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Point of Care Diagnostic Testing World Markets
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Point of care testing (POCT) enables rapid diagnostic tests to be performed while the patient is at the point of care facility where results can be obtained immediately, rather than waiting hours or e.....
Point of care testing (POCT) enables rapid diagnostic tests to be performed while the patient is at the point of care facility where results can be obtained immediately, rather than waiting hours or even days for outside lab results to arrive. Point of care testing covers: blood glucose testing, blood gas and electrolytes analysis, rapid coagulation testing, rapid cardiac markers diagnostics, drugs of abuse screening, urine strips testing, pregnancy testing, fecal occult blood analysis, food pathogens screening, hemoglobin diagnostics, infectious disease testing and cholesterol screening. This TriMark Publications report describes latest developments in the point of care testing market segment. It examines clinical instruments, devices and reagents and supplies as utilized in near-patient environments like hospital emergency rooms, critical care units, clinics and doctor's offices. The study defines the dollar volume of point of care sales and makes five year projections--both in the U.S. and worldwide--including Europe, Asia and Latin America. It also examines in detail the point of care sector for 25 individual country markets. A detailed summary of all important instruments in each clinical market is provided with emphasis on newly introduced products. Moreover, parallel areas where rapid detection is important using hand-held devices such as rapid detection of food pathogens and infectious diseases (MRSA, herpes simplex, avian flu, West Nile virus and typhoid) are discussed. Growth moderators and developing trends in point of care applications, as well as technology platform innovations and connectivity questions are examined in detail. The report surveys almost all of the companies known to be marketing, manufacturing or developing instruments and reagents for the point of care market in the U.S. and worldwide. Each company is discussed in depth, with a section on its history, product lines, business and marketing analysis, and a subjective commentary of the company's market position. Detailed tables and charts with sales forecasts and market data are also included. [Studien Infos ausblenden] |
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1. Overview 18 1.1 About This Report 18 1.2 Scope of the Report 20 1.3 Objectives 20 1.4 Methodology 20 1.5 Executive Summary 21 2. Overview of Diagnostic Testing Point of Care 27 2.1 Key Issues in the Point of Care Diagnostic Testing Sector 27 2.1.1 Current Market Trends and Drivers 27 2.1.2 Effectiveness of POCT 29 2.1.3 New Growth Areas for POCT 29 2.1.4 Advantages of POCT in a Clinical Setting 29 2.1.5 Pricing and Reimbursement Issues 30 2.1.6 Key Customer Segments 30 2.2 Global Point of Care Marketplace 30 2.3 Shifts from Central Lab Testing to POCT 32 2.4 Geographical Distribution 32 2.5 Challenges of POCT 35 2.6 Key Issues for POCT 36 2.6.1 Locations of POCT 36 2.6.2 Milestones in Technology Development 38 2.6.3 Drive for Decentralization from Lab to Patient 39 2.6.4 Competitive Landscape for POCT 39 2.7 The Future of POCT 40 3. Summary Analysis of the Global POCT Market: Value, Growth Rates and Market Share 42 3.1 Global POCT Market 42 4. Analysis of the U.S. POCT Market: Value, Growth Rates and Market Share 54 5. Analysis of the European POCT Market: Value, Growth Rates and Market Shares 63 6. Analysis of the POCT Markets for Japan, China and India: Value, Growth Rates and Market Share 84 6.1 Summary Analysis of the Japanese POCT Market 90 6.2 Summary Analysis of the Indian POCT Market 92 6.3 Summary Analysis of the Chinese POCT Market 95 7. Analysis of the Rest of World (ROW) POCT Market: Value, Growth Rates and Market Share 105 7.1 Summary Analysis of the ROW POCT Market Revenues 105 7.1.1 Summary Analysis of the Argentinian POCT Market 111 7.1.2 Summary Analysis of the Australian POCT Market 112 7.1.3 Summary Analysis of the Brazilian POCT Market 112 7.1.4 Summary Analysis of the Canadian POCT Market 113 7.1.5 Summary Analysis of the Russian POCT Market 113 7.1.6 Summary Analysis of the Middle East POCT Market 114 7.1.7 Summary Analysis of the African POCT Market 115 7.1.8 Summary Analysis of the Asia (Other) POCT Market 116 7.1.9 Summary Analysis of the Latin America (Other) POCT Market 119 8. Review of the Market Segments, Reagents and Equipment 121 8.1 Blood Glucose Monitoring 121 8.1.1 Introduction to Blood Glucose Monitoring 121 8.1.2 Types of Blood Glucose Testing 122 8.1.2.1 Fasting Blood Sugar (FBS) or Fasting Plasma Glucose (FPG) 122 8.1.2.2 Two-Hour Postprandial Blood Sugar or Two-Hour PC 122 8.1.2.3 Random Blood Sugar (RBS) 122 8.1.2.4 Glucose Urine Test 122 8.1.2.5 Blood Glucose Test Strip 122 8.1.2.6 Glycosylated Hemoglobin (HbA1C) 123 8.1.2.7 Intravenous Glucose Tolerance Test (IVGTT) 123 8.1.2.8 Oral Glucose Tolerance Test (OGTT) 123 8.1.3 Segmentation of POC Blood Glucose Testing 123 8.1.3.1 Continuous Blood Glucose Monitoring (CBGM) 123 8.1.3.2 Self-Monitoring Blood Glucose (SMBG) Testing 124 8.1.3.3 Minimally-Invasive and Non-Invasive Blood Glucose Testing 124 8.1.3.4 Emerging Glucose Monitoring Technologies 125 8.1.3.5 Optical Transducer Technologies 125 8.1.3.6 Transdermal Sensor Technologies 126 8.1.3.7 Invasive Glucose Sensor Technologies 128 8.1.4 Review of Selected POC Blood Glucose Monitoring Systems 128 8.1.5 Review of Company Products 132 8.1.5.1 LifeScan 132 8.1.5.2 Roche Accu-Chek 135 8.1.5.3 Abbott Diabetes Care 137 8.1.5.4 HemoCue 138 8.1.5.5 Stanbio/GDS Technology 138 8.1.5.6 Abaxis, Inc. 139 8.1.5.7 Arkray (Japan) 140 8.1.5.8 Accurex (India) 140 8.1.5.9 Home Diagnostics, Inc. 140 8.1.5.10 Nova Biomedical 140 8.1.5.11 Bayer 141 8.1.5.11.1 Hemoglobin A1c Measurements 142 8.1.5.12 AgaMatrix 143 8.1.5.13 Akray 143 8.1.5.14 EKF Diagnostics 143 8.1.5.15 ACON 143 8.1.5.16 Biosite (Now Part of Alere) 144 8.1.5.17 Siemens Healthcare Diagnostics 144 8.1.5.18 Infopia 144 8.1.5.19 Diasys 144 8.1.5.20 Quotient Dx 144 8.1.5.21 Cholestech (Acquired by Inverness Medical Innovations, Now Named Alere) 144 8.1.5.22 Bio-Rad 145 8.1.5.23 Axis-Shield 145 8.1.5.24 Abaxis, Inc. 145 8.1.6 Market Share for Glucose Testing 145 8.1.7 Competitive Analysis for the Glucose Point of Care Testing Sector 146 8.1.8 Market Analysis 147 8.1.8.1 Market Drivers 147 8.1.8.2 Market Restraints 147 8.1.9 POC Glucose Testing Assay Market and Technology Trends 147 8.1.9.1 POC Glucose Testing Assay Market Trends 147 8.1.9.2 POC Glucose Testing Assay Technology Trends 148 8.1.9.3 POC Glucose Testing Assay Strategic Recommendations 148 8.2 Blood Gas and Electrolytes 149 8.2.1 Background to POC Blood Gas and Electrolyte Testing 149 8.2.1.1 Acid-Base Balance and the Lungs 151 8.2.1.2 Respiratory Acidosis 151 8.2.1.3 Respiratory Alkalosis 151 8.2.1.4 Metabolic (or Non-Respiratory) Acidosis 151 8.2.1.5 Metabolic (or Non-Respiratory) Alkalosis 151 8.2.1.6 Increasing Popularity of POC Blood Gas and Electrolyte Testing 152 8.2.2 Market Segmentation (Segmentation by Type of Blood Gas Monitoring Equipment) 152 8.2.2.1 Intermittent Blood Gas Monitoring Equipment 152 8.2.2.2 Continuous Blood Gas Monitoring Equipment 152 8.2.2.3 Extra-Arterial Blood Gas (EABG) Monitors 153 8.2.2.4 Intra-Arterial Blood Gas (IABG) Monitors 153 8.2.2.5 Portable Blood Gas Analyzers 153 8.2.2.6 Patient-Attached On-Demand Blood Gas Analyzers 153 8.2.3 Applications for POCT Blood Gas and Electrolyte Analyzers 154 8.2.4 Emerging Technologies 154 8.2.5 Whole-Blood Lactate 154 8.2.6 Creatinine 154 8.2.7 Review of Selected Blood Gas and Electrolyte Analyzers 155 8.2.8 Review of Company Products 157 8.2.8.1 Roche Corporation 157 8.2.8.2 TechnoMedica 157 8.2.8.3 Siemens Healthcare Diagnostics 157 8.2.8.4 Instrumentation Laboratory 158 8.2.8.5 Nova Biomedical 158 8.2.8.6 Radiometer 159 8.2.8.7 Abbott Point of Care 159 8.2.8.8 Span Diagnostics 160 8.2.8.9 Nexus Dx AVOXimeter Systems for CO-oximetry 160 8.2.8.10 ITC (Nexus Dx) 161 8.2.8.11 Alere 161 8.2.8.12 Abaxis, Inc. 162 8.2.8.13 Opti Medical 162 8.2.8.14 Arkray USA 162 8.2.9 Market Share for Blood Gas and Electrolyte Testing 163 8.2.10 Competitive Analysis for the Blood Gas and Electrolyte Point of Care Testing Sector 163 8.2.11 Market Analysis 164 8.2.11.1 Market Drivers 164 8.2.11.2 Market Restraints 165 8.2.12 POC Blood Gas and Electrolyte Testing Assay Market and Technology Trends 166 8.2.12.1 POC Blood Gas and Electrolyte Testing Assay Market Trends 166 8.2.12.2 POC Blood Gas and Electrolyte Testing Assay Technology Trends 166 8.2.12.3 POC Blood Gas and Electrolyte Testing Assay Strategic Recommendations 166 8.3 Rapid Coagulation Tests 167 8.3.1 Background to Rapid Coagulation Tests 167 8.3.2 Review of Selected POC Rapid Coagulation Analyzers 173 8.3.3 Review of Company Products 175 8.3.3.1 Roche Diagnostics Corp. 175 8.3.3.2 Abbott Laboratories 177 8.3.3.3 International Technidyne Corporation Nexus DX 177 8.3.3.4 Medtronic 179 8.3.3.5 Alere HemoSense 179 8.3.3.6 Helena Laboratories Point of Care 180 8.3.3.7 Sienco, Inc. 182 8.3.3.8 Accumetrics 182 8.3.3.9 Alere 182 8.3.3.10 ITC 183 8.3.3.11 Instrumentation Laboratory�s GEM PCL Plus 183 8.3.3.12 Others 183 8.3.3.13 Self-Monitoring Products 183 8.3.3.14 Platelet Function and Antiplatelet Drug Assessment 183 8.3.4 Connectivity Issues 184 8.3.5 Cost Benefits 185 8.3.6 Quality Control Issues 185 8.3.7 Certification for POC Coagulation Devices 186 8.3.8 D-Dimer Testing 186 8.3.9 Market Analysis 187 8.3.9.1 Market Share for POCT Coagulation Testing 187 8.3.9.2 Competitive Analysis of Sector Companies 187 8.3.9.3 Market Drivers 188 8.3.9.4 Market Restraints 188 8.3.9.5 POC Coagulation Testing Assay Market Trends 189 8.3.9.6 POC Coagulation Testing Assay Technology Trends 189 8.3.9.7 POC Coagulation Testing Assay Strategic Recommendations 189 8.3.9.8 SWOT Analysis: Summary of Strengths, Weaknesses, Opportunities and Threats in the Coagulation POC Market 190 8.4 POC Rapid Cardiac Markers 190 8.4.1 Background to POC Rapid Cardiac Marker Testing 191 8.4.2 Cardiac Marker Tests 192 8.4.2.1 Creatine Kinase (CK) 192 8.4.2.2 Myoglobin 192 8.4.2.3 Cardiac Troponins T (TnT), I (TnI) and C (TnC) 193 8.4.2.4 C-Reactive Protein (CRP) 193 8.4.2.5 Homocysteine 193 8.4.3 Emerging Markers 194 8.4.3.1 B-type Natriuretic Peptide (BNP) 194 8.4.3.2 Myeloperoxidase (MPO) 194 8.4.3.3 Ischemia-Modified Albumin (IMA) 194 8.4.3.4 Glycogen Phosphorylase Isoenzyme BB (GPBB) 195 8.4.3.5 Fatty Acid-Binding Proteins (FABPs) 195 8.4.4 Review of Selected POC Cardiac Biomarkers Analyzers 195 8.4.5 Review of Company Products 197 8.4.5.1 Alere Triage Cardiac Panel 197 8.4.5.2 Roche Diagnostics 198 8.4.5.3 Ani Biotech 199 8.4.5.4 Response Biomedical Corporation 199 8.4.5.5 Siemens Healthcare Diagnostics (f/k/a Bayer Healthcare Diagnostics, Diagnostic Products Corporation and Dade Behring) 200 8.4.5.6 Lab21 Ltd. 201 8.4.5.7 Abbott Laboratories 201 8.4.5.8 LifeSign (Princeton BioMediTech Corp.) 201 8.4.5.9 Mitsubishi Kagaku Iatron 201 8.4.5.10 Alpha Scientific 201 8.4.5.11 bioM�rieux 202 8.4.5.12 Nexus 202 8.4.5.13 Princeton BioMeditech 202 8.4.5.14 Randox Laboratories 202 8.4.5.15 Market Share for Cardiac Marker Testing 203 8.4.6 Market Analysis 203 8.4.6.1 Market Drivers 203 8.4.6.2 Market Restraints 205 8.4.7 POC Cardiac Marker Testing Assay Market and Technology Trends 206 8.4.7.1 POC Cardiac Marker Testing Assay Market Trends 206 8.4.7.2 POC Cardiac Marker Testing Assay Technology Trends 206 8.4.7.3 POC Cardiac Marker Testing Assay Strategic Recommendations 207 8.5 POC Substance Abuse Testing 208 8.5.1 Background to POC Substance Abuse Testing 208 8.5.2 Substance Abuse Test Types 214 8.5.2.1 Urine Substance/Drug Screening 215 8.5.2.2 Hair Tests for Substance Abuse and Screening 215 8.5.2.3 Blood Tests for Substance Abuse and Screening 215 8.5.2.4 Saliva Tests for Substance Abuse and Screening 215 8.5.2.5 Sweat Tests for Substance Abuse and Screening 216 8.5.3 Alcohol Abuse and Screening 216 8.5.4 Saliva Testing 216 8.5.5 Qualitative Analysis 217 8.5.5.1 Market Drivers 217 8.5.5.2 Market Restraints 217 8.5.6 Review of Selected POC Substance Abuse Analyzers 218 8.5.7 Review of Company Products 219 8.5.7.1 Alere 219 8.5.7.2 Abbott Diagnostics 220 8.5.7.3 Roche Diagnostics 220 8.5.7.4 BioScan Screening Systems, Inc. 221 8.5.7.5 American Bio Medica Corp. 222 8.5.7.6 Phamatech, Inc. 225 8.5.7.7 First Check Medical 225 8.5.7.8 OraSure 226 8.5.7.9 Avitar, Inc. 226 8.5.7.10 Concateno 226 8.5.7.11 Pathtech 226 8.5.7.12 Alfa Scientific Designs, Inc. 227 8.5.7.13 TCPI, Inc. 228 8.5.7.14 Roche 228 8.5.7.15 Biophor Diagnostics 228 8.5.7.16 Randox Laboratories 228 8.5.7.17 Branan Medical 229 8.5.7.18 Concateno 229 8.6 POC Pregnancy and Fertility Tests 230 8.6.1 Background to POC Pregnancy and Fertility Tests 230 8.6.2 Review of Selected POC Pregnancy Testing Devices 230 8.6.3 Review of Company Products 232 8.6.3.1 Quidel 232 8.6.3.2 Abbott Diagnostics 232 8.6.3.3 Alere 232 8.6.3.4 Worldwide Medical Corporation 233 8.6.3.5 Genzyme Diagnostics 233 8.6.3.6 Siemens Diagnostics 233 8.6.3.7 Orgenics 233 8.6.3.8 LifeSign 233 8.6.3.9 Stanbio 234 8.6.3.10 Market Analysis 234 8.6.3.10.1 Competitive Sector Analysis 234 8.7 Fecal Occult Blood 234 8.7.1 Background to POC Fecal Occult Blood Testing 235 8.7.2 Review of Selected POC Fecal Occult Testing Devices 237 8.7.3 Review of Company Products 239 8.7.3.1 Helena Laboratories 239 8.7.3.2 Biomerica 239 8.7.3.3 Beckman Coulter 239 8.7.3.4 Worldwide Medical 239 8.7.3.5 Aerscher Diagnostics 240 8.7.3.6 Enterix 240 8.7.3.7 Medix Biochemica 240 8.7.3.8 Orion Diagnostica 240 8.7.3.9 ACON Laboratories�s Mission FOB Reagent Strips 240 8.7.3.10 Alere�s Products 241 8.7.3.11 Immunostics�s Hema-Screen 241 8.7.3.12 Princeton BioMeditech�s BioSign iFOBTest 241 8.7.3.13 Quest Diagnostics�s InSure FIT 241 8.7.3.14 Quidel�s QuickVue iFOB 241 8.7.4 Market Share for Fecal Occult Blood Testing 241 8.7.4.1 Company Analysis for the Fecal Occult Blood Point of Care Testing Sector 241 8.7.5 Market Analysis 242 8.7.5.1 Market Drivers 242 8.7.5.2 Market Restraints 242 8.7.5.3 POC Fecal Occult Blood Testing Assay Market and Technology Trends 242 8.7.5.3.1 POC Fecal Occult Blood Testing Assay Market Trends 242 8.7.5.3.2 Fecal Occult Blood Testing Assay Technology Trends 243 8.7.5.3.3 Point of Care Fecal Occult Blood Testing Assay Strategic Recommendations 243 8.8 POC Infectious Disease Testing 244 8.8.1 Background to POC Infectious Disease Testing 244 8.8.2 Types of Diagnosis for Infectious Diseases 245 8.8.2.1 Microbial Culture 245 8.8.2.2 Microscopy 245 8.8.2.3 Biochemical Tests 246 8.8.2.4 Molecular Diagnostics 246 8.8.3 Diagnostic Platforms for Infectious Diseases 247 8.8.3.1 Centralized Laboratory Testing for Infectious Diseases 247 8.8.3.2 POC Testing for Infectious Diseases 247 8.8.4 Emerging Technologies 247 8.8.5 Qualitative Analysis 248 8.8.5.1 Market Drivers 248 8.8.5.2 Market Restraints 248 8.8.6 Review of Selected POC Infectious Disease Testing Devices 248 8.9 POC Urine Strip Testing 251 8.9.1 Background to POC Urine Strip Testing 251 8.9.2 Emerging Technologies 253 8.9.3 Review of Selected POC Urine Strip Testing 254 8.10 POC Cholesterol Testing 255 8.10.1 Background to POC Cholesterol Testing 255 8.10.2 POC Cholesterol Testing Devices 258 8.10.2.1 Review of Selected POC Cholesterol Testing Devices 258 8.10.3 Review of Company Products 259 8.10.3.1 Cholestech (now Alere) 259 8.10.3.2 Actimed Laboratories 260 8.10.3.3 StatSite Meter 260 8.10.3.4 Polymer Technology Systems 260 8.10.3.5 PreMD, Inc. (f/k/a International Medical Innovations, Inc. [IMI]) 260 8.10.3.6 Abaxis, Inc. 261 8.10.3.7 Miraculins�s PREVU Point of Care Skin Sterol Test 261 8.10.4 Product Comparison of Leading Suppliers 261 8.10.5 Launch Dates of Leading Products in Europe 263 8.11 Miscellaneous POC Tests 263 8.11.1 Triage C. difficile Panel 263 8.11.2 Ketoacids 264 8.11.3 Acetaminophen 264 8.11.4 Estriol 264 8.11.5 POC H. pylori Testing 265 8.12 POC Vaginal Fluid pH and Vaginitis Testing 269 8.13 POC Cancer Testing 269 8.13.1 Prostate-Specific Antigen (PSA) 269 8.13.2 Bladder Cancer 270 8.13.3 Other Rapid Cancer Tests 274 8.14 Fetal Status (PROM) 274 8.15 Osteoporosis 275 8.16 Hemodynamic Monitoring 275 8.17 Heparin-Induced Thrombocytopenia 276 8.18 HIV 276 8.18.1 Whole-Blood, Serum or Plasma-Based HIV Tests 279 8.18.1.1 Bio-Rad Laboratories 279 8.18.1.2 Orgenics (Inverness, Now Called Alere) 279 8.18.1.3 StatSure Diagnostic Systems 279 8.18.1.4 Trinity Biotech 279 8.18.1.5 Savyon Diagnostics 280 8.18.1.6 MedPharm 280 8.18.1.7 American Bio Medica Corp. 280 8.18.1.8 Chembio Diagnostics 280 8.18.1.9 OraSure Technologies 281 8.18.1.10 Alere 282 8.18.1.11 Hema Diagnostics Systems 282 8.18.1.12 bioLytical Laboratories�s INSTI Kit 282 8.18.1.13 bioM�rieux�s VIKIA HIV-1/2 Test 282 8.18.1.14 Chembio Diagnostics�s Dual-Path Platform Technology Products 282 8.18.1.15 Daktari Diagnostics�s Daktari CD4 283 8.18.1.16 EY Laboratories�s InstantCHEK 283 8.18.1.17 IND Diagnostic�s One-Step Anti-HIV (1+2) Test 283 8.18.1.18 IQuum�s Liat System 283 8.18.1.19 Lab21�s Biotec Tests 283 8.18.1.20 MedMira�s HIV Tests 283 8.18.1.21 YD Diagnostics�s AIDScan 283 8.18.2 Saliva-Based HIV Tests 283 8.18.2.1 OraSure Collection Device 284 8.18.2.2 SureStat 285 8.18.2.3 Calypte 285 8.18.3 Urine-Based HIV Tests 285 8.18.3.1 MedMira Laboratories, Inc. 285 8.18.3.2 Medical Services International, Inc. 286 8.18.3.3 Maxim Biomedical 286 8.18.3.4 Wampole Laboratories 287 8.19 Infectious Disease 287 8.19.1 C. difficile 287 8.19.2 Giardia 288 8.19.3 Dengue Fever 288 8.19.4 Malaria Testing 288 8.19.5 Rapid Influenza Testing 290 8.19.6 Streptococcus Testing 293 8.19.7 Chlamydia 295 8.19.8 Mononucleosis 296 8.19.9 Rubella 297 8.19.10 Staphylococcus aureus and MRSA 297 8.19.11 Hepatitis 298 8.19.12 E. coli O157 301 8.19.13 Gonorrhea Testing 301 8.19.14 Smallpox 302 8.19.15 SARS 302 8.19.16 Rabies 302 8.19.17 Tuberculosis 302 8.19.18 Avian Flu 303 8.19.19 West Nile Virus 304 8.19.20 Herpes Simplex Virus Type-2 304 8.19.21 Legionella 304 8.19.22 RSV 304 8.19.23 Leptospirosis 306 8.19.24 Sexually-Transmitted Diseases 306 8.19.25 Infant Jaundice 308 8.19.26 Anthrax 308 8.20 Homeland Defense (Plague and Tularemia) 310 8.21 BSE (Mad Cow Disease) 310 8.22 Tuberculosis 310 8.23 Typhoid 311 8.24 Avian Flu 311 8.25 Food Pathogens (Salmonella, Listeria, Campylobacter) 311 8.26 Ruptured Fetal Membranes 312 8.27 Alcohol 313 8.28 Microalbumin Testing 313 8.29 Labor and Delivery Testing 313 8.29.1 Alere Triage PLGF 313 8.29.2 Amnisure� 313 8.29.3 Medix Biochemica 314 8.30 Sperm Fertility 315 8.31 Surgical Coagulation and Hemostasis Management 315 8.32 Respiratory Tests 315 8.33 C-Reactive Protein 315 9. POCT: Growth Regulators 316 9.1 Moderators of Growth 316 9.2 Personnel Acceptance 316 9.3 Key People for POCT 317 9.4 Information Management Issues 317 9.4.1 Elements of Information Management for POCT: Information Processing Capabilities 319 9.4.2 Data Mining 319 9.4.3 Middleware 319 9.4.4 Web Portals 320 9.4.5 POCT-1A Standard 320 9.5 Key Elements for POCT 321 9.6 POCT and Reimbursement 321 9.7 Effectiveness of Clinical Outcomes 323 9.8 Rapid Near-Patient Testing in Hospitals 324 9.9 Satellite Facilities 324 9.10 Regionalization of Laboratory Care 325 9.11 Requirements for POCT 326 9.12 Locations of Point of Care for Patient Care 327 9.13 Benefits of POCT 328 9.14 Cost Elements of POCT 329 9.15 Necessary Functions in POCT 329 9.16 Turnaround Time (TAT) for POCT 329 9.17 Clinical Laboratory Improvement Amendments (CLIA) 330 9.18 Sexually-Transmitted Diseases in Underdeveloped Countries 332 9.19 Sources of Error in POC Testing 332 10. Business Trends in the POC Sector 335 10.1 Sector Consolidation 335 10.2 Diagnostic Testing Growth Trends 336 10.2.1 Opportunities for Healthcare Stakeholders 337 10.3 Acquisition, License Agreements, Internal Development and Partnerships 337 10.4 Product Testing Depth in POCT 341 10.5 Government Regulation 341 10.5.1 U.S. Regulation 341 10.5.1.1 Importing Medical Devices into the U.S. 342 10.5.1.2 Exporting Medical Devices from the U.S. 343 10.5.2 E.U. Regulation 344 10.5.3 Japanese Regulation 347 10.5.4 Korean Regulation 348 10.6 Post-Filing Regulations for POC Devices 348 10.7 Exporting Unapproved POCTs 349 10.8 Analyte-Specific Reagents (Home Brew Tests) 349 10.9 Medical Device Registration 350 10.10 Product Labeling 350 10.11 Punitive FDA Actions 350 10.12 CLIA �88 and State Laboratory Laws 351 10.13 Impact of Regulations on the Industry 351 10.14 Minimizing Regulatory Barriers 352 10.15 Waived Testing 354 11. Technology Platform Innovations in POCT 356 11.1 Latest POCT Technological Platforms 356 11.1.1 Device Miniaturization and Microfluidic Technologies 356 11.1.2 Minimally-Invasive and Non-Invasive POCT Technologies 356 11.1.3 Advances in Wireless Technologies 356 11.1.4 Automation of POCT 357 11.1.5 Developments in New Genomic Technologies (Genotyping, Haplotyping and Sequencing Technologies) 357 11.1.6 Advances in Informatics Technologies 359 11.1.7 Pharmacogenetic Testing 360 11.1.8 Multi-Assay Technologies in POCT 360 11.2 Developments in Key Technologies 360 11.2.1 Medical and Biological Sensors and Sensor Systems 360 11.2.2 Recent Biosensor Product Introductions and Latest Innovative Developments 361 11.2.2.1 Nanoscale Sensors for the Detection of Cancer Biomarkers 361 11.2.2.2 ForteBio Introduces Dip and Read Protein G Biosensor for Octet Instruments 362 11.2.2.3 ForteBio Launches New Octet RED96 System and Dip and Read Protein L Biosensor 362 11.2.2.4 AgaMatrix Europe Limited Introduces the New Jazz� Blood Glucose Meter in the U.K. 362 11.2.2.5 STMicroelectronics to Manufacture the World�s Smallest Biosensors 363 11.2.2.6 Universal Biosensors Advances POC Molecular Diagnostic Opportunity 363 11.2.2.7 Clinitek Advantus�A Semi-Automated Urine Analyzer for POC Testing 363 11.2.2.8 NOVA 16 STAT Chemistry Analyzer Offers the First All-Electrode-Based Seven-Test Chemistry Profile 363 11.3 Sensor Systems for Diagnostic Applications 364 11.4 Nanogen (The ELITech Group) Third-Generation POC Analyzer 367 11.5 Philips Development of Magnotech Technology 367 11.6 Quidel Corporation MChip, AVR Chip and F Chip 367 11.7 Sanofi-Aventis 368 12. Data Management and Connectivity 370 12.1 Wireless LANs 370 12.2 Connectivity Platforms 372 12.2.1 DataLink Data Management System 373 12.2.2 RALS-Plus 374 12.2.2.1 International Technidyne Corporation HEMOCHRON Signature Elite 375 12.2.2.2 Siemens Diagnostics Rapidpoint Coag 376 12.2.2.3 Radiometer 376 12.2.2.4 HemoCue�s DM Hemoglobin 376 12.2.2.5 Roche Diagnostics 376 12.2.3 BD.id 377 12.2.4 Medical Implant Communications Service (MICS) 377 12.2.5 Conworx Technology 377 12.2.6 Lab Data Systems 377 12.2.7 Medasys 378 12.2.8 NoemaLife 378 12.3 Advantages of POCT Connectivity 378 12.3.1 Cost-Benefit Analysis of POCT and IT Connectivity 379 12.3.2 Hospital Network Issues 379 12.4 POCT Analyzer Connectivity Software Solutions 379 12.5 POCT2-P 381 13. Corporate Profiles 382 13.1 Abaxis, Inc. 382 13.2 Abbott Laboratories 386 13.3 Accumetrics, Inc. 389 13.4 AccuTech, LLC 390 13.5 ACON Laboratories, Inc. 390 13.6 Acrongenomics 390 13.7 AgaMatrix 390 13.8 Aerscher Diagnostics 391 13.9 Akers Biosciences, Inc. 391 13.10 Alere 392 13.11 Alfa Scientific Designs, Inc. 396 13.12 American Bio Medica Corporation 397 13.13 Ani Biotech Oy Ltd. 398 13.14 Ark Therapeutics 398 13.15 Arkray, Inc. 399 13.16 Atonomics A/S 399 13.17 Audit Diagnostics 399 13.18 Augurix Diagnostics Ltd. 400 13.19 Axis-Shield 400 13.20 Axxin 400 13.21 Bayer Corp. 401 13.22 Beckman Coulter 402 13.23 BioLytical Laboratories 405 13.24 Biomerica, Inc. 405 13.25 bioM�rieux 406 13.26 BiOracle 407 13.27 Bio-Rad Laboratories, Inc. 407 13.28 BioScan Screening Systems, Inc. 408 13.29 BioSite 408 13.30 Calmark Sweden AB 408 13.31 Calypte Biomedical Corporation 408 13.32 Chembio Diagnostic, Inc 409 13.33 Chempaq A/S 410 13.34 Cholestech 410 13.35 Claros Diagnostics 410 13.36 CompuCyte Corporation 410 13.37 Concateno Plc 411 13.38 Diagnostics Chemicals Ltd. 411 13.39 Dexcom 411 13.40 Enigma Diagnostics Ltd. 411 13.41 EY Laboratoires, Inc. 412 13.42 Eurotrol 412 13.43 Exalenz Bioscience 413 13.44 GenBio 413 13.45 Genzyme Diagnostics 413 13.46 Helena Laboratories 413 13.47 Hema Diagnostic Systems, LLC 414 13.48 HemoCue AB 414 13.49 HemoSense 415 13.50 Home Diagnostics (Nipro Diagnostics) 415 13.51 IND Diagnostic 415 13.52 Instrumentation Laboratory (IL)/Werfen Group 415 13.53 International Technidyne Corporation 415 13.54 Jant Pharmacal Corporation 416 13.55 Johnson & Johnson 416 13.56 Lein Applied Diagnostics 417 13.57 LifeAssays AB 418 13.58 LifeSign, LLC 418 13.59 Medica 418 13.60 Medical Automation Systems 418 13.61 Mediwatch 418 13.62 Medix Biochemica 418 13.63 MedMira Laboratories 419 13.64 MELA Sciences (Formerly Electro-Optical Sciences) 420 13.65 A. Menarini Diagnostics 421 13.66 Meretek Diagnostics Group 421 13.67 Meridian Bioscience 422 13.68 Micronics 424 13.69 Minimed 424 13.70 Mitsubishi Chemical Holdings USA, Inc. 424 13.71 Mitsubishi Kagaku Iatron 425 13.72 Nanogen (ELITech Group) 425 13.73 New Horizons Diagnostics 425 13.74 Nexus DX/ITC 426 13.75 Nova Biomedical 426 13.76 OraSure Technologies, Inc 428 13.77 Orion Diagnostica 429 13.78 Polymedco, Inc. 430 13.79 Polymer Technology Systems, Inc. 431 13.80 Prima Biomedical Company 431 13.81 QBC Diagnostics 431 13.82 Qualigen 431 13.83 Quest Diagnostics, Inc. 432 13.84 Quidel Corporation 433 13.85 Radiometer Medical 437 13.86 Response Biomedical 440 13.87 Roche Diagnostics 441 13.88 Savyon Diagnostics 443 13.89 Selfcare, Inc. 445 13.90 Shionogi & Co., Ltd. 445 13.91 Siemens AG 445 13.92 Guided Therapeutics, Inc. (SpectRx, Inc.) 446 13.93 Spectral Diagnostics 446 13.94 StatSure Diagnostic Systems, Inc. 446 13.95 Strategic Diagnostics 447 13.96 Trinity Biotech, Plc 447 13.97 V�samed, Inc. 450 14. POCT Sector Trends and Forecasts 451 14.1 Home Care Analysis as Part of Near-Patient Testing 451 14.2 Non-Traditional Collection for POCT 451 14.3 New Systems for Critical Care and Near-Patient Testing 451 14.4 Utility of Near-Patient Testing in Critical-Care Settings 452 14.5 Physician�s Office Market 452 14.6 Information Management Advances 453 14.7 Test-Ordering Patterns and Demand for POCT 453 14.8 Demand for Emergency Department Services 453 14.9 Move Away from the Central Laboratory 454 14.10 Healthcare Cost Controls 455 14.11 Mergers and Acquisitions in POCT 455 14.12 Competition for Services 456 14.13 Drivers of POCT 456 14.14 Confluence of New Technology 456 14.15 Difficulties of Design for POC Products 457 14.16 European Hospital Structure 457 14.17 The Biggest New Opportunities in POCT 457 15. Corporate Directory 458 [Inhaltsverzeichnis ausblenden] |
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Figure 2.1: Worldwide Distribution of IVD Testing, 2011 33 Figure 2.2: Top 13 Country IVD Testing Markets, 2011 34 Figure 2.3: Company Market Share for IVD Testing Markets, 2011 35 Figure 3.1: Total Global POCT Market, 2008-2018 43 Figure 3.2: Worldwide Distribution of POCT, 2011 52 Figure 3.3: Summary of Global POCT Markets by Market Segment, 2011 53 Figure 4.1: U.S. Revenues for POCT Market, 2008-2018 54 Figure 4.2: Summary of U.S. POCT Markets by Market Segment, 2011 62 Figure 5.1: European Revenues for POCT Market, 2008-2018 70 Figure 6.1: Summary Analysis of Japanese, Chinese and Indian POCT Market, 2008-2018 84 Figure 6.2: Japanese Revenues for POCT Market, 2008-2018 92 Figure 6.3: Indian Revenues for POCT Market, 2008-2018 95 Figure 6.4: Chinese Revenues for POCT Market, 2008-2018 98 Figure 7.1: Summary Analysis of the ROW POCT Market, 2008-2018 105 Figure 7.2: Summary Analysis of the Russian Revenues for POC Testing Products Market, 2008-2018 114 Figure 7.3: Summary Analysis of the Middle East Revenues for POC Testing Products Market, 2008-2018 115 Figure 7.4: Summary Analysis of the African Revenues for POC Testing Products Market, 2008-2018 116 Figure 7.5: Summary Analysis of the Latin America (Other) Revenues for POC Testing Products Market, 2008- 2018 120 Figure 8.1: Global POCT Share of Glucose Testing Market, 2011 145 Figure 8.2: Global POCT Share of Blood Gas and Electrolyte Testing Market, 2011 163 Figure 8.3: Global POCT Share of Coagulation Testing Market, 2011 187 Figure 8.4: Global POCT Share of Cardiac Marker Testing Market, 2011 203 Figure 8.5: Global POCT Share of HIV Testing Market, 2008 278 Figure 8.6: Performance Metrics of ROM Diagnostic Methods 314 Figure 9.1: Annual Rate of Emergency Room Visits by Primary Expected Source of Payment 323 Figure 9.2: CLIA Laboratories by Certificate Types 330 Figure 10.1: Conformity Assessment Route, Annexes and Quality System Standards by IVD Device Category 345 Table 1.1: Summary of Global POCT Markets by Major Market Sub-Segment, 2011 and 2018 22 Table 1.2: Summary of U.S. POCT Markets by Major Market Sub-Segment, 2011 and 2018 22 Table 1.3: Summary of European POCT Markets by Major Market Sub-Segment, 2011 and 2018 23 Table 1.4: Summary of Asian POCT Markets by Major Market Sub-Segment, 2011 and 2018 23 Table 1.5: Summary of ROW POCT Markets by Major Market Sub-Segment, 2011 and 2018 24 Table 1.6: Worldwide POCT Market Size by Geographic Location, 2008-2018 24 Table 1.7: Global Market Share Analysis, 2011 25 Table 2.1: POCT Frequency in Hospitals 31 Table 2.2: Worldwide Distribution of IVD Testing, 2011 33 Table 2.3: Top 13 Country IVD Testing Markets, 2011 34 Table 2.4: Company Market Share for IVD Testing Markets, 2011 35 Table 2.5: Competitive Landscape for Point of Care Diagnostic Testing 39 Table 3.1: Total Global POCT Market, 2008-2018 42 Table 3.2: Global Revenues for POC Blood Glucose Monitoring Systems, 2008-2018 43 Table 3.3: Global Revenues for POC Blood Gas and Electrolyte Analyzers, 2008-2018 44 Table 3.4: Global Revenues for POC Rapid Coagulation Analyzer Systems, 2008-2018 45 Table 3.5: Global Revenues for POC Cardiac Marker Devices, 2008-2018 46 Table 3.6: Global Revenues for POC Substance/Drug Abuse Testing Device Market, 2008-2018 47 Table 3.7: Global Revenues for POC Infectious Disease Testing Devices Market, 2008-2018 47 Table 3.8: Global Revenues for POC Urine Strip Testing Products Market, 2008-2018 48 Table 3.9: Global Revenues for POC Pregnancy Testing Devices Market, 2008-2018 48 Table 3.10: Global Revenues for POC Fecal Occult Testing Devices Market, 2008-2018 49 Table 3.11: Global Revenues for POC Cholesterol Testing Products Market, 2008-2018 50 Table 3.12: Global POCT Market Share Analysis, 2011 51 Table 3.13: Worldwide POCT Market Size by Geographic Location, 2008-2018 51 Table 3.14: Worldwide Distribution of POCT, 2011 52 Table 3.15: Summary of Global POCT Markets by Market Segment, 2011 52 Table 3.16: Worldwide POCT by Performance Location, 2011 53 Table 4.1: U.S. Revenues for POCT Market, 2008-2018 54 Table 4.2: U.S Revenues for POC Blood Glucose Monitoring Systems, 2008-2018 55 Table 4.3: U.S Revenues for POC Blood Gas and Electrolyte Analyzers, 2008-2018 56 Table 4.4: U.S. Revenues for POC Rapid Coagulation Analyzer Systems, 2008-2018 56 Table 4.5: U.S. Revenues for POC Cardiac Marker Devices, 2008-2018 57 Table 4.6: U.S Manufacturer Market Share U.S. POCT Cardiac Marker Market, 2011 57 Table 4.7: U.S. Revenues for POC Substance/Drug Abuse Testing Device Market, 2008-2018 58 Table 4.8: U.S. Revenues for POC Infectious Disease Testing Devices Market, 2008-2018 58 Table 4.9: U.S. Revenues for POC Urine Strip Testing Products Market, 2008-2018 59 Table 4.10: U.S. Revenues for POC Pregnancy Testing Devices Market, 2008-2018 59 Table 4.11: U.S. Revenues for POC Fecal Occult Testing Devices Market, 2008-2018 60 Table 4.12: U.S. Revenues for POC Cholesterol Testing Products Market, 2008-2018 60 Table 4.13: U.S. POCT Market Share Analysis, 2011 61 Table 4.14: U.S. POCT by Performance Location, 2010 61 Table 4.15: Summary of U.S. POCT Markets by Market Segment, 2011 61 Table 5.1: Models of Public-Private Partnership in Hospital Provision 66 Table 5.2: European Revenues for POCT Market, 2008-2018 69 Table 5.3: French Revenues for POCT Systems, 2008-2018 70 Table 5.4: German Revenues for POCT Systems, 2008-2018 71 Table 5.5: Italian Revenues for POCT Systems, 2008-2018 71 Table 5.6: Spanish Revenues for POCT Systems, 2008-2018 72 Table 5.7: U.K. Revenues for POCT Systems, 2008-2018 72 Table 5.8: Benelux Revenues for POCT Systems, 2008-2018 73 Table 5.9: Scandinavian Revenues for POCT Systems, 2008-2018 73 Table 5.10: Rest-of-Europe Revenues for POCT Systems, 2008-2018 74 Table 5.11: European Revenues for POC Blood Glucose Monitoring Systems, 2008-2018 75 Table 5.12: European Revenues for POC Blood Gas and Electrolyte Analyzers, 2008-2018 75 Table 5.13: European Revenues for POC Rapid Coagulation Analyzer Systems, 2008-2018 76 Table 5.14: European Revenues for POC Cardiac Marker Devices, 2008-2018 78 Table 5.15: European Revenues for POC Substance/Drug Abuse Testing Device Market, 2008-2018 79 Table 5.16: European Revenues for POC Infectious Disease Testing Devices Market, 2008-2018 80 Table 5.17: European Revenues for POC Urine Strip Testing Products Market, 2008-2018 80 Table 5.18: European Revenues for POC Pregnancy Testing Devices Market, 2008-2018 81 Table 5.19: European Revenues for POC Fecal Occult Testing Devices Market, 2008-2018 82 Table 5.20: European Revenues for POC Cholesterol Testing Products Market, 2008-2018 82 Table 5.21: European Market Share Analysis, 2011 83 Table 6.1: Summary Analysis of Japanese, Chinese and Indian POCT Market, 2008-2018 84 Table 6.2: Summary Analysis of Japanese, Chinese and Indian Revenues for POC Blood Glucose Monitoring Systems, 2008-2018 85 Table 6.3: Summary Analysis of Japanese, Chinese and Indian Revenues for POC Blood Gas and Electrolyte Analyzers, 2008-2018 85 Table 6.4: Summary Analysis of Japanese, Chinese and Indian Revenues for POC Rapid Coagulation Analyzer Systems, 2008-2018 86 Table 6.5: Summary Analysis of Japanese, Chinese and Indian Revenues for POC Cardiac Marker Devices, 2008-2018 86 Table 6.6: Summary Analysis of Japanese, Chinese and Indian Revenues for POC Substance/Drug Abuse Testing Device Market, 2008-2018 87 Table 6.7: Summary Analysis of Japanese, Chinese and Indian Revenues for POC Infectious Disease Testing Devices Market, 2008-2018 87 Table 6.8: Summary Analysis of Japanese, Chinese and Indian Revenues for POC Urine Strip Testing Products Market, 2008-2018 88 Table 6.9: Summary Analysis of Japanese, Chinese and Indian Revenues for POC Pregnancy Testing Devices Market, 2008-2018 88 Table 6.10: Summary Analysis of Japanese, Chinese and Indian Revenues for POC Fecal Occult Testing Devices Market, 2008-2018 89 Table 6.11: Summary Analysis of Japanese, Chinese and Indian Revenues for POC Cholesterol Testing Products Market, 2008-2018 89 Table 6.12: Summary Analysis of Japanese, Chinese and Indian Market Shares, 2011 90 Table 6.13: Japanese Population and Aging Demographics Forecast, 2000-2050 91 Table 6.14: Japanese Revenues for POCT Market, 2008-2018 91 Table 6.15: Indian Revenues for POCT Market, 2008-2018 95 Table 6.16: Chinese Revenues for POCT Market, 2008-2018 98 Table 7.1: Summary Analysis of the ROW POCT Market, 2008-2018 105 Table 7.2: Summary Analysis of ROW Revenues for POC Blood Glucose Monitoring Systems, 2008-2018 106 Table 7.3: Summary Analysis of ROW Revenues for POC Blood Gas and Electrolyte Analyzers, 2008-2018 106 Table 7.4: Summary Analysis of ROW Revenues for POC Rapid Coagulation Analyzer Systems, 2008-2018 107 Table 7.5: Summary Analysis of ROW Revenues for POC Cardiac Marker Devices, 2008-2018 107 Table 7.6: Summary Analysis of ROW Revenues for POC Substance/Drug Abuse Testing Device Market, 2008-2018 108 Table 7.7: Summary Analysis of ROW Revenues for POC Infectious Disease Testing Devices Market, 2008-2018 108 Table 7.8: Summary Analysis of ROW Revenues for POC Urine Strip Testing Products Market, 2008-2018 109 Table 7.9: Summary Analysis of ROW Revenues for POC Pregnancy Testing Devices Market, 2008-2018 109 Table 7.10: Summary Analysis of ROW Revenues for POC Fecal Occult Testing Devices Market, 2008-2018 110 Table 7.11: Summary Analysis of ROW Revenues for POC Cholesterol Testing Products Market, 2008-2018 110 Table 7.12: Summary Analysis of ROW Market Shares, 2011 111 Table 7.13: Summary Analysis of Argentinian Revenues for POC Testing Products Market, 2008-2018 111 Table 7.14: Summary Analysis of Australian Revenues for POC Testing Products Market, 2008-2018 112 Table 7.15: Summary Analysis of Brazilian Revenues for POC Testing Products Market, 2008-2018 112 Table 7.16: Summary Analysis of Canadian Revenues for POC Testing Products Market, 2008-2018 113 Table 7.17: Summary Analysis of Russian Revenues for POC Testing Products Market, 2008-2018 113 Table 7.18: Summary Analysis of Middle East Revenues for POC Testing Products Market, 2008-2018 114 Table 7.19: Summary Analysis of African Revenues for POC Testing Products Market, 2008-2018 115 Table 7.20: Summary Analysis of Asia (Other) Revenues for POC Testing Products Market, 2008-2018 116 Table 7.21: Summary Analysis of Latin America (Other) Revenues for POC Testing Products Market, 2008-2018 119 Table 8.1: Summary of Emerging Glucose Sensor Technologies, 2011 126 Table 8.2: Selected POC Blood Glucose Monitoring Systems, 2011 129 Table 8.3: Roche Diagnostics Glucose Testing Products 137 Table 8.4: Market Share of Glucose POCT Diagnostic Testing Companies Worldwide, 2011 146 Table 8.5: SWOT Analysis: Summary of Strengths, Weaknesses, Opportunities and Threats in the Glucose POC Market 149 Table 8.6: Selected POC Blood Gas and Electrolyte Analyzers, 2011 155 Table 8.7: Market Share Blood Gas and Electrolyte POCT Diagnostic Testing Companies Worldwide, 2011 163 Table 8.8: SWOT Analysis: Summary of Strengths, Weaknesses, Opportunities and Threats in the Blood Gas and Electrolyte POC Market 167 Table 8.9: Selected POC Rapid Coagulation Analyzers, 2011 173 Table 8.10: Actalyke XL 181 Table 8.11: Actalyke Mini 181 Table 8.12: Market Share for Coagulation POCT Diagnostic Testing Companies Worldwide, 2011 187 Table 8.13: SWOT Analysis: Summary of Strengths, Weaknesses, Opportunities and Threats in the Coagulation POC Market 190 Table 8.14: Selected POC Cardiac Biomarkers, 2011 195 Table 8.15: Market Share of Cardiac Marker POCT Diagnostic Testing Companies Worldwide, 2011 203 Table 8.16: POC Cardiac Marker Testing Market: Market Drivers Ranked in Order of Impact 205 Table 8.17: POC Cardiac Marker Testing Market: Market Restraints Ranked in Order of Impact 206 Table 8.18: SWOT Analysis: Summary of Strengths, Weaknesses, Opportunities and Threats in the Cardiac Marker POC Market 207 Table 8.19: Drug Testing Needs Tier I for Rapid Serum POCT in the Emergency Department 213 Table 8.20: Stat Urine Testing Drug Recommendations 213 Table 8.21: Selected POC Substance/Drug Abuse Testing Devices, 2011 218 Table 8.22: Selected POC Pregnancy Testing Devices, 2011 231 Table 8.23: Selected POC Fecal Occult Testing Devices, 2011 237 Table 8.24: ColoCARE Fecal Occult Blood Test 239 Table 8.25: SWOT Analysis: Summary of Strengths, Weaknesses, Opportunities and Threats in the Fecal Occult Blood Point of Care Market 244 Table 8.26: Selected POC Infectious Disease Testing Devices, 2011 249 Table 8.27: Selected POC Urine Strip Testing, 2011 254 Table 8.28: Selected POC Cholesterol Testing Devices, 2011 258 Table 8.29: Competitive Factors Related to HIV Tests 277 Table 8.30: Largest POCT Diagnostic Companies Worldwide, 2008 278 Table 8.31: Influenza Diagnostic Rapid Tests 291 Table 8.32: Type of Hepatitis Test: Lateral Flow 300 Table 8.33: Flow-Through 301 Table 8.34: Agglutination 301 Table 8.35: Immunoblot 301 Table 8.36: AmniSure 313 Table 9.1: Access Points 318 Table 9.2: Desktop Adapters�Four Computers 318 Table 9.3: Desktop Adapters�One Computer 318 Table 9.4: PCMCIA Adapters 318 Table 9.5: POCT1-Compliant Connectivity Point of Care Instruments 321 Table 9.6: POCT Clinical Outcomes in Diabetic Ketoacidosis 324 Table 9.7: POCT Clinical Outcomes in Arterial Blood Gas Measurements 324 Table 9.8: POCT in Three Hospitals�Cost Analysis with Labor Included 327 Table 9.9: POCT versus Central Lab�Cost Analysis for Glucose Testing 327 Table 9.10: CLIA Laboratories by Type of Facility 328 Table 9.11: Financial Comparison for Moderate and Waived CLIA Labs 331 Table 9.12: Top Ten CMS Survey Deficiencies for CLIA Laboratories 334 Table 10.1: Key Changes in IVD Business Structure 340 Table 11.1: Common Genotype Techniques 358 Table 12.1: Applications for Wireless LAN Technology 370 Table 12.2: Customized Reports Must Support CAP and JCAHO Requirements 373 Table 12.3: RALS-Plus POC Market Share 374 Table 12.4: Applications of RALS Connectivity with POCT Devices 375 Table 13.1: Abaxis Blood Analysis Diagnostic Tests 383 Table 13.2: Reagent Discs Offered with the Piccolo Chemistry Analyzers 384 Table 13.3: Abaxis, Inc. Financial Figures�Net Sales by Business Sector, 2008-2010 385 Table 13.4: Abaxis, Inc. Financial Figures�Net Sales by Geographic Region, 2008-2010 386 Table 13.5: Products Marketed by Abbott in the Diagnostic Market 387 Table 13.6: Abbott Laboratories Financial Figures�Net Sales by Business Sector, 2008-2010 388 Table 13.7: Abbott Laboratories Financial Figures�Net Sales by Geographic Region, 2008-2010 389 Table 13.8: Alere, Inc. Financial Figures�Net Sales by Business Sector, 2008-2010 396 Table 13.9: Alere, Inc. Financial Figures�Net Sales by Geographic Region, 2008-2010 396 Table 13.10: Bayer AG Financial Figures�Net Sales by Business Sector, 2008-2010 402 Table 13.11: Bayer AG Financial Figures�Net Sales by Geographic Region, 2008-2010 402 Table 13.12: Bio-Rad Laboratories, Inc. Financial Figures�Net Sales by Business Sector, 2008-2010 408 Table 13.13: Bio-Rad Laboratories, Inc. Financial Figures�Net Sales by Geographic Region, 2008-2010 408 Table 13.14: Johnson & Johnson Financial Figures�Net Sales by Major Medical and Diagnostics Businesses, 2008-2010 417 Table 13.15: Quidel Product Distribution and Sales, 2009 and 2010 434 Table 13.16: Danaher Corporation Financial Figures�Net Sales by Business Sector, 2008-2010 437 Table 13.17: Danaher Corporation Financial Figures�Net Sales by Geographic Region, 2008-2010 438 Table 13.18: Roche Group Financial Figures�Net Sales by Business Sector, 2008-2010 442 Table 13.19: Roche Group Financial Figures�Net Sales by Geographic Region, 2009 and 2010 443 Table 13.20: Roche Group Financial Figures�Net Sales by Sub-Division, 2008-2010 443 Table 14.1: Improvements in Achieving ED Operational Efficiency Using POCT 452 Table 14.2: Test Menu and TAT for ED 453 Table 14.3: Top Reasons Why POC Cardiac Marker Testing is Implemented in the ED 453 Table 14.4: Key Areas and Metrics that Hospitals Measure to Assess Efficiency of ED 454 Table 14.5: Estimates of Patient Costs by DRG 455 [Tabellenverzeichnis ausblenden] |
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