Table of Contents:
Point of Care Testing
Executive summary
Market overview
POC testing in diabetes
Fertility-related tests
Hemostasis testing
Cardiology tests
Infectious disease tests
Drugs of abuse testing
Clinical chemistry and other rapid tests
Company profiles
Market analysis and forecasts
Chapter 1 Market overview
Summary
The shift to POC diagnostic testing
Locations for POC testing
Background on IVD technologies
Clinical chemistry
Immunoassays
Nucleic acid testing
Technologies for POC testing
Lateral-flow tests
Next-generation lateral-flow devices
Electrochemical enzymatic tests
Advances in microfluidics
Data management and connectivity
Market drivers
Market restraints
Regulation of in vitro diagnostic tests (US)
CLIA
Chapter 2 POC testing in diabetes
Summary
Diabetes diagnostics and monitoring
Meter systems for blood glucose monitoring
Increasing performance requirements
Examples of POC device manufacturers
Roche Diagnostics
Arkray
Home Diagnostics
Abbott Diabetes Care
Nova Biomedical
Epocal
Diagnostic Devices
HemoCue
Luminous Medical
Health-Chem Diagnostics
Continuous glucose monitoring systems
Examples of POC device manufacturers
DexCom
Medtronic MiniMed
Abbott Diabetes Care
HbA1c testing
Examples of POC device manufacturers
Diazyme Laboratories
HemoCue
Bio-Rad Laboratories
Siemens
Trinity Biotech
Chapter 3 Fertility-related tests
Summary
Introduction
Pregnancy (hCG) tests
Detection of hCG variants
Ovulation tests
OTC pregnancy test kits
Examples of manufacturers of pregnancy tests
Inverness Medical Innovations
Swiss Precision Diagnostics
Church & Dwight
Siemens Healthcare Diagnostics
Applied DNA Technologies
Quidel
BTNX
Germaine Laboratories
Other fertility-related tests
Chapter 4 Hemostasis testing
Summary
Introduction
Hemostasis modulation
Use of anticoagulants
Use of antiplatelets
Hemostasis testing
Coagulation testing
Prothrombin time
Activated partial thromboplastin time
Activated coagulation time
Guidelines on POC coagulation testing (US)
Examples of manufacturers of POC tests
Abbott Laboratories
Axis-Shield
Siemens
Instrumentation Laboratory
Haemoscope
Helena Point of Care
Inverness Medical Innovations
International Technidyne
Roche Diagnostics
Akers Biosciences
Platelet function tests
POC testing
Examples of manufacturers of POC tests
Helena Point of Care
Siemens Healthcare Diagnostics
Accumetrics
Chapter 5 Cardiology tests
Summary
Overview of cardiovascular disease
Lipids associated with atherosclerosis
Lipid management guidelines (US)
Laboratory lipid profiling
Mail-in fingerstick tests
Point-of-care lipid tests
Routine assay methods
Examples of manufacturers of CLIA waived tests
AccuTech
Inverness Medical Innovations
Polymer Technology Systems
Abaxis
Cardiac protein biomarker diagnostics
Biomarkers of necrosis
Biomarkers of hemodynamic stress
Biomarker panels for risk stratification
The need for POC testing
Examples of manufacturers of POC tests
Siemens
Inverness Medical Innovations
ELITech Group
Roche Diagnostics
Response Biomedical
Abbott Point of Care
Chapter 6 Infectious disease tests
Summary
Introduction
POC testing
Rapid immunoassays
Nucleic acid testing
Sexually-transmitted diseases
HIV
Chlamydia
HPV
HSV-2
Trichomonas vaginalis
Gonorrhea
Respiratory infections
Influenza A and B
Influenza A swine flu
RSV
Strep A
Legionella
M. tuberculosis
Gastrointestinal infections
H. pylori
C. difficile
Parasites
Other infections/conditions
Enteroviral meningitis
Infectious mononucleosis
Hepatitis C
Strep B
MRSA
Sepsis
Malaria
Acute conjunctivitis
Platelet-associated bacteria
Periodontal disease
Urine infection
Chapter 7 Drugs of abuse testing
Summary
Introduction
Point-of-care urine-based testing
Commonly abused prescription drugs
Opioids
Central nervous system depressants
Stimulants
Psychoactive drugs
Methadone
Illicit drugs
Methamphetamine
Cocaine
Heroin
Phencyclidine
Cannabinoids
POC testing sites
CLIA waived DOA rapid tests
Examples of POC DOA test manufacturers
Inverness Medical Innovations
Nanogen
Bio-Rad Laboratories
Siemens Healthcare Diagnostics
Instant Technologies
NOVX Systems
Detection of DOA in oral fluids
Chapter 8 Clinical chemistry and other rapid tests
Summary
Introduction
Urinalysis reagent strips
Automated urinalysis
POC clinical chemistry analyzers
Examples of manufacturers
Abaxis
Abbott Laboratories
Arkray
Cancer POC testing
Colon cancer screening
Bladder cancer screening
Other products
Chapter 9 Company profiles
Summary
Abaxis Inc
Company description
POC technology/products
Abbott Laboratories
Company description
POC technology/products
Accumetrics
Company description
POC technology/products
AccuTech LLC
Company description
POC technology/products
Akers Biosciences Inc
Company description
POC technology/products
American Bio Medica Corporation
Company description
POC technology/products
AmniSure International LLC
Company description
POC technology/products
Arkray USA Inc
Company description
POC technology/products
Banyan Biomarkers Inc
Company description
POC technology/products
BioHelix Corporation
Company description
POC technology/products
Bio-Rad Laboratories Inc
Company description
POC technology/products
BiOracle Ltd
Company description
POC technology/products
Calypte Biomedical Corporation
Company description
POC technology/products
Cepheid
Company description
POC technology/products
Diazyme Laboratories
Company description
POC technology/products
ELITech Group
Company description
POC technology/products
Enigma Diagnostics Ltd
Company description
POC technology/products
GeneEx Inc
Company description
POC technology/products
Health-Chem Diagnostics LLC
Company description
POC technology/products
Helena Laboratories Corporation
Company description
POC technology/products
Home Diagnostics Inc.
Company description
POC technology/products
International Technidyne Corporation
Company description
POC technology/products
Inverness Medical Innovations Inc
Company description
POC technology/products
Meso Scale Diagnostics LLC
Company description
POC technology/products
Micronics
Company description
POC technology/products
Molecular Vision Ltd
Company description
POC technology/products
NOVX Systems Inc
Company description
POC technology/products
OraSure Technologies Inc
Company description
POC technology/products
Phadia AB
Company description
POC technology/products
PointCare Technologies Inc
Company description
POC technology/products
Polymer Technology Systems Inc
Company description
POC technology/products
Princeton BioMeditech Corporation
Company description
POC technology/products
Qualigen Inc
Company description
POC technology/products
Quidel Corporation
Company description
POC technology/products
Rapid Pathogen Screening Inc
Company description
POC technology/products
Response Biomedical Corporation
Company description
POC technology/products
Roche Diagnostics Corporation
Company description
POC technology/products
Siemens Healthcare Diagnostics Inc
Company description
POC technology/products
Trinity Biotech Plc
Company description
POC technology/products
Verax Biomedical Inc
Company description
POC technology/products
Chapter 10 Market analysis and forecasts
Summary
Outlook for the POCT market
Forecasts for individual POCT market sectors
Glucose monitoring
HbA1c testing
Pregnancy/fertility testing
Infectious disease testing
Lipid profiling
Cardiac marker testing
Coagulation testing
Drugs of abuse testing
Automated urine/blood analysis
Cancer screening
Penetrating the healthcare system
POCT in retail health clinics
POCT in physicians office labs
Future POCT technologies
Appendix
Research methodology
Glossary
List of Figures
Figure 1.1: Approaches to overcoming limitations of traditional PCR-based assays
Figure 1.2: A representative basic lateral flow immunoassay (LFI) device
Figure 1.3: Schematic of an electrochemical glucose biosensor with meter display
Figure 1.4: Schematic of a lab-on-a-chip device
Figure 1.5: Drivers & restraints for the POCT market
Figure 2.6: Patient potential for type 2 diabetes
Figure 2.7: Causes of inaccurate glucose test results
Figure 6.8: Infectious disease tests CLIA waived (%), Nov 2006 - Oct 2009
Figure 6.9: GeneXpert system for PCR-based DNA testing
List of Tables
Table 2.1: Glucose monitoring products 2006-09
Table 2.2: Glucose monitoring products 2006-09 (ctd 1)
Table 2.3: Glucose monitoring products 2006-09 (ctd 2)
Table 2.4: Glucose monitoring products 2006-09 (ctd 3)
Table 2.5: Glucose monitoring products 2006-09 (ctd 4)
Table 2.6: Glucose monitoring products 2006-09 (ctd 5)
Table 2.7: HbA1c testing products
Table 3.8: Pregnancy and ovulation tests
Table 3.9: Pregnancy and ovulation tests (ctd 1)
Table 3.10: Pregnancy and ovulation tests (ctd 2)
Table 3.11: Pregnancy and ovulation tests (ctd 3)
Table 5.12: Lipid profiling tests
Table 6.13: Infectious disease tests - Strep A infection
Table 6.14: Infectious disease tests - H. pylori infection
Table 6.15: Infectious disease tests - Infectious mononucleosis
Table 6.16: Infectious disease tests - HIV infection
Table 6.17: Infectious disease tests - influenza A/B infection
Table 6.18: Infectious disease tests - urinary infection
Table 7.19: Drugs of abuse (DOA) test systems and analytes
Table 7.20: Drugs of abuse (DOA) test systems and analytes (ctd 1)
Table 7.21: Drugs of abuse (DOA) test systems and analytes (ctd 1)
Table 8.22: Automated urine analyzers/reagents
Table 8.23: Automated urine analyzers/reagents (ctd 1)
Table 8.24: Automated urine analyzers/reagents (ctd 2)
Table 8.25: Blood chemistry analyzers/reagents
Table 8.26: Blood chemistry analyzers/reagents (ctd 1)
Table 8.27: Immunological Fecal Occult Blood (FOB) tests
Table 9.28: Abbott Laboratories sales to external customers ($m), 2006-08
Table 9.29: Cepheid product sales by market ($ thousands), 2007-08
Table 9.30: Inverness Medical Innovations sales ($ thousands), 2007-08
Table 9.31: Quidel POC diagnostic revenues ($ thousands), 2007-08
Table 10.32: POCT market forecast by application, 2008-13
Table 10.33: POCT market forecast by region, 2008-13