Rapid Viral Testing

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