Enter Enter Alere ii Influenza Influenza A&B A&B Alere TM TM Molecular results in less than 15 minutes Molecular results in less than 15 minutes Transforming near-patient testing Unique isothermal amplification technology giving you molecular results, faster than ever before Unique Technology Improving patient outcomes Giving you the confidence to make effective clinical decisions sooner Faster Results Outstanding Performance Optimizing operational efficiency • Enables prompt initiation of infection control measures • Connected results direct to your network • Facilitating effective patient management Enabling effective Antimicrobial Stewardship Molecular sensitivity in an actionable timeframe allows the prudent use of antibiotics and antivirals Intuitive Design Antimicrobial Stewardship Ordering Information Alere i Influenza A&B TM A positive impact on your facility Reliable near-patient testing reduces overall healthcare costs4 Confidence at the point of care Intuitive and reliable, allowing you to respond quickly and accurately in any setting Alere i utilizes unique isothermal nucleic acid amplification technology which does not require temperature cycling or a sample purification step TM Unique Technology Faster Results Extraction Reverse Transcription Amplification Detection Result Test Results DD/MM/YY Tes t R es ults Outstanding Performance Patient: 10axj940 DD/MM/Y Y Alereuser1 User ID: P atient: 10axj940 Us er ID: Alereus er1 A: Negative FluFlu A: Negative 11:22 am P rocedural C ontrol Valid 11:22 am Procedural Control Valid Flu B: Positive Flu B: Positive New Tes t New Test P rint Print Intuitive Design 0 min Antimicrobial Stewardship Ordering Information Alere i Influenza A&B TM <15 min Alere i is significantly faster than other molecular methods and more accurate than conventional rapid testing giving you the confidence to make effective patient management decisions sooner TM Unique Technology Faster Results Modern Molecular System Outstanding Performance Conventional Real-Time PCR Viral Culture Intuitive Design Antimicrobial Stewardship Ordering Information Alere i Influenza A&B TM 0m 15m 30m 45m 1h 2h 3h 4h 12h 24h “Alere i demonstrates impressive sensitivity for the detection of both influenza A and B in clinical respiratory specimens obtained from children and adults” 3 TM Unique Technology Alere i Influenza A & B Performance vs. Culture1 TM Sensitivity Faster Results Influenza A Outstanding Performance Intuitive Design Influenza B Specificity 97.9% 86.2% (95% CI: 92.6%, 99.4%) (95% CI: 82.8%, 89.0%) 92.5% 96.5% (95% CI: 84.6%, 96.5%) (95% CI: 94.5%, 97.8%) Alere i Influenza A & B Performance vs. Culture1 Discrepant result resolved by RT-PCR TM Antimicrobial Stewardship Sensitivity Influenza A Ordering Information Influenza B Specificity 99.3% 98.1% (95% CI: 96.3%, 99.9%) (95% CI: 96.3%, 99.9%) 97.8% 99.6% (95% CI: 92.3%, 99.4%) (95% CI: 98.5%, 99.9%) *All specimens generating discrepant results between the Alere i Influenza A & B test and viral culture were tested using an FDA cleared RT-PCR assay to confirm influenza status. Performance of Alere i Influenza A & B when the results of PCR on discrepant samples are incorporated is presented in the table above. TM TM Alere i Influenza A&B TM “A simple and easy to use molecular diagnostic test”2 Sample type nasal swab Unique Technology Visual touchscreen no need for separate instructions Easy to use requires only minimal training Small footprint can be used in any healthcare setting Streamlined workflow connectivity can be provided to your network Faster Results 145 mm / 5.71” Outstanding Performance Intuitive Design Antimicrobial Stewardship Ordering Information Alere i Influenza A&B ” Test Base Sample Receiver Transfer Cartridge 207 mm 4 / 8.15” TM Simple Easy to Use In Any Setting 19 mm / 4 7.6 Easy to use with a simple touch screen Home Unique Technology Faster Results 6/Feb/2014 12:00pm Run Test Run QC Test Review Memory Preferences Setup Log Out Outstanding Performance Intuitive Design Antimicrobial Stewardship Run Test Test Results Remove seal. Mix swab for 10 seconds and discard the swab DD/MM/YY Patient: 10axj940 User ID: Alereuser1 (6:37) Flu B: Positive Ordering Information Alere i Influenza A&B Step 4 of 6 11:22 am Procedural Control Valid Flu A: Negative New Test Print TM Simple Easy to Use In Any Setting Suitable for use in any healthcare setting Unique Technology Faster Results Outstanding Performance Intuitive Design Antimicrobial Stewardship Emergency Department Laboratory Physician's Office Ordering Information Alere™ i products are Moderately Complex. Alere i Influenza A&B TM Simple Easy to Use In Any Setting Unique Technology Faster Results Outstanding Performance Intuitive Design Antimicrobial Stewardship Ordering Information Alere i Influenza A&B TM The Test Target Treat antimicrobial stewardship initiative from Alere empowers you to make targeted treatment decisions sooner with rapid diagnostics; reducing the inappropriate use of antibiotics and antivirals, and the spread of resistance. TM Find out more at TestTargetTreat.com Visit Alere-i.com today or contact us: [email protected] Unique Technology Faster Results Outstanding Performance 23046617 23046618 23046619 Alere i Instrument Alere i Influenza A & B 24 Test Kit, CPT: 87502 Alere i Influenza A & B Control Swab Kit Alere i Barcode Scanner Alere Universal Printer ™ ™ ™ EQ001001 55115 ™ ™ References: Intuitive Design 1. Alere i Influenza A & B Package Insert. 2. Bell, J. and Selvarangan, R. Evaluation of the Rapid Alere i Influenza A & B Nucleic Acid Amplification Test Using Respiratory Specimens Collected in Viral Transport Medium. Poster presented at Clinical Virology Symposium. (2013) Children’s Mercy Hospitals and Clinics, and University of Missouri, Kansas City School of Medicine, Kansas City, MO 3. Bell, J. et al. (2013) Clinical Evaluation of the Alere i Influenza A & B Assay, a Point-of-Care Rapid Nucleic Acid Amplification Test for Detection of Influenza. Children’s Mercy Hospitals and Clinics and University of Missouri Kansas City School of Medicine, Kansas City, MO. Veritas, P.A., Belton, TX. Nationwide Children’s Hospital, Columbus, OH. New York Methodist Hospital, Brooklyn, NY. Ann & Robert Lurie Children’s Hospital of Chicago and Northwestern University Feinberg School of Medicine, Chicago, IL. Albany Medical College, Albany, NY. Wake Forest University Baptist Medical Center, Winston-Salem, NC. 4. Bonner, A.B. et al. (2003) Impact of the Rapid Diagnosis of Influenza on Physician Decision-Making and Patient Management in the Pediatric Emergency Department: Results of a Randomized, Prospective, Controlled Trial. Pediatrics Vol. 112 No. 2. ™ ™ ™ Antimicrobial Stewardship Ordering Information Alere i Influenza A&B TM © 2014 Alere. All rights reserved. The Alere Logo, Alere, Molecular. In minutes. and Test Target Treat are trademarks of the Alere group. 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