See How CoaguChek Technology Sets The Bar For Outcomes-focused .

Transcription

See how CoaguChek technology sets the barfor outcomes-focused, standardized care

Standardized care starts with a single-strip platform forconsistently accurate results across the care continuum—including patient self-testing.Only CoaguChek PT test strip technology provides:Highest correlation (97%)to lab results1 for confidencein therapy decisionsBuilt-in anti-heparin agent foraccuracy across the heparin/LMWH therapeutic range1Special “misuse detector”(Resazurin) in the samechamber as patient testLarge, direct-to-teststrip dosing area foreasy sample applicationTop- and side-dosingoptions to help meetindividual preferencesWhy this matters:Why this matters:Why this matters:Why this matters:Why this matters:Lifetime per-patient cost for astroke in the U.S. is estimated atmore than 140,0002One in 10 warfarin patients mayrequire post-operative heparin/LMWH“bridging” annually3,4Helps ensure accurate results bydetecting humidity, temperatureand other environmental factorsthat could compromise stripintegrityOlder patients may strugglewith blood application—andabout 57% of patients withheart disease also havearthritis5No cups, pipettes or cartridgesto impede efficient testing

See why the CoaguChek brand isthe clear choice for standardizationCoaguChek solution:Mid- to high-volume professionalsystem with data management andconnectivity options as well as barcodescanner for enhanced patient safetyCLIA-waivedCLIA-waived Coag-SenseE ITC ProTime SystemSystemiSTAT Analyzer CoaguChek XSPro systemMid- to high-volume, CLIA-waivedprofessional system with datamanagement and connectivity optionsfor care coordinationCoaguChek XSPlus systemLow- to mid-volume, CLIA-waivedprofessional system with datamanagement and connectivity optionsfor care coordinationCoaguChek XSsystemPatient self-testing solution withArthritis Foundation Ease-of-UseCommendation for higher patientsatisfactionCoaguChek XSsystemSingle-strip platform with 97%correlation to lab results and insensitivityto heparin (up to 0.8 U/mL) and LMWH(up to 2 IU/mL)1 for optimal patientsafetyINRatio 2System All CoaguCheksystems

Falsely elevated INR values due to heparinsensitivity may precipitate prematurecessation of heparin therapy and putpatients at risk for recurrent thrombosis 15

CoaguChek XS System1,6CoaguChek XS Plus System1,7 CoaguChek XS Pro System1,8INRatio 2 System9,10For professional or patient home useFor professional useFor professional use97%197%197%193%3Earned the Arthritis FoundationEase-of-Use Commendation 4Less blood required8 μL8 μL8 μL15 μL5Blood application time3 minutes3 minutes3 minutes3 minutes6On-screen countdown to result 7Flexible dosing1Correlation to lab results2Neutralizes therapeutic levels ofheparin/LMW heparin8Time to result9CV% (therapeutic capillary)10Data storage (memory)11Sample applied directly to top Sample applied directly to top Sample applied directly to topor side of stripor side of stripor side of stripSample applied directly totop of strip only 1 min 1 min 1 min 1 min4.40%4.40%4.40%5.90%300 results2,000 results2,000 results120 resultsTest strip shelf lifeUntil printed expiration dateUntil printed expiration dateUntil printed expiration dateUntil printed expiration date12Test strip storage36 F – 86 F36 F – 86 F36 F – 86 F35 F – 90 F13CLIA-waived14Approved for patient self-testing 15Weight of device (w/batteries)6.2 oz.14.2 oz.15.6 oz.9.3 oz.16Connectivity17Barcode reader 18Hematocrit range25-55%25-55%25-55%30-55%19Interfering factorsBilirubin: 30 mg/dLHemoglobin/hemolysis:1,000 mg/dLLipemia/triglycerides:500 mg/dLBilirubin: 30 mg/dLHemoglobin/hemolysis:1,000 mg/dLLipemia/triglycerides:500 mg/dLBilirubin: 30 mg/dLHemoglobin/hemolysis:1,000 mg/dLLipemia/triglycerides:500 mg/dLBilirubin: 20 mg/dLHemoglobin/hemolysis:500 mg/dLLipemia/triglycerides:1,500 mg/dL20System operating temp59 F – 90 F59 F – 90 F59 F – 90 F50 F – 95 F21Humidity 85% 85% 85%10-95%

ITC ProTime System11,1294% 27 μL (3 chamber)65 μL (5 chamber)2 min 10 sec Sample must fill cup onTenderlett Plus, then beattached to cuvette5 minN/A50 results60 days (room temperature);until printed expiration dateif refrigerated36 F – 46 F 1.6 lbs. 20-60%N/A59 F – 86 F 30%

Coag-Sense System1392% 10 μL2 min Sample applied usingmini-pipette or sampletransfer tubes 1 min2.60%100 resultsUntil printed expiration date35 F – 90 F 1.2 lbs. 15-60%Bilirubin: 20 mg/dLHemoglobin/hemolysis:500 mg/dLLipemia/triglycerides:3,000 mg/dL65 F – 90 F10-85%

iSTAT Analyzer1496%Insensitive to heparinup to 1.0 U/mL 20 μLImmediately(blood goes into cartridge) Sample applied directly tocartridge5 min4.60%1,000 resultsUntil printed expiration date35 F – 46 F (requires 5 minto warm up to room temp) 22.9 oz. w/rechargeable battery22.4 oz. w/disposable battery 25-54%N/A61 F – 86 F 90%

ReferencesCoaguChek XS PT Test [package insert 05967694001(01)]. Indianapolis, Ind.: Roche Diagnostics; 2010.Go AS, Mozaffarian D, Roger V, et al. Heart Disease and Stroke Statistics—2013 Update: A Report From The American Heart Association. Circulation. 2013;127:e6-e245.3 Douketis JD, Spyropoulos AC, Spencer FA, et al. Perioperative Management of Antithrombotic Therapy: Antithrombotic Therapy and Prevention of Thrombosis. American College ofChest Physicians Evidence-Based Clinical Practice Guidelines. 9th ed. Chest. 2012;141:e326S–e350S.4 Douketis JD, Berger PB, Dunn AS, et al. The Perioperative Management of Antithrombotic Therapy. American College of Chest Physicians Evidence-Based Clinical PracticeGuidelines. 8th ed. Chest. 2008;133(6 suppl):299S–339S.5 National Center for Chronic Disease Prevention and Health Promotion. Arthritis at a Glance: Meeting the Challenge of Living Well. 2012. Available at http://www.cdc.gov. AccessedApril 5, 2013.6CoaguChek XS System User Manual [04837991001(04)]. Indianapolis, Ind.: Roche Diagnostics; 2011.7CoaguChek XS Plus System User Manual [05021464001 (05)]. Indianapolis, Ind.: Roche Diagnostics. 2012.8CoaguChek XS Pro System Operator’s Manual [05914639001 (02)]. Indianapolis, Ind.: Roche Diagnostics. 2012.9INRatio 2 PT/INR Professional Testing System User Guide. [PN 26047en Rev. A 2010/07/22]. San Diego, Cal.: Alere San Diego, Inc.; 2010.10INRatio PT/INR Test Strips [package insert PN 26051 Rev. C]. San Diego, Cal.: Alere San Diego, Inc.; 2011.11ITC Professional User Manual [IR5246]. Edison, N.J.: International Technidyne Corporation; 2008.12ITC ProTime Cuvette [package insert IR5259]. Edison, N.J.: International Technidyne Corporation; 2008.13Coag-SenseE test strip [package insert APOC ART023108 Rev. A 06/10]. Fremont, Cal.: CoaguSense, Inc. 2010.14iStatT 1 System Manual. [714336-00L]. Abbott Park, Ill.: Abbott Point of Care Inc.; 2012.15Leech BF and Carter CJ. Falsely elevated INR results due to the sensitivity of a thromboplastin reagent to heparin. Am J Clin Pathol. 1998;109(6):764-768.12COAGUCHEK is a trademark of Roche. All other product names andtrademarks are property of their respective owners. 2013 Roche. 339-52569-0613Roche Diagnostics Corporation9115 Hague RoadIndianapolis, IN 46256www.coaguchek.com

7 CoaguChek XS Plus System User Manual [05021464001 (05)]. Indianapolis, Ind.: Roche Diagnostics. 2012. 8 CoaguChek XS Pro System Operator's Manual [05914639001 (02)]. Indianapolis, Ind.: Roche Diagnostics. 2012. 9 INRatio 2 PT/INR Professional Testing System User Guide. [PN 26047en Rev.