The Immunoassay Handbook, 4th Edition

Theory and Applications of Ligand Binding, ELISA and Related Techniques

 
The Immunoassay Handbook, 4th Edition,David Wild,ISBN9780080970370
 
 
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D Wild   

Elsevier Science

9780080970370

9780080970387

1036

276 X 216

Provides an excellent revised guide to this commercially highly successful technology in diagnostics and research, from consumer home pregnancy kits to AIDS testing. Please see www.immunoassayhandbook.com for a free downloadable chapter (Immunoassay For Beginners), and access to chapter abstracts, keywords, contributor biographies, and updates

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Key Features

  • Provides a unique mix of theory, practical advice and applications, with numerous examples
  • Offers explanations of technologies under development and practical insider tips that are sometimes omitted from scientific papers
  • Includes a comprehensive troubleshooting guide, useful for solving problems and improving assay performancee
  • Provides valuable chapter updates, now available on www.immunoassayhandbook.com

Description

The fourth edition of The Immunoassay Handbook provides an excellent, thoroughly updated guide to the science, technology and applications of ELISA and other immunoassays, including a wealth of practical advice. It encompasses a wide range of methods and gives an insight into the latest developments and applications in clinical and veterinary practice and in pharmaceutical and life science research.

Highly illustrated and clearly written, this award-winning reference work provides an excellent guide to this fast-growing field. Revised and extensively updated, with over 30% new material and 77 chapters, it reveals the underlying common principles and simplifies an abundance of innovation.

The Immunoassay Handbook reviews a wide range of topics, now including lateral flow, microsphere multiplex assays, immunohistochemistry, practical ELISA development, assay interferences, pharmaceutical applications, qualitative immunoassays, antibody detection and lab-on-a-chip.

This handbook is a must-read for all who use immunoassay as a tool, including clinicians, clinical and veterinary chemists, biochemists, food technologists, environmental scientists, and students and researchers in medicine, immunology and proteomics. It is an essential reference for the immunoassay industry.

Provides an excellent revised guide to this commercially highly successful technology in diagnostics and research, from consumer home pregnancy kits to AIDS testing.

www.immunoassayhandbook.com is a great resource that we put a lot of effort into. The content is designed to encourage purchases of single chapters or the entire book.

David Wild is a healthcare industry veteran, with experience in biotechnology, pharmaceuticals, medical devices and immunodiagnostics, which remains his passion. He worked for Amersham, Eastman-Kodak, Johnson & Johnson, and Bristol-Myers Squibb, and consulted for diagnostics and biotechnology companies. He led research and development programs, design and construction of chemical and biotechnology plants, and integration of acquired companies. Director-level positions included Research and Development, Design Engineering, Operations and Strategy, for billion dollar businesses. He retired from full-time work in 2012 to focus on his role as Editor of The Immunoassay Handbook, and advises on product development, manufacturing and marketing.

Readership

Laboratory researchers and academics who use immunoassay as a tool including pathologists, clinical and veterinary chemists, biochemists, students and researchers in immunology, biochemistry and medicine.

David Wild

David Wild is a healthcare industry veteran, with experience in biotechnology, pharmaceuticals, medical devices and immunodiagnostics, which remains his passion. He worked for Amersham, Eastman-Kodak, Johnson & Johnson, and Bristol-Myers Squibb, and consulted for diagnostics and biotechnology companies. He led research and development programs, design and construction of chemical and biotechnology plants, and integration of acquired companies. Director-level positions included Research and Development, Design Engineering, Operations and Strategy, for billion dollar businesses. He retired from full-time work in 2012 to focus on his role as Editor of The Immunoassay Handbook, and advises on product development, manufacturing and marketing.

Affiliations and Expertise

Healthcare Industry Consultant, previously at Amersham International, Eastman Kodak, Johnson & Johnson and Bristol-Myers Squibb

The Immunoassay Handbook, 4th Edition

Foreword

Preface

Acknowledgements

List of Contributors

About the Editors

Part 1: Immunoassay Fundamentals

Chapter 1.1. How to Use This Book

Using the Index

Book Structure

Chapter 1.2. Immunoassay for Beginners

Immunometric Immunoassays

Competitive Immunoassays

Homogeneous Immunoassays

Calibration

Conclusion

Chapter 1.3. Immunoassay Performance Measures

Assay Sensitivity

Precision and Imprecision

Specificity and Cross-Reactivity

Accuracy and Bias

References

Part 2: Immunoassay Configurations

Chapter 2.1. Principles of Competitive and Immunometric Assays (Including ELISA)1

Kinetics of Antibody–Antigen Interactions

Immunoassay Design

References

Further Reading

Recent References (Examples)

Chapter 2.2. Non-competitive Immunoassays for Small Molecules—the Anti-complex and Selective Antibody Systems

Introduction

The Anti-complex Assay

Selective Antibody Immunometric Assay

The Universal Selective Antibody System

Conclusions

Acknowledgements

References and Further Reading

Chapter 2.3. Homogeneous Immunoassays

Particle Agglutination

Lysis Immunoassays

Spin Immunoassays

Fluorescence Immunoassays

Chemi- and Bioluminescent Immunoassays

Surface-Enhanced Raman Scattering

Enzyme Immunoassays

Enzyme Effector Immunoassays

Proximity-Induced Hybridization

Isotopic Labels

Electroactive Labels

Oxygen-Channeling Immunoassays

Conclusion

References and Further Reading

Chapter 2.4. Lateral Flow Immunoassay Systems: Evolution from the Current State of the Art to the Next Generation of Highly Sensitive, Quantitative Rapid Assays

Brief Overview of Lateral Flow – Current Market Scope and Standard Technology

Evolving Future Performance in POC Diagnostics

Conclusions: Future Directions for Lateral Flow

References and Further Reading

Chapter 2.5. Ambient Analyte Assay

Introduction

Basic Theoretical Principles

Applications of the Ambient Analyte Assay Principle

Summary and Conclusion

References and Further Reading

Chapter 2.6. Free Analyte Immunoassay

Basic Principles Governing the Free Hormone Concentration

Calculation of Free Analyte Concentration

Spreadsheet for Calculation of Free Analyte Concentration

Effect of Serum Proteins on Free Analyte Concentration

In Vitro Measurement of Free Analyte Concentration

Concluding Remarks

References and Further Reading

Chapter 2.7. Qualitative Immunoassay—Features and Design

Features of Qualitative Immunoassay

Qualitative Assay Design and Development

Conclusion

References and Further Reading

Chapter 2.8. Detection of Antibodies Relevant to Infectious Disease

Assay Formats

Assay Development

Assay Validation

Instrumentation

Applications

Further Reading

Chapter 2.9. Microsphere-Based Multiplex Immunoassays: Development and Applications Using Luminex® xMAP® Technology

xMAP Technology

xMAP Microspheres

Luminex Analyzers

Assay Development

Immunoassay Formats

Commercial Immunoassay Applications and Platforms

Conclusions

References

Chapter 2.10. Lab-on-a-Chip, Micro- and Nanoscale Immunoassay Systems, and Microarrays

Fundamentals of Miniaturization

Immunoassay Design at Micro- and Nanoscale

Immunodiagnostic Markers in Microfluidic Devices

Enabling Microfluidic Technologies for Immunodiagnostics

Commercial Microfluidic Immunodiagnostics

Microarrays, Immunoassay, and Proteomics

Conclusions

References

Further Reading

Chapter 2.11. Immunological Biosensors

Overview

Amperometric Sensors

Microcantilever Sensors

Live-Cell Nanomechanical Assays

Conclusions

References

Chapter 2.12. Surface Plasmon Resonance in Binding Site, Kinetic, and Concentration Analyses

Protein Interactions in Basic and Applied Research

SPR Biosensors

Binding Site Analysis—Epitope Mapping

Kinetic Analysis

Concentration Analysis

Summary and Acknowledgments

References

Chapter 2.13. Measurement of Single Protein Molecules Using Digital ELISA

The Digital ELISA Approach

Analytical Sensitivity and Dynamic Range

Theoretical Considerations

Assay Development

Instrumentation

Applications

Future

References and Further Reading

Part 3: Immunoassay Components

Chapter 3.1. Antibodies

Antibody Structure

The Antibody Response In Vivo

Antibody Diversity

Immunization

Polyclonal Antisera

Monoclonal Antibodies

Antibody Fragments

Bispecific Antibodies

Chimeric and Humanized Antibodies

Recombinant Antibodies

Antibody Conjugates and Fusion Proteins in Diagnostics

Antibodies in Nanotechnology

Polyclonal, Monoclonal, or Recombinant?

References and Further Reading

Chapter 3.2. Signal Generation and Detection Systems (Excluding Homogeneous Assays)

Radioactive Labels

Enzyme Labels

Direct Fluorescence

Time-Resolved Fluorescence

Direct Chemiluminescence

Bioluminescence

Phosphorescence

Micro and Nanoparticle Labels

Streptavidin/Avidin–Biotin

Protein A

Amplification Strategies

Multiple Analytes and Miniaturization

Conclusion

Reference and Further Reading

Chapter 3.3. Separation Systems

Surface-Coated Solid Phases

Washing

Liquid-Phase Separations

Microarray Immunoassay Separation

References and Further Reading

Chapter 3.4. Conjugation Methods

Categories of Conjugates Employed in Immunoassay

Protein–Protein Coupling

Protein-Small Molecule Coupling

Purification of Conjugates

Characterization of Conjugates

Conclusion

References and Further Reading

Chapter 3.5. Standardization and Calibration

Standardization

Calibration

References and Further Reading

References Containing Discussions About Standardization

Chapter 3.6. Calibration Curve Fitting

Response Transformations

Determining the Response–Error Relationship

Curve-Fitting Methods

Error Profiles

Outliers

Stored Calibration Curves, Factory Master Curves, and Adjusters

Suitable Calibration Curve-Fit Software

References and Further Reading

Part 4: Related Techniques

Chapter 4.1. The Foundations of Immunochemistry

Introduction

The Immunological Reaction (1895–1935)

Qualification by Diffusion in Gel (1861–1977)

Qualitative Analysis by Immunoelectrophoresis (1953–1978)

Quantification of Antigens by In-Gel Immunochemistry (1963–Present)

Quantification of Antigens by In-Liquid Immunochemistry (1935–Present)

Quantification of Antigens by Particle Enhanced Immunochemistry (1972–Present)

Labeled Immunoassay (1959–Present)

Comparative Studies (1907–Present)

Acknowledgments

References

Futher Reading

Chapter 4.2. Immunohistochemistry and Immunocytochemistry

Specimen Formats for Immunochemistry

Fixation

Processing Tissue Blocks to Paraffin Wax

Microtomy

Tissue Microarrays

Specimen Storage

Decalcification

Antigen Retrieval

Controls

Immunochemical Staining Techniques (Optimizing a New Antibody)

Counterstains

Mounting

Examples of Immunostaining Photomicrographs

Acknowledgements

References and Further Reading

Part 5: Immunoassay Development

Chapter 5.1. Practical Guide to ELISA Development

Fundamental Requirements

Key Steps of ELISA Development

Separation and Washing

Signal Generation and Detection

Assay Optimization

Hardware and Software

Assay Management

ELISA Tips and Troubleshooting

Conclusions

References and Further Reading

Chapter 5.2. Method Evaluation—A Practical Guide

Assay Groups

Initial Screen Using Available Information

Cost-Effective Initial Test Evaluation

Evaluation against Current Method Using Clinical Samples

Final Evaluation Tests

Suggested Format of Evaluation Report

Useful Guidelines

References and Further Reading

Chapter 5.3. Interferences in Immunoassay

Scope of Immunoassay Interferences

Strategies to Identify Potential Cases of Assay Interference

Strategies to Prove the Presence of Interference

Measures to Prevent Immunoassay Interference and Existing Regulatory Guidelines

Clinical Consequences of Immunoassay Interference

Summary

References

Chapter 5.4. Immunoassay Development in the In Vitro Diagnostic Industry

Assay Design Overview

Experimental Design in Immunoassay Development

Four Key Assay Design Principles

Conclusion

Further Reading

Part 6: Immunoassay Implementation

Chapter 6.1. Sample Collection, Including Participant Preparation and Sample Handling

Participant State and Preparation

Timing

Blood Collection by Venepuncture

Interference by Tube and Stopper Components

The Use of Serum Separators

Collection of Blood by Skin Puncture

Urine Collection

Oral Fluid

Cerebrospinal Fluid

Amniotic Fluid

Sweat

Semen

Hair

Milk

Storage and Transportation

Conclusions

Author Notes

Further Reading

Chapter 6.2. Quality Assurance

Pre-analytical Quality Requirements

IQC and EQA as Tools for Assessing Quality

Internal Quality Control

External Quality Assessment

Conclusions

Sample Statistical Packages for IQC

References and Further Reading

Chapter 6.3. Point-of-Care Testing

Delivery Options

Quality Assurance

Practical Management

Summary

References and Further Reading

Chapter 6.4. Choosing an Automated Immunoassay System

Defining Automation Goals

Sources of Information

Considerations and Criteria

Summary

Further Reading

Chapter 6.5. Immunoassay Troubleshooting Guide

Instructions

Troubleshooting Guide

Part 7: Immunoassay Product Technology

Chapter 7.1. Introduction to Immunoassay Product Technology in Clinical Diagnostic Testing

Immunoassay Product Technologies

Acknowledgments

References and Further Reading

Chapter 7.2. Market Trends

Immunoassay Market Status

Established Trends

The Future of the Immunodiagnostics Business

Conclusion

Summary of Likely Trends in Immunodiagnostics and Related Products

Chapter 7.3. Lateral Flow and Consumer Diagnostics

Pregnancy Tests

Ovulation Tests

Digital Interface

Conclusions

References

Chapter 7.4. Consumer Diagnostics—Clearblue Pregnancy and Fertility Testing

Clearblue Pregnancy Tests

Clearblue Ovulation Test

Clearblue Fertility Monitor

Persona

References and Further Reading

Chapter 7.5. The Triage® System

User Protocol

Product Features

Assay Principle

Multianalyte Measurements

Calibration

Antibodies

Quality Control

Data Processing

Triage Symptom-Based Diagnostic Panels

References and Further Reading

Chapter 7.6. Stratus® CS Acute Care™ STAT Fluorometric Analyzer

Typical Assay Protocol

Product Features

Assay Principle

Calibration

Antibodies

Separation

Signal Generation and Detection

Data Processing

Further Reading

Chapter 7.7. IMx®1

Typical Assay Protocol

Product Features

Assay Principle

Calibration

Antibodies

Separation

Signal Generation and Detection

Data Processing

Interfacing to Laboratory Information Systems

References and Further Reading

Chapter 7.8. AxSYM®

Typical Assay Protocol

Product Features

Assay Principle

Calibration

Antibodies

Separation

Signal Generation and Detection

Data Processing

Interfacing to Laboratory Information Systems

Further reading

Chapter 7.9. Abbott ARCHITECT® Family of Analyzers

Typical Assay Protocols

Product Features

Assay Principle

Calibration

Antibodies

Separation

Signal Generation and Detection

Informatics, Data Processing, and Laboratory Information Systems (LIS)

Further Reading

Chapter 7.10. ADVIA Centaur® XP

Typical Assay Protocol

Product Features

Assay Principle

AE Enhancement Features

Calibration

Antibodies

Separation

Signal Generation and Detection

Data Processing

User Interface

Interfacing to Laboratory Information Systems

Further Reading

Chapter 7.11. IMMULITE® and IMMULITE 1000

Typical Assay Protocol

Product Features

Assay Principle

Calibration

Antibodies

Separation

Signal Generation and Detection

Data Processing

Interfacing to Laboratory Information System

Further Reading

Chapter 7.12. IMMULITE® 2000 and IMMULITE 2000 XPi

Typical Assay Protocol

Product Features

Assay Principle

Calibration

Antibodies

Separation

Signal Generation and Detection

Data Processing

Interfacing to Laboratory Information System

Chapter 7.13. VITROS® ECiQ Immunodiagnostic System, VITROS® 3600 Immunodiagnostic System, and VITROS® 5600 Integrated System

Typical Assay Protocol

Product Features

Assay Principle

Calibration

Antibodies

Separation

Signal Generation and Detection

Data Processing

Interfacing to Laboratory Information Systems

Further Reading

Chapter 7.14. VITROS® Immuno-Rate and MicroTip™ Assays

Typical Assay Protocols

Product Features

Assay Principle

Calibration

Antibodies

Separation

Signal Generation and Detection

Data Processing

Interfacing to Laboratory Information Systems

Further Reading

Chapter 7.15. Access 2

Typical Assay Protocol

Product Features

Assay Principle

Antibodies

Calibration

Separation

Signal Generation and Detection

Data Processing

Interfacing to Laboratory Information Systems

Further Reading

Chapter 7.16. DxI 600 and DxI 800

Typical Assay Protocol

Product Features

Assay Principle

Calibration

Antibodies

Separation

Signal Generation and Detection

Data Processing

Interfacing to Laboratory Information Systems

Further Reading

Chapter 7.17. Elecsys® Immunoassay Systems

Typical Assay Protocol

Product Features

Assay Principle

Calibration

Antibodies

Separation

Signal Generation and Detection

Data Processing

Interfacing with LISs

References and Further Reading

Chapter 7.18. PRISM™

Typical Assay Protocol

Product Features

Assay Principle

Calibration

Biologic Reagents

Separation

Signal Generation and Detection

Data Processing

Interfacing to Laboratory Information Systems

References and Further Reading

Chapter 7.19. Phadia Laboratory Systems

Typical Assay Protocol

Assay Principle

Signal Generation and Detection

Data Processing

Part 8: Immunoassay Applications Other Than Clinical Chemistry

Chapter 8.1. Immunoassay Applications in Veterinary Diagnostics

Infectious Disease Diagnosis/Assessment of Immune Status

Assessment of Reproductive/Metabolic Status

Conclusion

References

Chapter 8.2. Ligand Binding Assays in Drug Development

Basic Research

Application of LBAs in Nonclinical Drug Development

Clinical Phase

References

Part 9: Immunoassay Clinical Applications (Human)

Chapter 9.1. Clinical Concepts

Diagnosis

Reference Interval

Clinical Sensitivity and Specificity

Positive and Negative Predictive Values

Prevalence and Clinical Utility

Likelihood Ratio

Continuous Measurement, ROC Curves

Confidence Interval Analysis of Clinical Performance

Probabilistic Interpretation of Test Results

Analytical Goals

Summary

References

Further reading

Chapter 9.2. Thyroid

Normal Thyroid Function

Clinical Disorders

Analytes

Thyroid Testing Strategies

References and Further Reading

Websites

Chapter 9.3. The Adrenal Cortex

Normal Adrenocortical Function

Clinical Disorders

Analytes

Management of Patients with Cushing’s Syndrome

Further Reading

Chapter 9.4. Bone and Calcium Metabolism

Normal Calcium Metabolism

Clinical Disorders

Analytes

Biochemical Markers of Bone Turnover

Summary of Changes in Hormones and Bone Markers in Conditions Associated with Abnormal Calcium and Bone Metabolism

References and Further Reading

Chapter 9.5. Infertility

Clinical Disorders

Analytes

Test Strategy for Infertility in Women

Acknowledgment

References and Further Reading

Chapter 9.6. In Vitro Fertilization and Embryo Transfer (IVF-ET)

Historical Perspective

The IVF Programme

Embryo Transfer in the Fresh IVF Cycle

Analytes

References and Further Reading

Chapter 9.7. Hirsutism and Virilization in the Female

Clinical Disorders

Analytes

Further Reading

Chapter 9.8. Pregnancy

Clinical Conditions and Disorders

Analytes

Screening for Aneuploidy

Further Reading

Chapter 9.9. Growth and Growth Hormone Deficiency

Normal Childhood Growth

Clinical Disorders

Analytes

General Strategy

Further Reading

Chapter 9.10. Diabetes Mellitus

Analytes

References and Further Reading

Chapter 9.11. Hematology

Normal Blood Function

Clinical Disorders

Analytes

Thrombosis and Hemostasis

Thrombophilia

Coagulation

Evidence of Disseminated Intravascular Coagulation (DIC)

Immunodetection Methods

Malarial Parasites

Hemoglobinopathies

References and Further Reading

Chapter 9.12. Cardiac Markers

Normal Heart Function

Clinical Disorders

Analytes

References and Further Reading

Chapter 9.13. Cancer Markers

Introduction

History and Classification

Analytes

Novel Experimental and Other Minor Markers

References and Further Reading

Chapter 9.14. Allergy

Allergic Disease

Analytes

Standardization and Evaluation

Clinical Applications

References and Further Reading

Chapter 9.15. Autoimmune Disease

Analytes

References and Further Reading

Chapter 9.16. Gastrointestinal Tract

Normal Gastrointestinal Function

Neuroendocrine Tumors

Chapter 9.17. Hepatitis

Hepatitis A Virus

Hepatitis B Virus

Hepatitis C Virus

Hepatitis D Virus

Hepatitis E Virus

Further Reading

Chapter 9.18. HIV-1 and HIV-2: Causative Agents of AIDS

Etiologic Agent

Pathogenesis

Diagnosis of HIV Infection

Therapeutic Monitoring

Summary

References and Further Reading

Chapter 9.19. Viral Diseases1

Cytomegalovirus (CMV)

Epstein-Barr Virus (EBV)

Herpes Simplex Virus (HSV)

Dengue

Rubella

Measles, Mumps, and Varicella

Human T-Cell Leukemia Virus (HTLV)

Parvovirus B19

West Nile Virus

Rotavirus

Adenovirus

Chapter 9.20. Bacterial Diseases1

Streptococcus pyogenes

Syphilis

Borrelia

Helicobacter pylori

Shiga-Toxin Producing Escherichia coli

Legionella

Bartonella henselae

Leptospira

Coxiella

Brucella

Francisella tularensis

Chapter 9.21. Parasites and Fungi

Parasites

Chagas Disease

Trichomonas vaginalis

Malaria

Cryptosporidium and Giardia

Strongyloides

Fungi

Candida

Endemic Mycoses

Chapter 9.22. Therapeutic Drug Monitoring (TDM)

Assay Technology

Measurement of Free Drug Concentration

Practical Aspects of TDM

Antiarrhythmic Agents

Drugs Acting on the Respiratory System

Antibiotics

Anticonvulsants

Drugs for Malignancy and Immunosuppression

Miscellaneous

References and Further Reading

Chapter 9.23. Drugs of Abuse

Applications

Immunoassays for Drugs of Abuse

Legal Addictive Substances

Steroid Abuse in Sport

Rapid Immunoassay Tests for Drugs of Abuse

References and Further Reading

Index

Quotes and reviews

"The beauty of this book is that it covers the whole field of immunoassay from reagents to method development, interferences and applications…The fourth edition does not disappoint. It is an essential reference manual for staff using immunoassays and to students in the field of laboratory medicine and other science disciplines." --Annals of Clinical Biochemistry, November 2013

"The book starts out very basic with principles of immunoassays (‘immunoassays for beginners’) and builds progressively to discuss immunoassay components, configurations, development, implementation, product technology, applications other than clinical chemistry, and concludes with 23 chapters on clinical applications to human disease…This is the single ‘go-to’ book for any questions regarding immunoassays. If this is an area of interest for you, you must have this edition." --Doody.com, November 2013

"Editors Wild, John, Sheehan, Binder, and He present this handbook on the highly sensitive technique of immunoassay…Equations, figures, and real-world examples are used to clarify mechanisms and analysis. The range of detail makes it appropriate as both a pedagogical resource and a reference for immunology labs." --Reference and Research Book News, October 2013

"...it must be stated that there is much of value in the volume [2nd Ed.]. It is a useful and informative addition to any scientific library." --Robert F. Ritchie, Foundation for Blood Research, Scarborough, USA

 
 
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