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Point of Care Diagnostic Testing World Markets

TriMark Publications
February 1, 2012
460 Pages - SKU: TRI6823082

Abstract Table of Contents Related Reports

Countries covered: Global

Point of Care Diagnostic Testing World Markets

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.

1. Overview: 1.1 About This Report; 1.2 Scope of the Report; 1.3 Objectives; 1.4 Methodology; 1.5 Executive Summary
2. Overview of Diagnostic Testing Point of Care: 2.1 Key Issues in the Point of Care Diagnostic Testing Sector; 2.2 Global Point of Care Marketplace; 2.3 Shifts from Central Lab Testing to POCT; 2.4 Geographical Distribution; 2.5 Challenges of POCT; 2.6 Key Issues for POCT; 2.7 The Future of POCT
3. Summary Analysis of the Global POCT Market: Value, Growth Rates and Market Share: 3.1 Global POCT Market
4. Analysis of the U.S. POCT Market: Value, Growth Rates and Market Share
5. Analysis of the European POCT Market: Value, Growth Rates and Market Shares
6. Analysis of the POCT Markets for Japan, China and India: Value, Growth Rates and Market Share: 6.1 Summary Analysis of the Japanese POCT Market; 6.2 Summary Analysis of the Indian POCT Market; 6.3 Summary Analysis of the Chinese POCT Market
7. Analysis of the Rest of World (ROW) POCT Market: Value, Growth Rates and Market Share: 7.1 Summary Analysis of the ROW POCT Market Revenues
8. Review of the Market Segments, Reagents and Equipment: 8.1 Blood Glucose Monitoring; 8.2 Blood Gas and Electrolytes; 8.3 Rapid Coagulation Tests; 8.4 POC Rapid Cardiac Markers; 8.5 POC Substance Abuse Testing; 8.6 POC Pregnancy and Fertility Tests; 8.7 Fecal Occult Blood; 8.8 POC Infectious Disease Testing; 8.9 POC Urine Strip Testing; 8.10 POC Cholesterol Testing; 8.11 Miscellaneous POC Tests; 8.12 POC Vaginal Fluid pH and Vaginitis Testing; 8.13 POC Cancer Testing; 8.14 Fetal Status (PROM); 8.15 Osteoporosis; 8.16 Hemodynamic Monitoring; 8.17 Heparin-Induced Thrombocytopenia; 8.18 HIV; 8.19 Infectious Disease; 8.20 Homeland Defense (Plague and Tularemia); 8.21 BSE (Mad Cow Disease); 8.22 Tuberculosis; 8.23 Typhoid; 8.24 Avian Flu; 8.25 Food Pathogens (Salmonella, Listeria, Campylobacter); 8.26 Ruptured Fetal Membranes; 8.27 Alcohol; 8.28 Microalbumin Testing; 8.29 Labor and Delivery Testing; 8.30 Sperm Fertility; 8.31 Surgical Coagulation and Hemostasis Management; 8.32 Respiratory Tests; 8.33 C-Reactive Protein
9. POCT: Growth Regulators: 9.1 Moderators of Growth; 9.2 Personnel Acceptance; 9.3 Key People for POCT; 9.4 Information Management Issues; 9.5 Key Elements for POCT; 9.6 POCT and Reimbursement; 9.7 Effectiveness of Clinical Outcomes; 9.8 Rapid Near-Patient Testing in Hospitals; 9.9 Satellite Facilities; 9.10 Regionalization of Laboratory Care; 9.11 Requirements for POCT; 9.12 Locations of Point of Care for Patient Care; 9.13 Benefits of POCT; 9.14 Cost Elements of POCT; 9.15 Necessary Functions in POCT; 9.16 Turnaround Time (TAT) for POCT; 9.17 Clinical Laboratory Improvement Amendments (CLIA); 9.18 Sexually-Transmitted Diseases in Underdeveloped Countries; 9.19 Sources of Error in POC Testing
10. Business Trends in the POC Sector: 10.1 Sector Consolidation; 10.2 Diagnostic Testing Growth Trends; 10.3 Acquisition, License Agreements, Internal Development and Partnerships; 10.4 Product Testing Depth in POCT; 10.5 Government Regulation; 10.6 Post-Filing Regulations for POC Devices; 10.7 Exporting Unapproved POCTs; 10.8 Analyte-Specific Reagents (Home Brew Tests); 10.9 Medical Device Registration; 10.10 Product Labeling; 10.11 Punitive FDA Actions; 10.12 CLIA ’88 and State Laboratory Laws; 10.13 Impact of Regulations on the Industry; 10.14 Minimizing Regulatory Barriers; 10.15 Waived Testing
11. Technology Platform Innovations in POCT: 11.1 Latest POCT Technological Platforms; 11.2 Developments in Key Technologies; 11.3 Sensor Systems for Diagnostic Applications; 11.4 Nanogen (The ELITech Group) Third-Generation POC Analyzer; 11.5 Philips Development of Magnotech Technology; 11.6 Quidel Corporation MChip, AVR Chip and F Chip; 11.7 Sanofi-Aventis
12. Data Management and Connectivity: 12.1 Wireless LANs; 12.2 Connectivity Platforms; 12.3 Advantages of POCT Connectivity; 12.4 POCT Analyzer Connectivity Software Solutions; 12.5 POCT2-P
13. Corporate Profiles: 13.1 Abaxis, Inc.; 13.2 Abbott Laboratories; 13.3 Accumetrics, Inc.; 13.4 AccuTech, LLC; 13.5 ACON Laboratories, Inc.; 13.6 Acrongenomics; 13.7 AgaMatrix; 13.8 Aerscher Diagnostics; 13.9 Akers Biosciences, Inc.; 13.10 Alere; 13.11 Alfa Scientific Designs, Inc.; 13.12 American Bio Medica Corporation; 13.13 Ani Biotech Oy Ltd.; 13.14 Ark Therapeutics; 13.15 Arkray, Inc.; 13.16 Atonomics A/S; 13.17 Audit Diagnostics; 13.18 Augurix Diagnostics Ltd.; 13.19 Axis-Shield; 13.20 Axxin; 13.21 Bayer Corp.; 13.22 Beckman Coulter; 13.23 BioLytical Laboratories; 13.24 Biomerica, Inc.; 13.25 bioMérieux; 13.26 BiOracle; 13.27 Bio-Rad Laboratories, Inc.; 13.28 BioScan Screening Systems, Inc.; 13.29 BioSite; 13.30 Calmark Sweden AB; 13.31 Calypte Biomedical Corporation; 13.32 Chembio Diagnostic, Inc; 13.33 Chempaq A/S; 13.34 Cholestech; 13.35 Claros Diagnostics; 13.36 CompuCyte Corporation; 13.37 Concateno Plc; 13.38 Diagnostics Chemicals Ltd.; 13.39 Dexcom; 13.40 Enigma Diagnostics Ltd.; 13.41 EY Laboratoires, Inc.; 13.42 Eurotrol; 13.43 Exalenz Bioscience; 13.44 GenBio; 13.45 Genzyme Diagnostics; 13.46 Helena Laboratories; 13.47 Hema Diagnostic Systems, LLC; 13.48 HemoCue AB; 13.49 HemoSense; 13.50 Home Diagnostics (Nipro Diagnostics); 13.51 IND Diagnostic; 13.52 Instrumentation Laboratory (IL)/Werfen Group; 13.53 International Technidyne Corporation; 13.54 Jant Pharmacal Corporation; 13.55 Johnson & Johnson; 13.56 Lein Applied Diagnostics; 13.57 LifeAssays AB; 13.58 LifeSign, LLC; 13.59 Medica; 13.60 Medical Automation Systems; 13.61 Mediwatch; 13.62 Medix Biochemica; 13.63 MedMira Laboratories; 13.64 MELA Sciences (Formerly Electro-Optical Sciences); 13.65 A. Menarini Diagnostics; 13.66 Meretek Diagnostics Group; 13.67 Meridian Bioscience; 13.68 Micronics; 13.69 Minimed; 13.70 Mitsubishi Chemical Holdings USA, Inc.; 13.71 Mitsubishi Kagaku Iatron; 13.72 Nanogen (ELITech Group); 13.73 New Horizons Diagnostics; 13.74 Nexus DX/ITC; 13.75 Nova Biomedical; 13.76 OraSure Technologies, Inc; 13.77 Orion Diagnostica; 13.78 Polymedco, Inc.; 13.79 Polymer Technology Systems, Inc.; 13.80 Prima Biomedical Company; 13.81 QBC Diagnostics; 13.82 Qualigen; 13.83 Quest Diagnostics, Inc.; 13.84 Quidel Corporation; 13.85 Radiometer Medical; 13.86 Response Biomedical; 13.87 Roche Diagnostics; 13.88 Savyon Diagnostics; 13.89 Selfcare, Inc.; 13.90 Shionogi & Co., Ltd.; 13.91 Siemens AG; 13.92 Guided Therapeutics, Inc. (SpectRx, Inc.); 13.93 Spectral Diagnostics; 13.94 StatSure Diagnostic Systems, Inc.; 13.95 Strategic Diagnostics; 13.96 Trinity Biotech, Plc; 13.97 Väsamed, Inc.
14. POCT Sector Trends and Forecasts: 14.1 Home Care Analysis as Part of Near-Patient Testing; 14.2 Non-Traditional Collection for POCT; 14.3 New Systems for Critical Care and Near-Patient Testing; 14.4 Utility of Near-Patient Testing in Critical-Care Settings; 14.5 Physician’s Office Market; 14.6 Information Management Advances; 14.7 Test-Ordering Patterns and Demand for POCT; 14.8 Demand for Emergency Department Services; 14.9 Move Away from the Central Laboratory; 14.10 Healthcare Cost Controls; 14.11 Mergers and Acquisitions in POCT; 14.12 Competition for Services; 14.13 Drivers of POCT; 14.14 Confluence of New Technology; 14.15 Difficulties of Design for POC Products; 14.16 European Hospital Structure; 14.17 The Biggest New Opportunities in POCT
15. Corporate Directory
INDEX OF FIGURES: Figure 2.1: Worldwide Distribution of IVD Testing, 2011; Figure 2.2: Top 13 Country IVD Testing Markets, 2011; Figure 2.3: Company Market Share for IVD Testing Markets, 2011; Figure 3.1: Total Global POCT Market, 2008-2018; Figure 3.2: Worldwide Distribution of POCT, 2011; Figure 3.3: Summary of Global POCT Markets by Market Segment, 2011; Figure 4.1: U.S. Revenues for POCT Market, 2008-2018; Figure 4.2: Summary of U.S. POCT Markets by Market Segment, 2011; Figure 5.1: European Revenues for POCT Market, 2008-2018; Figure 6.1: Summary Analysis of Japanese, Chinese and Indian POCT Market, 2008-2018; Figure 6.2: Japanese Revenues for POCT Market, 2008-2018; Figure 6.3: Indian Revenues for POCT Market, 2008-2018; Figure 6.4: Chinese Revenues for POCT Market, 2008-2018; Figure 7.1: Summary Analysis of the ROW POCT Market, 2008-2018; Figure 7.2: Summary Analysis of the Russian Revenues for POC Testing Products Market, 2008-2018; Figure 7.3: Summary Analysis of the Middle East Revenues for POC Testing Products Market, 2008-2018; Figure 7.4: Summary Analysis of the African Revenues for POC Testing Products Market, 2008-2018; Figure 7.5: Summary Analysis of the Latin America (Other) Revenues for POC Testing Products Market, 2008- 2018; Figure 8.1: Global POCT Share of Glucose Testing Market, 2011; Figure 8.2: Global POCT Share of Blood Gas and Electrolyte Testing Market, 2011; Figure 8.3: Global POCT Share of Coagulation Testing Market, 2011; Figure 8.4: Global POCT Share of Cardiac Marker Testing Market, 2011; Figure 8.5: Global POCT Share of HIV Testing Market, 2008; Figure 8.6: Performance Metrics of ROM Diagnostic Methods; Figure 9.1: Annual Rate of Emergency Room Visits by Primary Expected Source of Payment; Figure 9.2: CLIA Laboratories by Certificate Types; Figure 10.1: Conformity Assessment Route, Annexes and Quality System Standards by IVD Device Category
INDEX OF TABLES: Table 1.1: Summary of Global POCT Markets by Major Market Sub-Segment, 2011 and; 2018; Table 1.2: Summary of U.S. POCT Markets by Major Market Sub-Segment, 2011 and; 2018; Table 1.3: Summary of European POCT Markets by Major Market Sub-Segment, 2011; and 2018; Table 1.4: Summary of Asian POCT Markets by Major Market Sub-Segment, 2011 and; 2018; Table 1.5: Summary of ROW POCT Markets by Major Market Sub-Segment, 2011 and; 2018; Table 1.6: Worldwide POCT Market Size by Geographic Location, 2008-2018; Table 1.7: Global Market Share Analysis, 2011; Table 2.1: POCT Frequency in Hospitals; Table 2.2: Worldwide Distribution of IVD Testing, 2011; Table 2.3: Top 13 Country IVD Testing Markets, 2011; Table 2.4: Company Market Share for IVD Testing Markets, 2011; Table 2.5: Competitive Landscape for Point of Care Diagnostic Testing; Table 3.1: Total Global POCT Market, 2008-2018; Table 3.2: Global Revenues for POC Blood Glucose Monitoring Systems, 2008-2018; Table 3.3: Global Revenues for POC Blood Gas and Electrolyte Analyzers,; 2008-2018; Table 3.4: Global Revenues for POC Rapid Coagulation Analyzer Systems, 2008-2018; Table 3.5: Global Revenues for POC Cardiac Marker Devices, 2008-2018; Table 3.6: Global Revenues for POC Substance/Drug Abuse Testing Device Market,; 2008-2018; Table 3.7: Global Revenues for POC Infectious Disease Testing Devices Market,; 2008-2018; Table 3.8: Global Revenues for POC Urine Strip Testing Products Market,; 2008-2018; Table 3.9: Global Revenues for POC Pregnancy Testing Devices Market, 2008-2018; Table 3.10: Global Revenues for POC Fecal Occult Testing Devices Market,; 2008-2018; Table 3.11: Global Revenues for POC Cholesterol Testing Products Market,; 2008-2018; Table 3.12: Global POCT Market Share Analysis, 2011; Table 3.13: Worldwide POCT Market Size by Geographic Location, 2008-2018; Table 3.14: Worldwide Distribution of POCT, 2011; Table 3.15: Summary of Global POCT Markets by Market Segment, 2011; Table 3.16: Worldwide POCT by Performance Location, 2011; Table 4.1: U.S. Revenues for POCT Market, 2008-2018; Table 4.2: U.S Revenues for POC Blood Glucose Monitoring Systems, 2008-2018; Table 4.3: U.S Revenues for POC Blood Gas and Electrolyte Analyzers, 2008-2018; Table 4.4: U.S. Revenues for POC Rapid Coagulation Analyzer Systems, 2008-2018; Table 4.5: U.S. Revenues for POC Cardiac Marker Devices, 2008-2018; Table 4.6: U.S Manufacturer Market Share U.S. POCT Cardiac Marker Market, 2011; Table 4.7: U.S. Revenues for POC Substance/Drug Abuse Testing Device Market,; 2008-2018; Table 4.8: U.S. Revenues for POC Infectious Disease Testing Devices Market,; 2008-2018; Table 4.9: U.S. Revenues for POC Urine Strip Testing Products Market, 2008-2018; Table 4.10: U.S. Revenues for POC Pregnancy Testing Devices Market, 2008-2018; Table 4.11: U.S. Revenues for POC Fecal Occult Testing Devices Market, 2008-2018; Table 4.12: U.S. Revenues for POC Cholesterol Testing Products Market, 2008-2018; Table 4.13: U.S. POCT Market Share Analysis, 2011; Table 4.14: U.S. POCT by Performance Location, 2010; Table 4.15: Summary of U.S. POCT Markets by Market Segment, 2011; Table 5.1: Models of Public-Private Partnership in Hospital Provision; Table 5.2: European Revenues for POCT Market, 2008-2018; Table 5.3: French Revenues for POCT Systems, 2008-2018; Table 5.4: German Revenues for POCT Systems, 2008-2018; Table 5.5: Italian Revenues for POCT Systems, 2008-2018; Table 5.6: Spanish Revenues for POCT Systems, 2008-2018; Table 5.7: U.K. Revenues for POCT Systems, 2008-2018; Table 5.8: Benelux Revenues for POCT Systems, 2008-2018; Table 5.9: Scandinavian Revenues for POCT Systems, 2008-2018; Table 5.10: Rest-of-Europe Revenues for POCT Systems, 2008-2018; Table 5.11: European Revenues for POC Blood Glucose Monitoring Systems, 2008-2018; Table 5.12: European Revenues for POC Blood Gas and Electrolyte Analyzers, 2008-2018; Table 5.13: European Revenues for POC Rapid Coagulation Analyzer Systems, 2008-2018; Table 5.14: European Revenues for POC Cardiac Marker Devices, 2008-2018; Table 5.15: European Revenues for POC Substance/Drug Abuse Testing Device Market, 2008-2018; Table 5.16: European Revenues for POC Infectious Disease Testing Devices Market, 2008-2018; Table 5.17: European Revenues for POC Urine Strip Testing Products Market, 2008-2018; Table 5.18: European Revenues for POC Pregnancy Testing Devices Market, 2008-2018; Table 5.19: European Revenues for POC Fecal Occult Testing Devices Market, 2008-2018; Table 5.20: European Revenues for POC Cholesterol Testing Products Market, 2008-2018; Table 5.21: European Market Share Analysis, 2011; Table 6.1: Summary Analysis of Japanese, Chinese and Indian POCT Market, 2008-2018; Table 6.2: Summary Analysis of Japanese, Chinese and Indian Revenues for POC; Blood Glucose Monitoring Systems, 2008-2018; Table 6.3: Summary Analysis of Japanese, Chinese and Indian Revenues for POC Blood Gas and Electrolyte Analyzers, 2008-2018; Table 6.4: Summary Analysis of Japanese, Chinese and Indian Revenues for POC Rapid Coagulation Analyzer Systems, 2008-2018; Table 6.5: Summary Analysis of Japanese, Chinese and Indian Revenues for POC Cardiac Marker Devices, 2008-2018; Table 6.6: Summary Analysis of Japanese, Chinese and Indian Revenues for POC Substance/Drug Abuse Testing Device Market, 2008-2018; Table 6.7: Summary Analysis of Japanese, Chinese and Indian Revenues for POC Infectious Disease Testing Devices Market, 2008-2018; Table 6.8: Summary Analysis of Japanese, Chinese and Indian Revenues for POC Urine Strip Testing Products Market, 2008-2018; Table 6.9: Summary Analysis of Japanese, Chinese and Indian Revenues for POC Pregnancy Testing Devices Market, 2008-2018; Table 6.10: Summary Analysis of Japanese, Chinese and Indian Revenues for POC Fecal Occult Testing Devices Market, 2008-2018; Table 6.11: Summary Analysis of Japanese, Chinese and Indian Revenues for POC Cholesterol Testing Products Market, 2008-2018; Table 6.12: Summary Analysis of Japanese, Chinese and Indian Market Shares, 2011; Table 6.13: Japanese Population and Aging Demographics Forecast, 2000-2050; Table 6.14: Japanese Revenues for POCT Market, 2008-2018; Table 6.15: Indian Revenues for POCT Market, 2008-2018; Table 6.16: Chinese Revenues for POCT Market, 2008-2018; Table 7.1: Summary Analysis of the ROW POCT Market, 2008-2018; Table 7.2: Summary Analysis of ROW Revenues for POC Blood Glucose Monitoring Systems, 2008-2018; Table 7.3: Summary Analysis of ROW Revenues for POC Blood Gas and Electrolyte Analyzers, 2008-2018; Table 7.4: Summary Analysis of ROW Revenues for POC Rapid Coagulation Analyzer Systems, 2008-2018; Table 7.5: Summary Analysis of ROW Revenues for POC Cardiac Marker Devices, 2008-2018; Table 7.6: Summary Analysis of ROW Revenues for POC Substance/Drug Abuse Testing Device Market, 2008-2018; Table 7.7: Summary Analysis of ROW Revenues for POC Infectious Disease Testing Devices Market, 2008-2018; Table 7.8: Summary Analysis of ROW Revenues for POC Urine Strip Testing Products Market, 2008-2018; Table 7.9: Summary Analysis of ROW Revenues for POC Pregnancy Testing Devices Market, 2008-2018; Table 7.10: Summary Analysis of ROW Revenues for POC Fecal Occult Testing Devices Market, 2008-2018; Table 7.11: Summary Analysis of ROW Revenues for POC Cholesterol Testing Products Market, 2008-2018; Table 7.12: Summary Analysis of ROW Market Shares, 2011; Table 7.13: Summary Analysis of Argentinian Revenues for POC Testing Products Market, 2008-2018; Table 7.14: Summary Analysis of Australian Revenues for POC Testing Products Market, 2008-2018; Table 7.15: Summary Analysis of Brazilian Revenues for POC Testing Products Market, 2008-2018; Table 7.16: Summary Analysis of Canadian Revenues for POC Testing Products Market, 2008-2018; Table 7.17: Summary Analysis of Russian Revenues for POC Testing Products Market, 2008-2018; Table 7.18: Summary Analysis of Middle East Revenues for POC Testing Products Market, 2008-2018; Table 7.19: Summary Analysis of African Revenues for POC Testing Products Market, 2008-2018; Table 7.20: Summary Analysis of Asia (Other) Revenues for POC Testing Products Market, 2008-2018; Table 7.21: Summary Analysis of Latin America (Other) Revenues for POC Testing Products Market, 2008-2018; Table 8.1: Summary of Emerging Glucose Sensor Technologies, 2011; Table 8.2: Selected POC Blood Glucose Monitoring Systems, 2011; Table 8.3: Roche Diagnostics Glucose Testing Products; Table 8.4: Market Share of Glucose POCT Diagnostic Testing Companies Worldwide, 2011; Table 8.5: SWOT Analysis: Summary of Strengths, Weaknesses, Opportunities and Threats in the Glucose POC Market; Table 8.6: Selected POC Blood Gas and Electrolyte Analyzers, 2011; Table 8.7: Market Share Blood Gas and Electrolyte POCT Diagnostic Testing Companies Worldwide, 2011; Table 8.8: SWOT Analysis: Summary of Strengths, Weaknesses, Opportunities and; Threats in the Blood Gas and Electrolyte POC Market; Table 8.9: Selected POC Rapid Coagulation Analyzers, 2011; Table 8.10: Actalyke XL; Table 8.11: Actalyke Mini; Table 8.12: Market Share for Coagulation POCT Diagnostic Testing Companies Worldwide, 2011; Table 8.13: SWOT Analysis: Summary of Strengths, Weaknesses, Opportunities and Threats in the Coagulation POC Market; Table 8.14: Selected POC Cardiac Biomarkers, 2011; Table 8.15: Market Share of Cardiac Marker POCT Diagnostic Testing Companies Worldwide, 2011; Table 8.16: POC Cardiac Marker Testing Market: Market Drivers Ranked in Order of Impact; Table 8.17: POC Cardiac Marker Testing Market: Market Restraints Ranked in Order of Impact; Table 8.18: SWOT Analysis: Summary of Strengths, Weaknesses, Opportunities and; Threats in the Cardiac Marker POC Market; Table 8.19: Drug Testing Needs Tier I for Rapid Serum POCT in the Emergency Department; Table 8.20: Stat Urine Testing Drug Recommendations; Table 8.21: Selected POC Substance/Drug Abuse Testing Devices, 2011; Table 8.22: Selected POC Pregnancy Testing Devices, 2011; Table 8.23: Selected POC Fecal Occult Testing Devices, 2011; Table 8.24: ColoCARE Fecal Occult Blood Test; Table 8.25: SWOT Analysis: Summary of Strengths, Weaknesses, Opportunities and Threats in the Fecal Occult Blood Point of Care Market; Table 8.26: Selected POC Infectious Disease Testing Devices, 2011; Table 8.27: Selected POC Urine Strip Testing, 2011; Table 8.28: Selected POC Cholesterol Testing Devices, 2011; Table 8.29: Competitive Factors Related to HIV Tests; Table 8.30: Largest POCT Diagnostic Companies Worldwide, 2008; Table 8.31: Influenza Diagnostic Rapid Tests; Table 8.32: Type of Hepatitis Test: Lateral Flow; Table 8.33: Flow-Through; Table 8.34: Agglutination; Table 8.35: Immunoblot; Table 8.36: AmniSure; Table 9.1: Access Points; Table 9.2: Desktop Adapters—Four Computers; Table 9.3: Desktop Adapters—One Computer; Table 9.4: PCMCIA Adapters; Table 9.5: POCT1-Compliant Connectivity Point of Care Instruments; Table 9.6: POCT Clinical Outcomes in Diabetic Ketoacidosis; Table 9.7: POCT Clinical Outcomes in Arterial Blood Gas Measurements; Table 9.8: POCT in Three Hospitals—Cost Analysis with Labor Included; Table 9.9: POCT versus Central Lab—Cost Analysis for Glucose Testing; Table 9.10: CLIA Laboratories by Type of Facility; Table 9.11: Financial Comparison for Moderate and Waived CLIA Labs; Table 9.12: Top Ten CMS Survey Deficiencies for CLIA Laboratories; Table 10.1: Key Changes in IVD Business Structure; Table 11.1: Common Genotype Techniques; Table 12.1: Applications for Wireless LAN Technology; Table 12.2: Customized Reports Must Support CAP and JCAHO Requirements; Table 12.3: RALS-Plus POC Market Share; Table 12.4: Applications of RALS Connectivity with POCT Devices; Table 13.1: Abaxis Blood Analysis Diagnostic Tests; Table 13.2: Reagent Discs Offered with the Piccolo Chemistry Analyzers; Table 13.3: Abaxis, Inc. Financial Figures—Net Sales by Business Sector, 2008-2010; Table 13.4: Abaxis, Inc. Financial Figures—Net Sales by Geographic Region, 2008-2010; Table 13.5: Products Marketed by Abbott in the Diagnostic Market; Table 13.6: Abbott Laboratories Financial Figures—Net Sales by Business Sector, 2008-2010; Table 13.7: Abbott Laboratories Financial Figures—Net Sales by Geographic Region, 2008-2010; Table 13.8: Alere, Inc. Financial Figures—Net Sales by Business Sector, 2008-2010; Table 13.9: Alere, Inc. Financial Figures—Net Sales by Geographic Region, 2008-2010; Table 13.10: Bayer AG Financial Figures—Net Sales by Business Sector, 2008-2010; Table 13.11: Bayer AG Financial Figures—Net Sales by Geographic Region,; 2008-2010; Table 13.12: Bio-Rad Laboratories, Inc. Financial Figures—Net Sales by Business Sector, 2008-2010; Table 13.13: Bio-Rad Laboratories, Inc. Financial Figures—Net Sales by Geographic Region, 2008-2010; Table 13.14: Johnson & Johnson Financial Figures—Net Sales by Major Medical and Diagnostics Businesses, 2008-2010; Table 13.15: Quidel Product Distribution and Sales, 2009 and 2010; Table 13.16: Danaher Corporation Financial Figures—Net Sales by Business Sector, 2008-2010; Table 13.17: Danaher Corporation Financial Figures—Net Sales by Geographic Region, 2008-2010; Table 13.18: Roche Group Financial Figures—Net Sales by Business Sector, 2008-2010; Table 13.19: Roche Group Financial Figures—Net Sales by Geographic Region, 2009 and 2010; Table 13.20: Roche Group Financial Figures—Net Sales by Sub-Division, 2008-2010; Table 14.1: Improvements in Achieving ED Operational Efficiency Using POCT; Table 14.2: Test Menu and TAT for ED; Table 14.3: Top Reasons Why POC Cardiac Marker Testing is Implemented in the ED; Table 14.4: Key Areas and Metrics that Hospitals Measure to Assess Efficiency of ED; Table 14.5: Estimates of Patient Costs by DRG

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