Handbook of Immunoassay Technologies: Approaches, Performances, and Applications

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Handbook of Immunoassay Technologies: Approaches, Performances, and Applications unravels the role of immunoassays in the biochemical sciences. During the last four decades, a wide range of immunoassays has been developed, ranging from the conventional enzyme-linked immunosorbent assays, to the smartphone-based point-of-care formats. The advances in rapid biochemical procedures, novel biosensing schemes, fully integrated lab-on-a-chip platforms, prolonged biomolecular storage strategies, device miniaturization and interfacing, and emerging smart system technologies equipped with personalized mobile healthcare tools are paving the way to next-generation immunoassays, and are all discussed in this comprehensive text. Immunoassays play a prominent role in clinical diagnostics as they are the eyes of healthcare professionals, helping them make informed clinical decisions via confirmed disease diagnosis, and thus enabling favorable health outcomes. The faster and reliable diagnosis of infections will further control their spread to uninfected persons. Similarly, immunoassays play a prominent role in veterinary diagnostics, food analysis, environmental monitoring, defense and security, and other bioanalytical settings. Therefore, they enable the detection of a plethora of analytes, which includes disease biomarkers, pathogens, drug impurities, environmental contaminants, allergens, food adulterants, drugs of abuse and various biomolecules. Cover Handbook of Immunoassay Technologies: Approaches, Performances, and Applications Copyright Contents Contributors Preface Objectives of the Book Scope of the Book Target Audience Book Organization 1. Immunoassays: An Overview 1. Overview of Immunoassays 2. Antibody Structure 3. Need for Immunoassays 3.1 Clinical 3.2 Industrial 3.3 Environment and Security 3.4 Food 3.5 Personalized Healthcare 4. Immunoassay Formats 5. Conclusions and Future Trends References 2. Antibody Immobilization and Surface Functionalization Chemistries for Immunodiagnostics 1. Introduction 2. Surface Functionalization Chemistries 2.1 Hydroxyl Groups 2.2 Amino Groups 2.3 Carboxyl Groups 2.4 Sulfhydryl Groups 2.5 Epoxy Groups 3. Antibody Immobilization Chemistries 3.1 Covalent 3.2 Oriented 3.3 Noncovalent 3.3.1 Adsorption 3.3.2 Affinity 3.4 Site-Specific 3.5 Peptide Nucleic Acid and Deoxyribonucleic Acid–Directed 3.6 Recombinant Antibody 4. Surface Characterization 5. Conclusions, Challenges, and Future Trends References 3. Monoclonal Antibody Generation by Phage Display: History, State-of-the-Art, and Future 1. Introduction 1.1 History of the Development of Antibody Phage Display 1.2 Antibody Formats Used for Phage Display 1.3 Further Recombinant Antibody Formats 2. Phage Display Selection 2.1 Advantages of Recombinant Antibody Selection 2.2 Guided Selection 2.3 Affinity Improvement 2.4 Other Selection Technologies 3. Antibody Libraries 3.1 Immune Libraries 3.2 Naïve Natural Libraries 3.3 Naïve Semisynthetic Libraries 3.4 Naïve Synthetic Libraries 3.5 Special Library Designs 3.6 Synthetic Libraries From Nonhuman Species 4. In Vitro Selection of Antibodies for Specific Applications 4.1 Tissue Panning for Immunohistochemistry Antibodies 4.2 Sandwich Pair Selection, Complex-Specific Antibodies, and Drug Monitoring 4.3 Fully Human Controls in Diagnostic Immunoassays 4.4 Site-Specific Conjugation 5. Conclusion and Outlook 5.1 Future References 4. Bioanalytical Requirements and Regulatory Guidelines for Immunoassays 1. Introduction 2. Bioanalytical Requirements for an Immunoassay 2.1 Accuracy 2.2 Precision 2.3 Selectivity 2.4 Sensitivity 2.5 Reproducibility 2.6 Stability 2.7 Recovery 2.8 Calibration Curve 2.9 Bioanalytical Performance Parameters 2.9.1 Limit of Blank 2.9.2 Limit of Detection 2.9.3 Limit of Quantification 2.9.4 Lower Limit of the Linear Interval 2.9.5 Lower Limit of the Measuring Interval 2.9.6 Errors 2.9.7 Carryover 2.9.8 Interference 2.9.9 Quality Controls 2.9.10 Linear Range 2.9.11 Analytical Measurement Range 2.9.12 Clinically Reportable Range 2.9.13 Bias 2.9.14 Hook Effect 2.9.15 Method Comparison 2.9.16 Cross-reactivity 3. Critiques and Outlook 4. Conclusions References 5. Enzyme-Linked Immunoassays 1. Introduction 2. Conventional Enzyme-Linked Immunoassays 2.1 Enzyme-Linked Immunosorbent Assay 2.1.1 Direct Enzyme-Linked Immunosorbent Assay 2.1.2 Indirect Enzyme-Linked Immunosorbent Assay 2.1.3 Sandwich Enzyme-Linked Immunosorbent Assay 2.2 Competitive Enzyme-Linked Immunoassay 3. Emerging Enzyme-Linked Immunoassays 3.1 High-Sensitivity Sandwich Enzyme-Linked Immunoassay 3.2 Highly Simplified Rapid Sandwich Enzyme-Linked Immunoassay 3.3 Wash-Free Immunoassays 3.4 Multiplex Immunoassays 3.5 Nano/Micromaterial-Based Enzyme-Linked Immunoassay 3.6 Paper-Based Enzyme-Linked Immunoassay 3.7 Microfluidics-Based Enzyme-Linked Immunoassay 3.7.1 Optimiser Enzyme-Linked Immunosorbent Assay 3.7.2 Centrifugal Microfluidics-Based Immunoassay 3.8 Smartphone-Based Enzyme-Linked Immunoassay 4. Portable Analyzer–Based Immunoassays 5. Critiques and Outlook 6. Conclusions References 6. Surface Plasmon Resonance–Based Immunoassays: Approaches, Performance, and Applications 1. Introduction 1.1 Surface Plasmon Resonance 1.2 Surface Plasmon Resonance Principles 1.3 Surface Plasmon Resonance–Based Biosensor Platforms 2. Surface Plasmon Resonance–Based Immunoassays 2.1 Antibody Introduction 2.2 Antibody Screening Using Surface Plasmon Resonance 2.3 Surface Plasmon Resonance Immunoassay Introduction 2.3.1 Small Molecular Weight Targets 2.3.2 Pathogens and Viruses 2.3.3 Disease Targets 3. Future Trends in Surface Plasmon Resonance–Based Immunoassays 3.1 Surface Plasmon Resonance–Mass Spectrometry 3.2 Surface Plasmon Resonance–Point-of-Care Applications 3.2.1 CD-Based Surface Plasmon Resonance 3.2.2 Mobile Phone-Surface Plasmon Resonance 4. Conclusions Acknowledgments References 7. Lateral Flow Immunoassays 1. Introduction 1.1 Lateral Flow Immunoassays 1.1.1 History of the Technology 1.1.2 Basic Technology 1.1.3 Recognition Elements 1.1.4 Signal Labels 1.1.5 Storage of Lateral Flow Devices 2. Advances in Lateral Flow Immunoassays 2.1 Coupling to a Range of Detection Principles 2.2 Multianalyte and Quantitative Lateral Flow Immunoassays 2.3 Reading MultiSpot Lateral Flow Assays 2.3.1 Lateral Flow Reader for Microarrays 2.3.2 Real-Time Video Reader 2.3.3 Reading Arrays by a Smartphone Application 3. Challenges and Future Directions 3.1 Updated SWOT Analysis 3.1.1 Weaknesses 3.1.2 Opportunities 3.1.3 Threats 3.2 Combination With Amplification Procedures 3.3 Integration of Lateral Flow Immunoassays With Paper Diagnostics 4. Bibliographic and Commercial Data 5. Conclusions References 8. Paper-Based Immunoassays 1. Paper-Based Immunoassays: Strategies and Detection Principles 1.1 Colorimetric Method 1.1.1 AuNPs 1.1.2 Enzymes 1.1.3 Carbon Nanoparticles 1.1.4 Magnetic Nanoparticles 1.2 Thermal Method 1.3 Electrochemical Method 1.4 Magnetic Method 2. Development of the Paper-Based Immunoassays Devices 2.1 Sensitivity Improvement 2.2 Automatic Detections 2.3 Semiquantification Detection and Quantification Detection 3. Conclusions References 9. Acoustic Wave–Based Immunoassays 1. Introduction 2. Clinical Diagnostics 2.1 Quartz Crystal Microbalance Immunosensors 2.1.1 Direct Immunosensors 2.1.2 Indirect Immunosensors 2.1.3 Sandwich-Amplified Immunosensors 2.2 Surface Acoustic Wave Immunosensors 2.2.1 Direct Immunosensors 3. Detection of Microbial Pathogens and Toxins 3.1 Quartz Crystal Microbalance Immunosensors 3.1.1 Direct Immunosensors 3.1.2 Indirect Immunosensors 3.1.3 Sandwich-Amplified Immunosensors 3.2 Surface Acoustic Wave Immunosensors 3.2.1 Direct Immunosensors 3.2.2 Sandwich-Amplified Immunosensors 4. Detection of Parasites 4.1 Quartz Crystal Microbalance Immunosensors 4.1.1 Direct Immunosensors 4.1.2 Indirect Immunosensors 4.1.3 Sandwich-Amplified Immunosensors 5. Detection of Viruses 5.1 Quartz Crystal Microbalance Immunosensors 5.1.1 Direct Immunosensors 5.1.2 Indirect Immunosensors 5.1.3 Sandwich-Amplified Immunosensors 5.2 Surface Acoustic Wave Immunosensors 6. Quartz Crystal Microbalance and Surface Acoustic Wave-Based Electronic Noses 7. Quartz Crystal Microbalance and Surface Acoustic Wave Immunoassays in Environmental Monitoring and Allergens Detection 8. Integrated Acoustic Wave Immunosensors for Point of Care 9. Commercial Acoustic Wave Immunosensors 10. Market Potential and Conclusions Acknowledgments References 10. Interferometry-Based Immunoassays 1. Introduction: General Context 2. Principles of Operation 2.1 Label-Free Optical Sensing 2.2 Interferometric Sensors 3. Sensor Surface Functionalization 3.1 Chemical Activation of Transducers 3.2 Immobilization of Recognition Molecules 3.3 Elimination of Nonspecific Binding 4. Application of Interferometric Immunosensors 4.1 Mach–Zehnder Interferometers 4.2 Young Interferometers 4.3 Bimodal Interferometers 5. Conclusions and Future Perspectives References 11. Nanomaterial- and Micromaterial-Based Immunoassays 1. Introduction 2. Micromaterial-Based Immunoassay 2.1 Fluorescent Polystyrene Microsphere 2.2 Magnetic Microbeads 2.3 Nanomaterial-Based Immunoassay 3. Colorimetric Immunoassay 3.1 Lateral Flow Assay 3.2 Plate-Based Colorimetric Immunoassay 4. Electrochemical Immunoassay 5. Fluorescent Immunoassay 5.1 Heterogeneous Immunoassay 5.2 Fluorescence Resonance Energy Transfer Assay 6. Conclusion References 12. Microcantilever-Based Sensors 1. Introduction 2. Microcantilevers and Their Modes of Operation 2.1 Operating Modes for Cantilever Mass Sensors 3. Detection Methods 3.1 Optical 3.2 Piezoresistive 3.3 Capacitive 3.4 Piezoelectric 3.5 Interferometry 3.6 Optical Diffraction Grating 3.7 Charge-Coupled Device 4. Bending Behavior of Microcantilevers 5. Fabrication of Microcantilevers 6. Microcantilever-Based Sensors 6.1 Detection of Biomolecules 6.1.1 DNA 6.1.2 Prostate-Specific Antigen 6.1.3 Myoglobin 6.1.4 Lipoproteins 6.1.5 Glucose 6.1.6 Tributyrin 6.2 Detection of Gaseous Analytes 6.3 Detection of Chemicals and Metal Ions 6.4 Detection of Humidity and pH 6.5 Detection of Explosives and Monitoring of Ammunition 7. Electronic Nose 8. Nanocantilevers 9. Commercial Availability 10. Conclusions and Future Trends References 13. Quartz Crystal Microbalance–Based Sensors 1. Introduction 2. Detection of Biomolecules 3. Detection of Bacteria 4. Detection of Volatile Organic Compounds 5. Detection of Chemical Analytes 6. Detection of Gaseous Analytes 7. Special Analytical Applications 8. Other Analytical Applications 9. Conclusions and Future Trends References 14. Electrochemical Immunosensors: Fundamentals and Applications in Clinical Diagnostics 1. Introduction 2. Electrochemical Techniques in Immunosensing 2.1 Voltammetry 2.2 Amperometry 2.3 Potentiometry 2.4 Electrochemiluminescence 2.5 Electrochemical Impedance Spectroscopy 2.6 Photoelectrochemical Techniques 3. Advanced Approaches in Electrochemical Immunosensors 3.1 Electrochemical Lateral Flow Assay 3.2 Approaches Based on Receptor–Ligand–Receptor Binding 3.3 Colorimetric Immunosensing Approaches 3.4 Redox Cycling–Based Approaches 4. Biorecognition Elements in Immunosensors 4.1 Antibodies: The Primary Recognition Elements of Immunoassays 4.2 Truncated (Fragmented) Antibodies 4.3 Aptamer–Antibodies Hybrid 5. Electrochemical Immunosensors 5.1 Label-Free Protein-Based Immunosensors 5.2 Bacterial/Cancer Cells–Based Immunosensors 5.3 Enzyme-Labeled Immunosensors 5.4 Redox-Labeled Immunosensors 5.5 Aptamer-Based Immunosensors 6. Conclusions and Outlook Acknowledgments References 15. Lab-on-a-Chip (LOC) Immunoassays 1. Introduction 2. Lab-on-a-Chip Immunoassays 2.1 Microfluidic 2.2 Paper 2.3 Cellphone 3. Critiques and Outlook 4. Conclusions References 16. Smartphone-Based Immunoassays 1. Introduction 2. Signal Detection in Smartphone-Based Immunoassays 2.1 Colorimetric, Fluorescent, and Luminescent Detection 2.2 Electrochemical Detection 2.3 Surface Plasmon Resonance Detection 2.4 Lateral Flow Assays 2.5 Microscopy 2.6 Cytometry 3. Applications of Smartphone-Based Immunoassays 3.1 Detection of Biomolecules and Microorganisms 3.2 Detection of Other Analytes 3.3 Detection of Blood Glucose 4. Conclusions, Challenges, and Future Trends References 17. Immunoassays: Future Prospects and Possibilities 1. Immunoassays: Trends and Prospects 2. Evolving Healthcare 3. Challenges 4. Future Directions References Index A B C D E F G H I K L M N O P Q R S T V W X Y Z Backcover