per test than any other method, in time to affect patient care. Method Tests For Percent Positive Stool culture Single or a few bacterial pathogens per test Up to 6% (Slutsker, 1997) Ova & parasite (O&P) exam Parasitic pathogens Up to 3% (Fotedar, 2007; Tuncay 2007) Rapid tests Single pathogen per test Varies Real-time PCR Typically 1-3 pathogens/virulence factors per test Varies; depends on the pathogen target, performance of assay, and number of assays ELISA Single antigen/antibody per test Varies 11 baterial, viral, and parasitic pathogens in a single test as well as routine flora screening Greater than or equal to 35%- All 11 targets (Luminex Corp., 2013) AMPLISure TM Gastro REFERENCE: 1. 2. 3. 4. 5. 6. 7. 8. World Gastroenterology Organisation practice guideline: Acute diarrhea, March 2008. (http://www.worldgastroenterology.org/assets/downloads/en/pdf/guidelines/01_acute_diarrhea.pdf ) CDC, National Center for Zoonotic, Vector-borne and Enteric Diseases. Bern et al. 1992. The magnitude of the global problem of diarrheal disease: a ten-year Update Bulletin. World Health Organisation. 70:705–714. http://www.who.int/mediacentre/factsheets/fs330/en/index.html U.S. Dept. of Health and Human Services. (2010). National Statistics on Intestinal Infections. Chadwick P.R. et al. Journal of Hospital Infections (2000) 45:1-10.6. Fact sheet no. 194 about microbial resistance at www.who.int/mediacentre/factsheets/ Luminex Corp. (2013). U.S. Clinical Site Data. xTAG GPP Package Insert. For more information about gastroenteritis, visit www.gastroenteritis.com or visit www.medlabsgenetics.com To learn more about the U.S. trials, go to www.luminexcorp.com/GIAnswers. For In Vitro Diagnostic Use. Reagents available through the Luminex Corporation. ©2013 MedLabs Genetics. All rights reserved. The AMPLISure TM trademark and all logos and images contained within are the property of MedLabs Genetics. MEDLABS GENETICS Proud affiliate of MedLabs Diagnostics 85 Horsehill Rd, Ste 110 Cedar Knolls, NJ 07927 Tel: 973-419-6828 Fax: 512-219-5195 www.medlabsgenetics.com