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The fourth edition of The Immunoassay Handbook provides an excellent, thoroughly updated guide to the science, technology and applications of ELISA and other immunoass… Read more
LIMITED OFFER
Immediately download your ebook while waiting for your print delivery. No promo code needed.
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.
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
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