Rapid Viral Testing

Published by: Drug and Market Development Publishing

Published: Apr. 1, 2005 - 105 Pages

Table of Contents

Chapter 1: Executive Summary

Chapter 2: The Rationale of Rapid Infectious Disease Testing

What Does “Rapid” Mean in Infectious Disease Testing?

When “Rapid” Means “Rapid and Easy:” Testing Outside the Laboratory

Home Testing and Home Collection/Mail-In Tests

Where Time Savings Can Make a Therapeutic Difference

Healthcare Resource Allocation

Targeted Screening

Occupational Exposure

Bioterrorism Countermeasures

Regulatory Considerations for Rapid Viral Testing

Privacy Issues

Chapter 3: Current and Emerging Rapid Testing Technologies

Testing Matrices

Whole Blood and Dried Blood Spots

Dried Blood Spots (DBS)

Urine

Saliva and Oral Mucosal Transudate

Rapid Serological Tests

Immunochromatography: The Lateral Flow Principle

Flow-Through Devices

Solid Phase Devices

CANARY: An Example for an Unconventional Antigen Detection Principle

Nucleic Acid Based Tests

The Polymerase Chain Reaction (PCR) and its Derivative Technologies

TaqMan and Modifications

Loop-Mediated Isothermal (LAMP) Assay

Conjugated Peptide Nucleic Acid (PNA) Tests

Rapid Electron Microscopy

Chapter 4: The Testing Targets and the Tests

HIV Detection and Typing

FDA-Approved HIV Antibody Tests

OraQuick Rapid HIV-1/2 Test

Reveal Rapid HIV Antibody Test

Multi-Spot HIV-1/HIV-2 Test

Uni-Gold Recombigen HIV Test

HIV Rapid Genotyping: Monitoring Drug Resistance

Hepatitis Viruses

Hepatitis A and E

Hepatitis B

Hepatitis B Rapid Tests Worldwide

Microarrays-Not yet a Factor in Hepatitis B Rapid Typing

Hepatitis C

HCV Genotyping

Combined HIV and HCV Infection-A Mounting Challenge

Febrile Respiratory Infections: Leading Killers Worldwide

Influenza

Severe Acute Respiratory Syndrome (SARS)

Respiratory Syncytial Virus (RSV)

Enteroviruses

West Nile Virus

Viral Hemorrhagic Fevers

Dengue

Ebola

Herpes Simplex Viruses

Infectious Mononucleosis

Papillomavirus

Smallpox-The Most Significant Viral Bioterrorism Agent

Rabies

Prion Diseases

Chapter 5: Markets and Market Dynamics for Rapid Viral Tests

HIV and HCV Diagnostics-Driven by Both Point of Care and Molecular Tests

The Fluctuating Rapid Test Market for Respiratory Diseases

Viral Hemorrhagic Fevers and West Nile Virus-Another Significant Potential for Rapid Tests

International Developments

A Paradigm Change is Imminent During 2005-2010

Summary

Chapter 6: Developers and Vendors: Selected Corporate Profiles

Acon Laboratories

Artus GmbH

Bio-Rad Laboratories

Becton Dickinson Diagnostic Systems

Calypte Biomedical Corp.

Genelabs Diagnostics Pte Ltd

Inverness Medical Innovations, Inc.

Medical Services International, Inc.

MedMira Laboratories, Inc.

OraSure Technologies, Inc.

Roche Diagnostics

Roche Molecular Systems, Inc.

Saliva Diagnostic Systems, Inc.

LIST OF EXHIBITS

Exhibit 3.1 Lateral Flow Device Scheme

Exhibit 3.2 Flow-Through Device Scheme.

Exhibit 3.3 CANARY™ Biosensor Detection of Viral Pathogens.

Exhibit 3.4 The Principle of the Polymerase Chain Reaction (PCR)

Exhibit 3.5 The TaqMan Principle

Exhibit 4.1 FDA-Approved Rapid HIV Test Kits

Exhibit 4.2 Performance Characteristics of FDA-Approved Rapid HIV Tests Compared to a Typical FDA-Approved Immunoassay under Various Conditions of HIV Prevalence

Exhibit 4.3 The OraQuick Test

Exhibit 4.4 The BioRad Multi-Spot Rapid HIV-1/HIV-2 Test

Exhibit 4.5 The Trinity Biotech Uni-Gold Recombigen HIV Assay

Exhibit 4.6 Selected Internationally Available Rapid HIV Antibody Tests without FDA Approval

Exhibit 4.7 Typical Serological Time Profile in Uncomplicated Hepatitis B

Exhibit 4.8 Selected Internationally Available Rapid Hepatitis B Tests

Exhibit 4.9 Transmission Routes for Hepatitis C Virus

Exhibit 4.10 Estimated and Acute Cases of HCV Infection, USA 1982-2001

Exhibit 4.11 Selected Internationally Available Rapid Hepatitis C Tests

Exhibit 4.12 Performance Characteristics of Rapid Influenza Assays available in the United States (as per manufacturer data)

Exhibit 4.13 Distribution of Dengue Fever, 2000

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

Abstract

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