The Immunoassay Handbook

The Immunoassay Handbook

Theory and Applications of Ligand Binding, ELISA and Related Techniques

4th Edition - January 21, 2013

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  • Editor: David Wild
  • eBook ISBN: 9780080970387
  • Hardcover ISBN: 9780080970370

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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.

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

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

Table of Contents

  • 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

Product details

  • No. of pages: 1036
  • Language: English
  • Copyright: © Elsevier Science 2013
  • Published: January 21, 2013
  • Imprint: Elsevier Science
  • eBook ISBN: 9780080970387
  • Hardcover ISBN: 9780080970370

About the Editor

David Wild

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

Ratings and Reviews

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  • MIGUEL B. Wed May 16 2018

    Dense but helpful

    Dense but helpful

  • Noreen M. Fri Mar 16 2018

    Excellent book!

    Well written, easy to understand and very useful book.