Contents:

1. Overview 14 1.1 About this Report 14 1.2 Scope of the Report 15 1.3 Objectives 16 1.4 Methodology 16 1.5 Executive Summary 17 2. Overview of Diagnostic Testing Point of Care 21 2.1 Point of Care Testing Sites 21 2.2 Point of Care Market Structure 22 2.3 New Directions in Clinical IVD Testing 22 3. POCT and Rapid Testing Market Analysis: Size, Background Analysis, Growth, Share and Competitors 25 3.1 Global POCT Market 31 3.2 U.S. POCT Market 34 3.3 European POCT Market 37 3.3.1 German POCT Diagnostic Market 43 3.3.2 U.K. POCT Diagnostic Market 45 3.3.2.1 U.K. POCT Market Statistics 45 3.3.2.2 U.K. Competitive Analysis 47 3.3.2.3 U.K. Market Access 48 3.3.3 French POCT Diagnostic Market 48 3.3.4 Italian POCT Diagnostic Market 49 3.3.5 Spanish POCT Diagnostic Market 51 3.3.6 Scandinavian POCT Diagnostic Market 52 3.3.7 Swedish POCT Diagnostic Market 53 3.3.8 Finnish POCT Diagnostic Market 54 3.3.9 Norwegian POCT Diagnostic Market 55 3.3.10 Swiss POCT Diagnostic Market 56 3.3.11 Dutch POCT Diagnostic Market 57 3.3.12 Belgian POCT Diagnostic Market 58 3.3.13 Portuguese POCT Diagnostic Market 59 3.3.14 Austrian POCT Diagnostic Market 60 3.3.15 Greek POCT Diagnostic Market 61 3.3.16 Polish POCT Diagnostic Market 62 3.3.17 Czech Republic POCT Diagnostic Market 63 3.3.18 Turkish POCT Diagnostic Market 64 3.4 Asian POCT Markets 64 3.4.1 Japanese POCT Diagnostic Market 64 3.4.2 Indian POCT Diagnostic Market 66 3.4.3 Chinese POCT Diagnostic Market 71 3.5 Rest of the World POCT Market 81 3.5.1 Canadian POCT Diagnostic Market 82 3.5.2 Brazilian POCT Diagnostic Market 82 3.5.3 Australian POCT Diagnostic Market 83 3.6 Overview of Asian Healthcare Market 83 3.6.1 Singapore 85 3.6.2 Malaysia 85 3.6.3 Thailand 86 3.6.4 Indonesia 86 3.6.5 Philippines 86 3.6.6 South Korea 87 3.6.7 Taiwan 87 4. POCT Individual Markets 88 4.1 Glucose Testing 88 4.2 POCT Individual Market Sectors, Size, Growth Rates and Competitors 89 4.2.1 World Market Revenue and Forecasts 89 4.2.2 Professional Glucose Testing Market for POCT U.S. Revenue and Forecasts during 2001-2012 90 4.2.3 European Market 91 4.2.4 Market Share 91 4.2.5 Alternate Glucose Monitoring Products 92 4.2.6 HbA1c POCT 93 4.2.7 Market Challenges and Strategic Recommendations 94 4.2.7.1 Market Drivers and Restraints 94 4.2.7.1.1 Market Drivers 94 4.2.7.1.2 Market Restraints 94 4.2.7.2 Point of Care Glucose Testing Assay Market and Technology Trends 95 4.2.7.2.1 Point of Care Glucose Testing Assay Market Trends 95 4.2.7.2.2 Point of Care Glucose Testing Assay Technology Trends 95 4.2.7.2.3 Point of Care Glucose Testing Assay Strategic Recommendations 95 4.3 Blood Gas and Electrolytes 96 4.3.1 Whole Blood Lactate 99 4.4 Rapid Coagulation Tests 99 4.4.1 World POCT Coagulation Market 102 4.4.2 U.S. Coagulation Market 102 4.4.3 European Coagulation Market 106 4.4.4 Trends in POCT Coagulation Testing 106 4.4.4.1 Self-testing Coagulation Market 106 4.4.4.2 D-Dimer Testing 107 4.4.5 Point of Care Coagulation Testing Assay Market and Technology Trends 107 4.4.5.1 Point of Care Coagulation Testing Assay Market Trends 107 4.4.5.2 Point of Care Coagulation Testing Assay Technology Trends 108 4.4.5.3 Point of Care Coagulation Testing Assay Strategic Recommendations 108 4.5 Rapid Cardiac Markers 109 4.5.1 U.S. Market 109 4.5.2 European Market 111 4.5.3 Market Drivers and Restraints 113 4.5.3.1 Market Drivers 113 4.5.3.2 Market Restraints 113 4.5.4 Point of Care Cardiac Marker Testing Assay Market and Technology Trends 113 4.5.4.1 Point of Care Cardiac Marker Testing Assay Market Trends 113 4.5.4.2 Point of Care Cardiac Marker Testing Assay Technology Trends 114 4.5.4.3 Point of Care Cardiac Marker Testing Assay Strategic Recommendations 114 4.6 Drugs of Abuse Screening Testing 114 4.6.1 Acetaminophen 121 4.6.2 Tricyclic Antidepressants (TCAs) 122 4.6.3 Other Toxic Drugs 122 4.6.4 Drug Testing Selectivity 122 4.6.5 Methaqualone and Phencyclidine (PCP) 123 4.6.6 Tetrahydrocannabinol 123 4.6.7 Drug Panels by Toxidromes 123 4.6.8 Alcohol Testing 123 4.7 Urine Strips 124 4.8 Pregnancy Tests 127 4.9 Fecal Occult Blood 128 4.10 Hemoglobin Testing 129 4.11 Miscellaneous Rapid Tests 130 4.11.1 Estriol 130 4.11.2 Fetal Fibronectin (fFN) 131 4.11.3 H. pylori 131 4.11.4 Vaginal pH and Vaginitis 131 4.11.5 Bladder Cancer 132 4.11.6 Fetal Status 133 4.11.7 Heparin-induced Thrombocytopenia 133 4.12 Human Immunodeficiency Virus (HIV) 133 4.13 Cholesterol 140 4.14 Infectious Disease 141 4.14.1 Clostridium difficile 141 4.14.2 Giardia 142 4.14.3 Salmonella and Campylobacter 143 4.14.4 Malaria Testing 143 4.14.5 Influenza Testing 144 4.14.6 Strep Testing 148 4.14.7 Chlamydia 149 4.14.8 Mononucleosis 150 4.14.9 Rubella 150 4.14.10 Methicillin-resistant Staphylococcus aureus (MRSA) 151 4.14.11 Hepatitis 156 4.14.12 Gonorrhea 158 4.14.13 Tuberculosis (TB) 158 4.14.14 Herpes Simplex Virus Type-2 160 4.14.15 Legionella 160 4.14.16 RSV 161 4.14.16.1 Market Drivers and Restraints 163 4.14.16.1.1 Market Drivers 163 4.14.16.1.2 Market Restraints 163 4.14.16.2 Point of Care Infectious Disease Testing Assay Market and Technology Trends 164 4.14.16.2.1 Point of Care Infectious Disease Testing Assay Market Trends 164 4.14.16.2.2 Point of Care Infectious Disease Testing Assay Technology Trends 164 4.14.16.2.3 Point of Care Infectious disease Testing Assay Strategic Recommendations 164 4.15 Infant Jaundice 164 4.16 Anthrax 165 4.17 Rupture of Fetal Membranes (ROM) 167 4.18 Food Pathogens 167 4.19 Typhoid 167 5. POCT: Reagents and Equipment 168 5.1 Blood Glucose Monitoring 168 5.1.1 LifeScan 169 5.1.2 Roche Accu-Chek 172 5.1.3 Abbott Diabetes Care 174 5.1.4 HemoCue 175 5.1.5 Stanbio/GDS Technology 175 5.1.6 Abaxis, Inc. 176 5.1.7 Arkray (Japan) 176 5.1.8 Accurex (India) 177 5.1.9 Home Diagnostics, Inc. 177 5.1.10 Nova Biomedical 177 5.1.11 Bayer 177 5.1.11.1 Hemoglobin A1c Measurements 179 5.1.12 Biosite (now part of Alere) 179 5.1.13 Siemens Healthcare Diagnostics 179 5.1.14 Infopia 179 5.1.15 Diasys 179 5.1.16 Quotient Dx 180 5.1.17 Cholestech (Acquired by Inverness Medical Innovations, now named Alere) 180 5.1.18 Bio-Rad 180 5.1.19 Axis-Shield 180 5.2 Blood Gas and Electrolytes 180 5.2.1 Roche Corporation 180 5.2.2 TechnoMedica 180 5.2.3 Siemens Healthcare Diagnostics 181 5.2.4 Instrumentation Laboratory 181 5.2.5 Nova Biomedical 182 5.2.6 Radiometer 182 5.2.7 Abbott Laboratories 182 5.2.8 Span Diagnostics 183 5.2.9 Nexus Dx Avoximeter Systems for Co-oximetry 183 5.2.10 ITC (Nexus Dx) 184 5.2.11 Alere 185 5.3 Rapid Coagulation Tests 185 5.3.1 POC Coagulation Instrument Description 189 5.3.1.1 Roche Diagnostics Corp. 190 5.3.1.2 Abbott Laboratories 191 5.3.1.3 International Technidyne Corporation 192 5.3.1.4 Medtronic 193 5.3.1.5 HemoSense (Inverness) 194 5.3.1.6 Helena Laboratories Point of Care 194 5.3.1.7 Sienco, Inc. 195 5.3.1.8 Accumetrics 196 5.3.1.9 Alere 196 5.3.2 Connectivity Issues 196 5.3.3 Cost Benefits 197 5.3.4 Quality Control Issues 197 5.3.5 Certification for Point of Care Coagulation Devices 198 5.4 Rapid Cardiac Markers 198 5.4.1 Biosite Diagnostics (Inverness, now called Alere) 198 5.4.2 Roche Diagnostics 199 5.4.3 Ani Biotech 200 5.4.4 Response Biomedical Corporation 201 5.4.5 Siemens Healthcare Diagnostics (f/k/a Bayer Healthcare Diagnostics, Diagnostic Products Corporation, and Dade Behring) 202 5.4.6 Lab21 Ltd. 202 5.4.7 Abbott Laboratories 202 5.4.8 LifeSign (Princeton BioMediTech Corp.) 202 5.4.9 Mitsubishi Kagaku Iatron 202 5.4.10 Alpha Scientific 202 5.5 Rapid Drugs of Abuse 203 5.5.1 Biosite Diagnostics (Inverness, now called Alere) 204 5.5.2 Abbott Diagnostics 205 5.5.3 Roche Diagnostics 205 5.5.4 BioScan Screening Systems, Inc. 206 5.5.5 American Bio Medica Corp. 206 5.5.6 Phamatech, Inc. 210 5.5.7 First Check Medical 210 5.5.8 OraSure 211 5.5.9 Avitar, Inc. 211 5.5.10 Concateno 212 5.5.11 Pathtech 212 5.5.12 Alfa Scientific Designs, Inc. 212 5.5.13 TCPI, Inc. 213 5.5.14 Roche 213 5.5.15 Biophor Diagnostics 213 5.6 Rapid Pregnancy and Fertility Tests 213 5.7 Fecal Occult Blood 215 5.7.1 Helena Laboratories 216 5.7.2 Biomerica 216 5.7.3 Beckman Coulter 216 5.7.4 Worldwide Medical 216 5.7.5 Aerscher Diagnostics 217 5.7.6 Enterix 217 5.7.7 Medix Biochemica 217 5.7.8 Orion Diagnostica 218 5.8 Hemoglobin Testing 218 5.8.1 Wampole Laboratories 218 5.8.2 HemoCue, Inc. 218 5.8.3 Stanbio 218 5.9 Miscellaneous Rapid Tests 218 5.9.1 Triage C. difficile Panel 218 5.9.2 Ketoacids 219 5.9.3 Acetaminophen 219 5.9.4 Estriol 219 5.9.5 H. pylori 220 5.9.6 Vaginal Fluid pH and Vaginitis 222 5.9.7 Prostate-specific Antigen (PSA) 222 5.9.8 Bladder Cancer 223 5.9.9 Other Rapid Cancer Tests 226 5.9.10 Fetal Status (PROM) 227 5.9.11 Osteoporosis 227 5.9.12 Hemodynamic Monitoring 227 5.9.13 Heparin-induced Thrombocytopenia 227 5.10 HIV 228 5.10.1 Whole Blood, Serum or Plasma-based HIV Tests 230 5.10.1.1 Bio-Rad Laboratories 230 5.10.1.2 Orgenics (Inverness, now called Alere) 230 5.10.1.3 StatSure Diagnostic Systems 231 5.10.1.4 Trinity Biotech 231 5.10.1.5 Savyon Diagnostics 231 5.10.1.6 MedPharm 231 5.10.1.7 American Bio Medica Corp. 232 5.10.1.8 Chembio Diagnostics 232 5.10.1.9 OraSure Technologies 232 5.10.1.10 Inverness (Alere) 233 5.10.2 Saliva-based HIV Tests 233 5.10.2.1 OraSure Collection Device 234 5.10.2.2 SureStat 235 5.10.3 Urine-based HIV Tests 235 5.10.3.1 MedMira Laboratories, Inc. 235 5.10.3.2 Medical Services International, Inc. 236 5.10.3.3 Maxim Biomedical 236 5.10.3.4 Wampole Laboratories 237 5.11 Cholesterol 237 5.11.1 Cholestech (now a brand of Inverness Medical Innovations) 237 5.11.2 Actimed Laboratories 238 5.11.3 StatSite Meter 239 5.11.4 Polymer Technology Systems 239 5.11.5 PreMD, Inc. (f/k/a International Medical Innovations, Inc. [IMI]) 239 5.11.6 Abaxis, Inc. 239 5.12 Infectious Disease 240 5.12.1 C. difficile 240 5.12.2 Giardia 240 5.12.3 Dengue Fever 241 5.12.4 Malaria Testing 241 5.12.5 Rapid Influenza Testing 243 5.12.6 Streptococcus Testing 246 5.12.7 Chlamydia 248 5.12.8 Mononucleosis 248 5.12.9 Rubella 250 5.12.10 Staphylococcus aureus and MRSA 250 5.12.11 Hepatitis 251 5.12.12 E. Coli O157 253 5.12.13 Gonorrhea Testing 253 5.12.14 Smallpox 253 5.12.15 SARS 253 5.12.16 Rabies 254 5.12.17 Tuberculosis 254 5.12.18 Avian Flu 254 5.12.19 West Nile Virus 254 5.12.20 Herpes Simplex Virus Type-2 255 5.12.21 Legionella 255 5.12.22 RSV 255 5.13 Infant Jaundice 256 5.14 Anthrax 257 5.15 Homeland Defense (Plague and Tularemia) 259 5.16 BSE (Mad Cow Disease) 259 5.17 Tuberculosis 259 5.18 Typhoid 260 5.19 Avian Flu 260 5.20 Food Pathogens (Salmonella, Listeria, Campylobacter) 260 5.21 Ruptured Fetal Membranes (ROM) 261 6. POCT: Growth Regulators 263 6.1 Moderators of Growth 263 6.2 Personnel Acceptance 263 6.3 Key People for POCT 264 6.4 Information Management Issues 264 6.4.1 Elements of Information Management for POCT: Information Processing Capabilities 266 6.4.2 Data Mining 266 6.4.3 Middleware 266 6.4.4 Web Portals 267 6.4.5 POCT-1A Standard 267 6.5 Key Elements for POCT 268 6.6 POCT and Reimbursement 268 6.7 Effectiveness of Clinical Outcomes 270 6.8 Rapid Near-Patient Testing in Hospitals 271 6.9 Satellite Facilities 271 6.10 Regionalization of Laboratory Care 272 6.11 Requirements for POCT 273 6.12 Locations of Point of Care for Patient Care 274 6.13 Benefits of POCT 274 6.14 Cost Elements of POCT 275 6.15 Necessary Functions in POCT 275 6.16 TAT for POCT 275 6.17 Clinical Laboratory Improvement Amendments (CLIA) 276 6.18 Sexually-transmitted Diseases in Underdeveloped Countries 277 7. Business Trends in the Point of Care Sector 279 7.1 Sector Consolidation 279 7.2 Diagnostic Testing Growth Trends 280 7.3 Acquisition, License Agreements, Internal Development and Partnerships 281 7.4 Product Testing Depth in POCT 284 7.5 Government Regulation 284 7.5.1 U.S. Regulation 285 7.5.1.1 Importing Medical Devices into the U.S. 286 7.5.1.2 Exporting Medical Devices from the U.S. 287 7.5.2 U.K. Regulation 287 7.5.3 E.U. Regulation 288 7.5.3.1 French Regulation 290 7.5.4 Japanese Regulation 290 7.5.5 Korean Regulation 291 7.6 Increased Market Penetration 291 7.7 Costs of doing Business in Europe 292 7.8 Drivers of European Diagnostics Testing 292 7.9 European Reimbursement Practices 292 7.10 Cost Containment in Europe 293 8. Technology Platform Innovations in POCT 296 8.1 Sensor Systems for Diagnostic Applications 296 8.2 Glucose Measurements 299 8.2.1 Continuous Glucose Monitoring Systems 301 8.3 Glucose Test Methods 303 8.4 Cholesterol Testing 304 8.5 The New Paradigm 304 8.6 Consolidated Workstations and Modularity 305 8.7 Automation and Robotics in the Clinical Laboratory 305 8.8 Laboratory Information Systems (LIS) 306 8.8.1 NOVIUS Lab 306 8.9 Biosensor Technology 306 8.10 Nanogen Third Generation Point of Care Analyzer 308 8.11 Quidel MChip 309 9. Data Management and Connectivity 310 9.1 Wireless LANs 310 9.2 Connectivity Platforms 313 9.2.1 DataLink Data Management System 313 9.2.2 RALS-Plus 314 9.2.2.1 International Technidyne Corporation HEMOCHRON Signature Elite 316 9.2.2.2 Siemens Diagnostics Rapidpoint Coag 316 9.2.2.3 Radiometer 316 9.2.2.4 HemoCue's DM Hemoglobin 316 9.2.2.5 Roche Diagnostics 316 9.2.3 BD.id 317 9.2.4 Medical Implant Communications Service (MICS) 317 9.3 Advantages of POCT Connectivity 317 9.3.1 Cost Benefit of POCT and IT Connectivity 318 9.3.2 Hospital Network Issues 318 10. Corporate Profiles 319 10.1 Abaxis, Inc. 319 10.2 Abbott Laboratories 322 10.3 Accumetrics, Inc. 324 10.4 AccuTech, LLC 324 10.5 ACON Laboratories 324 10.6 Acrongenomics 324 10.7 Aerscher Diagnostics 325 10.8 Akers Biosciences, Inc. 325 10.9 Alere 325 10.10 Alfa Scientific Designs, Inc. 328 10.11 American Bio Medica Corporation 328 10.12 Amic AB 329 10.13 Ani Biotech Oy Ltd. 329 10.14 Arkray, Inc. 330 10.15 Atonomics A/S 330 10.16 Audit Diagnostics 330 10.17 Augurix Diagnostics Ltd. 330 10.18 Axis-Shield 330 10.19 Bayer 331 10.20 Beckman Coulter 331 10.21 BioLytical Laboratories 333 10.22 Biomerica, Inc. 333 10.23 BiOracle 334 10.24 Bio-Rad Laboratories, Inc. 334 10.25 BioScan Screening Systems, Inc. 335 10.26 BioSite 335 10.27 Calmark Sweden AB 335 10.28 Calypte Biomedical Corporation 335 10.29 Chembio Diagnostic Systems 336 10.30 Chempaq A/S 336 10.31 Cholestech 336 10.32 Claros Diagnostics 336 10.33 Concateno Plc 336 10.34 Dexcom 337 10.35 Enigma Diagnostics Ltd. 337 10.36 Epinex Diagnostics 337 10.37 Eurotrol 338 10.38 Exalenz Bioscience 338 10.39 GenBio 338 10.40 Genzyme 338 10.41 Helena Laboratories 339 10.42 HemoCue AB 339 10.43 HemoSense 339 10.44 Home Diagnostics (Nipro Diagnostics) 339 10.45 IND Diagnostic 339 10.46 Instrumentation Laboratory Company 339 10.47 Jant Pharmacal Corporation 340 10.48 Johnson & Johnson 340 10.49 Lein Applied Diagnostics 341 10.50 LifeAssays AB 341 10.51 LifeSign 341 10.52 Mediwatch 341 10.53 Medix Biochemica 341 10.54 MedMira 341 10.55 MELA Sciences (formerly Electro-Optical Sciences) 342 10.56 Meretek Diagnostics Group 342 10.57 Meridian Bioscience 342 10.58 Micronics 343 10.59 3M 343 10.60 New Horizons Diagnostics 343 10.61 OraSure Technologies 343 10.62 Orion Diagnostica 344 10.63 Polymer Technology Systems 344 10.64 Prima Biomedical Company 344 10.65 QBC Diagnostics 345 10.66 Qualigen 345 10.67 Quidel 345 10.68 Radiometer Medical 348 10.69 Response Biomedical 348 10.70 SA Scientific 348 10.71 Siemens AG 349 10.72 Stanbio Laboratory 349 11. POCT Sector Trends and Forecasts 351 11.1 Home Care Analysis as Part of Near-Patient Testing 351 11.2 Non-Traditional Collection for POCT 351 11.3 New Systems for Critical Care and Near-Patient Testing 351 11.4 Utility of Near-Patient Testing in Critical Care Settings 352 11.5 Physician's Office Market 352 11.6 Information Management Advances 353 11.7 Test-Ordering Patterns and Demand for POCT 353 11.8 Demand for Emergency Department Services 353 11.9 Move Away from Central Laboratory 354 11.10 Healthcare Cost Controls 355 11.11 M&A in POCT 355 11.12 Competition for Services 356 11.13 Drivers of POCT 356 11.14 Confluence of New Technology 357 11.15 Difficulties of Design for Point of Care Products 357 11.16 European Hospital Structure 357 11.17 The Biggest New Opportunities in POCT 357 12. Corporate Directory 358 INDEX OF FIGURES Figure 3.1: Blood Tests Ordered in Emergency Department Visits 26 Figure 3.2: Worldwide Distribution of IVD Testing, 2010 30 Figure 3.3: Global Point of Care Revenues, 2005-2012 32 Figure 3.4: Global Growth of Point of Care Testing Volume, 2000-2008 32 Figure 3.5: Global POCT Share of Total IVD Testing Market, 2010 34 Figure 4.1: Number of HbA1c Tests Performed Globally as POCT, 1991-2006 93 Figure 4.2: Percentage of Visits for Influenza-like Illness (ILI) Reported by the U.S. Outpatient Influenza-like Illness Surveillance Network (ILINet) and Weekly National Summary, September 30, 2007-February 12, 2011 145 Figure 4.3: Influenza Positive Tests Reported to CDC by U.S. WHO/NREVSS Collaborating Laboratories, National Summary, 2010-2011 146 Figure 5.1: Global POCT Share of HIV Testing Market, 2008 230 Figure 6.1: Annual Rate of Emergency Room Visits by Primary Expected Source of Payment 270 INDEX OF TABLES Table 2.1: Percentage of POCT Performed in Selected Hospitals 21 Table 2.2: POCT Procedural Advantages for Hospital Testing 23 Table 2.3: POCT Trends 24 Table 2.4: Professional POCT Compared to Home Testing 24 Table 2.5: Drivers for Integrating POCT into Hospital Routines 24 Table 3.1: Actual Reported Number of ER Visits in U.S. Hospitals, 1997-2010 25 Table 3.2: Number of Point of Care Tests in the U.S., 2000-2012 26 Table 3.3: Global Clinical Laboratory Market Sales, 1998-2011 28 Table 3.4: Overall IVD Testing Market Worldwide, 2010 29 Table 3.5: Worldwide Distribution of IVD Testing, 2010 29 Table 3.6: Top 12 Country IVD Testing Markets, 2010 30 Table 3.7: Global Point of Care Revenues, 2005-2012 31 Table 3.8: Worldwide POCT Market Size by Geographic Location, 2005-2012 33 Table 3.9: Worldwide Distribution of POCT, 2010 33 Table 3.10: Worldwide Clinical Diagnostic POCT and Rapid Test Market Segments, 2010 33 Table 3.11: Worldwide POCT by Performance Location, 2010 34 Table 3.12: Largest POCT Diagnostic Companies Worldwide, 2010 34 Table 3.13: U.S. Clinical Laboratory Testing Market, 2003-2012 35 Table 3.14: U.S. Clinical Laboratory Diagnostic Test Market Segments by Location of Analysis, 2010 35 Table 3.15: U.S. POCT Market, 2000-2012 36 Table 3.16: U.S. POCT by Performance Location, 2010 36 Table 3.17: U.S. Clinical Diagnostic POCT and Rapid Test Market Segments, 2010 36 Table 3.18: European Clinical Laboratory Testing IVD Reagents and Instruments Market in Dollars, 2000-2012 37 Table 3.19: European Clinical Laboratory Testing IVD Reagents and Instruments Market in Euros, 2000-2012 37 Table 3.20: European Clinical Laboratory Testing Diagnostics by Country Market Estimates, 2010 38 Table 3.21: European Rapid POCT by Country Market Estimates, 2010 39 Table 3.22: Regional Comparison of Healthcare Spending for IVD for Eastern Europe 42 Table 3.23: European POCT Market, 2005-2012 42 Table 3.24: Top 12 POCT Country Markets, 2010 42 Table 3.25: German Clinical Laboratory Testing Diagnostics Products Market Sales, 2003-2012 43 Table 3.26: German POCT Diagnostics Products Market Sales, 2003-2012 43 Table 3.27: German Clinical Diagnostic Rapid Test Market Segments, 2010 44 Table 3.28: U.K. Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 45 Table 3.29: U.K. POCT Diagnostics Products Market Sales, 2006-2012 46 Table 3.30: U.K. Clinical Diagnostic Rapid Test Market Segments, 2010 46 Table 3.31: Major U.K. IVD Manufacturers 47 Table 3.32: U.S. IVD Manufacturers Doing Business in the U.K. 47 Table 3.33: Other European Companies that Manufacture IVD Products in the U.K. 47 Table 3.34: French Clinical IVD Testing Diagnostics Products Market Sales, 2003-2012 48 Table 3.35: French POCT Diagnostics Products Market Sales, 2005-2012 49 Table 3.36: French Clinical Diagnostic Rapid Test Market Segments, 2010 49 Table 3.37: Italian Laboratory Diagnostics Products Market Sales, 2003-2012 50 Table 3.38: Italian POCT Diagnostics Products Market Sales, 2005-2012 50 Table 3.39: Italian Clinical Diagnostic Rapid Test Market Segments, 2010 50 Table 3.40: Spanish Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 51 Table 3.41: Spanish Clinical Diagnostic Rapid Test Market Segments, 2010 52 Table 3.42: Spanish POCT Diagnostics Products Market Sales, 2005-2012 52 Table 3.43: Scandinavian POCT Diagnostics Products Market Sales, 2000-2012 53 Table 3.44: Swedish Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 53 Table 3.45: Swedish POCT Diagnostics Products Market Sales, 2005-2012 54 Table 3.46: Finnish Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 54 Table 3.47: Finnish POCT Diagnostics Products Market Sales, 2005-2012 55 Table 3.48: Norwegian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 55 Table 3.49: Norwegian POCT Diagnostics Products Market Sales, 2005-2012 56 Table 3.50: Swiss Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 56 Table 3.51: Swiss POCT Diagnostics Products Market Sales, 2005-2012 57 Table 3.52: Dutch Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 57 Table 3.53: Dutch POCT Diagnostics Products Market Sales, 2005-2012 58 Table 3.54: Belgian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 58 Table 3.55: Belgian POCT Diagnostics Products Market Sales, 2005-2012 59 Table 3.56: Portuguese Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 59 Table 3.57: Portuguese POCT Diagnostics Products Market Sales, 2005-2012 60 Table 3.58: Austrian Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 60 Table 3.59: Austrian POCT Diagnostics Products Market Sales, 2005-2012 61 Table 3.60: Greek Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 61 Table 3.61: Greek POCT Diagnostics Products Market Sales, 2005-2012 62 Table 3.62: Polish Clinical Laboratory Diagnostics Products Market Sales, 2003-2012 62 Table 3.63: Polish POCT Diagnostics Products Market Sales, 2005-2012 63 Table 3.64: Czech Clinical Laboratory Diagnostics Products Market Sales, 2004-2012 63 Table 3.65: Czech POCT Diagnostics Products Market Sales, 2005-2012 64 Table 3.66: Turkish POCT Market, 2000-2012 64 Table 3.67: Japanese POCT Market, 2000-2012 65 Table 3.68: Japanese Population and Aging Demographics Forecast, 2000-2050 65 Table 3.69: Indian IVD Market for Instruments and Reagents, 2004-2012 66 Table 3.70: Number of Automated Clinical Labs in India, 2004-2012 67 Table 3.71: Indian IVD Market, 2010 67 Table 3.72: Indian POCT Diagnostics Products Market Sales, 2000-2012 71 Table 3.73: Chinese IVD Market, 2006-2012 72 Table 3.74: Number of Automated Clinical Labs in China, 2004-2012 73 Table 3.75: Chinese IVD Market, 2010 73 Table 3.76: Chinese POCT Diagnostics Products Market Sales, 2000-2012 79 Table 3.77: Rest of the World POCT Market, 2000-2012 81 Table 3.78: Canadian POCT Market, 2000-2012 82 Table 3.79: Brazilian POCT Market, 2000-2012 82 Table 3.80: Australian POCT Market, 2000-2012 83 Table 4.1: World Market Share of Point of Care Glucose Monitoring Marketers 88 Table 4.2: Global Population of Persons with Diabetes, 1995 and 2025 89 Table 4.3: Professional Glucose Testing Market for POCT Worldwide Revenue and Forecasts, 2001-2012 90 Table 4.4: U.S. Point of Care Glucose Testing Market, 1997-2012 90 Table 4.5: Rapid Testing U.S. Market Share for Blood Glucose Testing Segment 92 Table 4.6: HbA1c Testing Market for POCT Worldwide, 2006-2012 93 Table 4.7: Point of Care Glucose Testing Market: Market Drivers Ranked in Order of Impact 94 Table 4.8: Point of Care Glucose Testing Market: Market Restraints Ranked in Order of Impact 94 Table 4.9: SWOT Analysis: Summary of Strengths, Weaknesses, Opportunities and Threats of the Glucose Point of Care Market 96 Table 4.10: Critical Care Blood Gas Testing Market for POCT Worldwide, 2006-2012 97 Table 4.11: Blood Gas and Electrolyte Market for POCT in the U.S., 2001-2012 97 Table 4.12: Location Market Share of Critical Care Blood Gas Testing, 1990 and 2010 97 Table 4.13: Manufacturer Market Share U.S. POCT Blood Gas and Electrolytes Market, 2010 99 Table 4.14: Hospital Locations of Point of Care Coagulation Testing 100 Table 4.15: Drivers for Point of Care Coagulation Testing 101 Table 4.16: Barriers for Point of Care Coagulation Testing 101 Table 4.17: Coagulation Testing Market for POCT Worldwide, 2006-2012 102 Table 4.18: Handheld Coagulation Testing Market for POCT Worldwide, 2006-2012 102 Table 4.19: Coagulation Market for POCT in the U.S., 2001-2015 103 Table 4.20: Point of Care Prothrombin Market for POCT in the U.S., 2000-2010 104 Table 4.21: SWOT Analysis: Summary of Strengths, Weaknesses, Opportunities and Threats of the Coagulation Point of Care Market 108 Table 4.22: Cardiac Marker Market for POCT in the U.S., 2001-2016 110 Table 4.23: Cardiac Marker Market for POCT Worldwide, 2001-2016 111 Table 4.24: Manufacturer Market Share U.S. POCT Cardiac Marker Market, 2010 111 Table 4.25: Cardiac Marker Market for POCT in Europe, 2008-2016 112 Table 4.26: Point of Care Cardiac Marker Testing Market: Market Drivers Ranked in Order of Impact 113 Table 4.27: Point of Care Cardiac Marker Testing Market: Market Restraints Ranked in Order of Impact 113 Table 4.28: SWOT Analysis: Summary of Strengths, Weaknesses, Opportunities and Threats of the Cardiac Marker Point of Care Market 114 Table 4.29: Drugs of Abuse Testing Market for POCT Worldwide, 2006-2015 119 Table 4.30: U.S. Point of Care Drugs of Abuse Testing Market, 2006-2015 120 Table 4.31: Drug Testing Needs Tier I for Rapid Serum POCT in the Emergency Department 121 Table 4.32: Stat Urine Testing Drug Recommendations 121 Table 4.33: Device Specifications for POCT Breath Alcohol Analysis 124 Table 4.34: Global Point of Care Urine Test Strip Testing Market, 2001-2010 124 Table 4.35: Global Point of Care Urine Test Strip POCT Testing Market, 2006-2012 125 Table 4.36: U.S. Point of Care Urine Test Strip Testing Market, 2001-2011 125 Table 4.37: U.S. Point of Care Urine Test Strip Testing Market Share 125 Table 4.38: Medicare Fee Schedule for Urine Chemistry Testing, 127 Table 4.39: Pregnancy Testing Market for POCT Worldwide, 2006-2012 128 Table 4.40: U.S. Point of Care Pregnancy Testing Market, 2001-2012 128 Table 4.41: U.S. Market Share for Rapid Point of Care Pregnancy Tests 128 Table 4.42: Hemoglobin Testing Market for POCT Worldwide, 2006-2012 129 Table 4.43: Drivers of Demand for HIV Testing 134 Table 4.44: Worldwide POCT Market for HIV, 2001-2012 135 Table 4.45: U.S. POCT Market for HIV, 2001-2012 135 Table 4.46: Countries with the Highest Prevalence of HIV/AIDS 137 Table 4.47: FDA-approved Rapid HIV Antibody Screening Tests 138 Table 4.48: Cholesterol Testing Market for POCT Worldwide, 2006-2012 140 Table 4.49: Infectious Disease Testing Market for POCT Worldwide, 2006-2012 141 Table 4.50: Worldwide Point of Care Influenza Testing Market, 2002-2010 147 Table 4.51: U.S. Point of Care Influenza Testing Market, 2002-2010 147 Table 4.52: U.S. Market Share for Rapid Point of Care Influenza Tests, 2010 148 Table 4.53: Worldwide Point of Care Strep A Testing Market, 2002-2010 148 Table 4.54: U.S. Point of Care Strep A Testing Market, 2002-2010 149 Table 4.55: U.S. Market Share for Rapid Point of Care for Group A Strep Tests 149 Table 4.56: Global Market for Chlamydia Diagnostic Testing, 2000-2010 150 Table 4.57: U.S. Market for Chlamydia Diagnostic Testing, 2000-2010 150 Table 4.58: U.S. Market for MRSA Rapid Testing, 2006-2013 155 Table 4.59: Global Market for Gonorrhea Diagnostic Testing, 2000-2010 158 Table 4.60: Global Market for TB Diagnostic Testing, 2000-2010 160 Table 4.61: Point of Care Infectious Disease Testing Market: Market Drivers Ranked in Order of Impact 163 Table 4.62: Point of Care Infectious Disease Testing Market: Market Restraints Ranked in Order of Impact 163 Table 4.63: U.S. Anthrax Test Market 166 Table 5.1: Roche Diagnostics Glucose Testing Products 173 Table 5.2: Largest U.S. POCT Coagulation Diagnostic Testing Companies, 2010 189 Table 5.3: Actalyke XL 195 Table 5.4: Actalyke Mini 195 Table 5.5: Drug Test Sensitivity Cut-Off Levels Set by NIDA, WHO and SAMHSA for Drugs of Abuse 203 Table 5.6: Major Competitors in the Drugs of Abuse Oral Testing Market Segment 204 Table 5.7: Major Competitors in the Drugs of Abuse Urine Testing Market Segment 204 Table 5.8: ColoCARE Fecal Occult Blood Test 216 Table 5.9: Competitive Factors Related to HIV Tests 229 Table 5.10: Largest POCT Diagnostic Companies Worldwide, 2008 230 Table 5.11: Influenza Diagnostic Rapid Tests 244 Table 5.12: Type of Hepatitis Test: Lateral Flow 251 Table 5.13: Flow-through 252 Table 5.14: Agglutination 252 Table 5.15: Immunoblot 252 Table 5.16: AmniSure 262 Table 6.1: Access Points 265 Table 6.2: Desktop Adapters-Four Computers 265 Table 6.3: Desktop Adapters-One Computer 265 Table 6.4: PCMCIA Adapters 265 Table 6.5: POCT1-Compliant Connectivity Point of Care Instruments 268 Table 6.6: POCT Clinical Outcomes in Diabetic Ketoacidosis 270 Table 6.7: POCT Clinical Outcomes in Arterial Blood Gas Measurements 271 Table 6.8: POCT in Three Hospitals-Cost Analysis with Labor Included 273 Table 6.9: POCT versus Central Lab-Cost Analysis for Glucose Testing 274 Table 6.10: Financial Comparison for Moderate and Waived CLIA Labs 276 Table 7.1: Key Changes in IVD Business Structure 284 Table 7.2: Business Trends in POCT 293 Table 7.3: Key Players Bring Business Developments to Point of Care Diagnostic Testing 293 Table 7.4: Emerging Trends in Point of Care Testing 293 Table 7.5: Future Developments in Point of Care Testing 294 Table 7.6: The Confluence of the New Technology 294 Table 7.7: Professional Continuous Glucose Monitoring (CGM) ICD-9 Codes 294 Table 7.8: Professional CGM 295 Table 8.1: Normal Glucose Values-Fasting State 300 Table 9.1: Applications for Wireless LAN Technology 310 Table 9.2: Customized Reports Must Support CAP and JCAHO Requirements 314 Table 9.3: RALS-Plus Point of Care Market Share 315 Table 9.4: Applications of RALS Connectivity with POCT Devices 315 Table 10.1: Abaxis Blood Analysis Diagnostic Tests 320 Table 10.2: Reagent Discs Offered with the Piccolo Chemistry Analyzers 321 Table 10.3: Products Marketed by Abbott in the Diagnostic Market 323 Table 11.1: Improvements in Achieving ED Operational Efficiency Using POCT 352 Table 11.2: Test Menu and TAT for ED 353 Table 11.3: Top Reasons Why Point of Care Cardiac Marker Testing is Implemented in the ED 353 Table 11.4: Key Areas and Metrics that Hospitals Measure to Assess Efficiency of ED 354 Table 11.5: Estimates of Patient Costs by DRG 355

Companies Mentioned

- Abaxis, Inc. - Abbott Laboratories - Accumetrics, Inc. - AccuTech, LLC - ACON Laboratories - Acrongenomics - Aerscher Diagnostics - Akers Biosciences, Inc. - Alere - Alfa Scientific Designs, Inc. - American Bio Medica Corporation - Amic AB - Ani Biotech Oy Ltd. - Arkray, Inc. - Atonomics A/S - Audit Diagnostics - Augurix Diagnostics Ltd. - Axis-Shield - Bayer - Beckman Coulter - BioLytical Laboratories - Biomerica, Inc. - BiOracle - Bio-Rad Laboratories, Inc. - BioScan Screening Systems, Inc. - BioSite - Calmark Sweden AB - Calypte Biomedical Corporation - Chembio Diagnostic Systems - Chempaq A/S - Cholestech - Claros Diagnostics - Concateno Plc - Dexcom - Enigma Diagnostics Ltd. - Epinex Diagnostics - Eurotrol - Exalenz Bioscience - GenBio - Genzyme - Helena Laboratories - HemoCue AB - HemoSense - Home Diagnostics (Nipro Diagnostics) - IND Diagnostic - Instrumentation Laboratory Company - Jant Pharmacal Corporation - Johnson & Johnson - Lein Applied Diagnostics - LifeAssays AB - LifeSign - Mediwatch - Medix Biochemica - MedMira - MELA Sciences (formerly Electro-Optical Sciences) - Meretek Diagnostics Group - Meridian Bioscience - Micronics - New Horizons Diagnostics - OraSure Technologies - Orion Diagnostica - Polymer Technology Systems - Prima Biomedical Company - QBC Diagnostics - Qualigen - Quidel - Radiometer Medical - Response Biomedical - SA Scientific - Siemens AG - Stanbio Laboratory