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Abstract

Receive a thorough overview of the evolving field of rapid viral testing with D&MDs Rapid Viral Testing Report, including market forecasts through 2010. This Report will provide the most up-to-date survey of rapid viral testing technologies and products that are available, illustrated with recent case studies and providing analyses of savings and medical as well as logistical benefits.

Table of Contents

Chapter 1: Executive Summary 1--1

Chapter 2: The Rationale of Rapid Infectious Disease Testing 2--1

• What Does "Rapid" Mean in Infectious Disease Testing? 2--1
• When "Rapid" Means "Rapid and Easy:" Testing Outside the Laboratory 2--2
• Home Testing and Home Collection/Mail-In Tests 2--3
• Where Time Savings Can Make a Therapeutic Difference 2--3
• Healthcare Resource Allocation 2--4
• Targeted Screening 2--4
• Occupational Exposure 2--4
• Bioterrorism Countermeasures 2--4
• Regulatory Considerations for Rapid Viral Testing 2--5
• Privacy Issues 2--6

Chapter 3: Current and Emerging Rapid Testing Technologies 3--1

• Testing Matrices 3--1
• Whole Blood and Dried Blood Spots 3--1
• Dried Blood Spots (DBS) 3--1
• Urine 3--2
• Saliva and Oral Mucosal Transudate 3--2
• Rapid Serological Tests 3--3
• Immunochromatography: The Lateral Flow Principle 3--3
• Flow-Through Devices 3--4
• Solid Phase Devices 3--5
• CANARY: An Example for an Unconventional Antigen Detection Principle 3--5
• Nucleic Acid Based Tests 3--6
• The Polymerase Chain Reaction (PCR) and its Derivative Technologies 3--7
• TaqMan and Modifications 3--9
• Loop-Mediated Isothermal (LAMP) Assay 3--11
• Conjugated Peptide Nucleic Acid (PNA) Tests 3--11
• Rapid Electron Microscopy 3--12

Chapter 4: The Testing Targets and the Tests 4--1

• HIV Detection and Typing 4--1
• FDA-Approved HIV Antibody Tests 4--3
• OraQuick Rapid HIV-1/2 Test 4--4
• Reveal Rapid HIV Antibody Test 4--6
• Multi-Spot HIV-1/HIV-2 Test 4--6
• Uni-Gold Recombigen HIV Test 4--6
• HIV Rapid Genotyping: Monitoring Drug Resistance 4--9
• Hepatitis Viruses 4--11
• Hepatitis A and E 4--11
• Hepatitis B 4--12
• Hepatitis B Rapid Tests Worldwide 4--14
• Microarrays--Not yet a Factor in Hepatitis B Rapid Typing 4--16
• Hepatitis C 4--16
• HCV Genotyping 4--19
• Combined HIV and HCV Infection--A Mounting Challenge 4--20
• Febrile Respiratory Infections: Leading Killers Worldwide 4--21
• Influenza 4--21
• Severe Acute Respiratory Syndrome (SARS) 4--25
• Respiratory Syncytial Virus (RSV) 4--27
• Enteroviruses 4--29
• West Nile Virus 4--30
• Viral Hemorrhagic Fevers 4--31
• Dengue 4--31
• Ebola 4--33
• Herpes Simplex Viruses 4--33
• Infectious Mononucleosis 4--35
• Papillomavirus 4--36
• Smallpox--The Most Significant Viral Bioterrorism Agent 4--37
• Rabies 4--40
• Prion Diseases 4--41

Chapter 5: Markets and Market Dynamics for Rapid Viral Tests 5--1

• HIV and HCV Diagnostics--Driven by Both Point of Care and Molecular Tests 5--1
• The Fluctuating Rapid Test Market for Respiratory Diseases 5--3
• Viral Hemorrhagic Fevers and West Nile Virus--Another Significant Potential for Rapid Tests 5--4
• International Developments 5--4
• A Paradigm Change is Imminent During 2005-2010 5--5
• Summary 5--5

Chapter 6: Developers and Vendors: Selected Corporate Profiles 6--1

• Acon Laboratories 6--1
• Artus GmbH 6--2
• Bio-Rad Laboratories 6--3
• Becton Dickinson Diagnostic Systems 6--4
• Calypte Biomedical Corp. 6--5
• Genelabs Diagnostics Pte Ltd 6--7
• Inverness Medical Innovations, Inc. 6--8
• Medical Services International, Inc. 6--9
• MedMira Laboratories, Inc. 6--10
• OraSure Technologies, Inc. 6--11
• Roche Diagnostics 6--12
• Roche Molecular Systems, Inc. 6--12
• Saliva Diagnostic Systems, Inc. 6--13

TABLE OF EXHIBITS

• Exhibit 3.1 Lateral Flow Device Scheme 3--4
• Exhibit 3.2 Flow-Through Device Scheme 3--5
• Exhibit 3.3 CANARY・Biosensor Detection of Viral Pathogens. 3--6
• Exhibit 3.4 The Principle of the Polymerase Chain Reaction (PCR) 3--8
• Exhibit 3.5 The TaqMan Principle 3--10
• Exhibit 4.1 FDA-Approved Rapid HIV Test Kits 4--3
• Exhibit 4.2 Performance Characteristics of FDA-Approved Rapid HIV Tests Compared to a Typical FDA-Approved Immunoassay under Various Conditions of HIV Prevalence 4--4
• Exhibit 4.3 The OraQuick Test 4--5
• Exhibit 4.4 The BioRad Multi-Spot Rapid HIV-1/HIV-2 Test 4--6
• Exhibit 4.5 The Trinity Biotech Uni-Gold Recombigen HIV Assay 4--7
• Exhibit 4.6 Selected Internationally Available Rapid HIV Antibody Tests without FDA Approval 4--8
• Exhibit 4.7 Typical Serological Time Profile in Uncomplicated Hepatitis B 4--13
• Exhibit 4.8 Selected Internationally Available Rapid Hepatitis B Tests 4--15
• Exhibit 4.9 Transmission Routes for Hepatitis C Virus 4--17
• Exhibit 4.10 Estimated and Acute Cases of HCV Infection, USA 1982-2001 4--18
• Exhibit 4.11 Selected Internationally Available Rapid Hepatitis C Tests 4--19
• Exhibit 4.12 Performance Characteristics of Rapid Influenza Assays available in the United States (as per manufacturer data) 4--25
• Exhibit 4.13 Distribution of Dengue Fever, 2000 4--32
• Exhibit 4.14 Sequence-Predicted (left row) versus Actual (right row) Patterns of Microchip-Based Hybridization of Amplified Orthopox Virus Nucleic Acids using Fluorescence Detection 4--39