BioSensing, Theranostics, and Medical Devices: From Laboratory to Point-of-Care Testing

Contents
About the Editors
Chapter 1: Gold Nanoclusters as Emerging Theranostic Interventions for Biomedical Applications
1.1 Introduction
1.2 Synthesis of AuNCs
1.3 Gold Nanoclusters as Biosensors
1.4 Gold Nanoclusters as Therapeutics
1.5 Conclusions and Future Prospects
References
Chapter 2: Advances in Materials, Methods, and Principles of Modern Biosensing Tools
2.1 Introduction
2.2 Materials for Biosensors
2.3 Principles of Biosensing
2.3.1 Colorimetric
2.3.1.1 Liquid Phase Biosensors
2.3.1.2 Paper Biosensors
2.3.1.3 Microfluidic Biosensors
2.3.1.4 Microfluidic Paper Analytical Devices (μPADs)
2.3.2 Colorimetric Assays
2.3.3 Chemiresistive Biosensors
2.3.4 Electrochemical Biosensors
2.3.5 Semiconductor Biosensors
2.4 Recent Trends of Biosensing and Device Fabrication
2.5 Future of Biosensing
2.6 Summary
References
Chapter 3: Evolution Towards Theranostics: Basic Principles
3.1 Introduction
3.2 Basic Principle of Theranostics in POC
3.2.1 Fundamental Prospects
3.2.2 Components
3.2.3 Point-of-Care Devices
3.3 Biological Factors Involved in Theranostic Applications
3.3.1 Administration of Nanoparticles
3.3.1.1 Passive Targeting
3.3.1.2 Active Targeting
3.3.1.3 Physical Targeting
3.3.2 The Journey of Nanoparticles to the Target Sites
3.4 Recent Advancements in Theranostics
3.5 Advantages of Smart Theranostics Agents Over Conventional Therapy
3.5.1 Localized Therapy
3.5.2 Multimodality
3.5.3 Simultaneous Diagnosis and Therapy
3.5.4 Multifunctionality
3.5.5 Real-Time Monitoring
3.5.6 Immune-Evasion
3.6 Challenges for Responsible Development
3.6.1 Toxicity
3.6.2 Stability
3.6.3 Commerciality
3.7 Future Perspective
3.8 Conclusion
References
Chapter 4: Biosensor-Based Point-of-Care Devices: Metabolites and Pulse Oximetry
4.1 Introduction
4.2 Glucose Measurement at the Point-of-Care
4.2.1 Methods of Measurement
4.2.2 Summary of Devices
4.2.2.1 Glucose Meters for At-Home Care
4.2.2.2 Glucose Meters for Clinical Care
4.3 Creatinine Measurement at the Point-of-Care
4.3.1 Methods of Measurement
4.3.2 Summary of Devices
4.4 Lipid Measurement at the Point-of-Care
4.4.1 Mechanisms of Measurement
4.4.2 Summary of Devices
4.5 Pulse Oximetry Measurements at the Point-of-Care
4.5.1 Methods of Measurement
4.5.2 Summary of Devices
4.6 Conclusion
References
Chapter 5: Biosensor-Based Point-of-Care Devices: Detection of Infectious Diseases and Cancer
5.1 Introduction
5.2 Pathogen Detection at the Point-of-Care
5.2.1 Methods of Detection
5.2.2 Summary of Devices
5.2.2.1 HIV
5.2.2.2 Tuberculosis
5.2.2.3 Malaria
5.2.2.4 Syphilis
5.2.2.5 Chlamydia and Gonorrhea
5.3 Cancer Detection at the Point-of-Care
5.3.1 Methods of Detection
5.3.2 Summary of Devices
5.3.2.1 Prostate Cancer
5.3.2.2 Colorectal Cancer
5.3.2.3 Liver Cancer
5.3.2.4 Bladder Cancer
5.4 Conclusion
References
Chapter 6: Non-invasive Cellular Characterization Using Bioimpedance Sensing
6.1 Introduction
6.2 Principle
6.2.1 Cell-Substrate Impedance
6.2.2 Design and Simulation of Sensor Configuration
6.3 Bioimpedance Sensor and Impedance Measurement
6.3.1 Device Fabrication
6.3.2 Cleaning and Surface Modification of the Sensor
6.3.3 Experimental Setup
6.3.4 Cell Culture and Cell Seeding Inside the Chip
6.3.5 Bioimpedance Measurement
6.4 Theoretical Analysis
6.4.1 Electrical Equivalent Model of the System
6.4.1.1 Estimation of Equivalent Model Parameters
6.4.1.2 Fragmental Frequency Analysis Method to Extract the Model Parameters
6.4.2 Extracting the Single Cell Property from Measurement of Group of Cells
6.4.2.1 Maxwell´s Mixture Theory
6.4.2.2 Equivalent Electrical Model of Single Cell
6.5 Applications
6.5.1 Calculation of Equivalent Parameters of HeLa Cells Using Fragmental Frequency Analysis
6.5.1.1 Resistance of the PBS Media
6.5.1.2 Resistance Rexp
6.5.1.3 Coating Capacitance
6.5.1.4 Double Layer Capacitance
6.5.1.5 Equivalent Parameters of the HeLa Cells
6.5.2 Extraction of Single Cell Parameters of HeLa Cells
6.6 Summary
References
Chapter 7: Research Aspects and Strategies for the Development of Biosensors for Renal Disease Diagnosis
7.1 Point-of-Care Devices and their Importance in Renal Diseases Diagnosis
7.2 Various Biomarkers for Kidney Disease Diagnosis
7.3 Point-of-Care Devices for Kidney Injury Diagnosis
7.4 New Avenues in Developing POC for Renal Diseases
7.5 Conclusion
References
Chapter 8: From Natural to Artificial Biorecognition Elements: From Antibodies to Molecularly Imprinted Polymers
8.1 Introduction
8.2 Development and Production of Recognition Elements
8.2.1 Antibodies
8.2.2 APTAMERs
8.2.3 Molecularly Imprinted Polymers (MIPs)
8.3 Conclusions
References
Chapter 9: Design and Development of a Bed-Side Cardiac Health Monitoring Device
9.1 Introduction
9.1.1 Tissue as a Conductor
9.2 Evolution of Bio-Impedance: Impedance Cardiography
9.3 Significance of Non-Invasive Recording of Cardiac Parameters
9.4 Physiological and Clinical Applications of Impedance Cardiography
9.5 Designing an Electrode - Skin Model for Simulation Studies
9.5.1 Current Density
9.5.2 Resistive Loss
9.5.3 Electric Field Displacement
9.6 ICG Acquisition
9.6.1 Frequency and Current Values
9.6.2 ICG Measurement Methods
9.7 ICG Device Fabrication
9.8 Conclusion
References
Chapter 10: Tailoring Multi-Functional 1D or 2D Nanomaterials: An Approach towards Engineering Futuristic Ultrasensitive Platf...
10.1 Introduction
10.2 1D or 2D Nanomaterials and its Sensing Application
10.2.1 1D Nanomaterials
10.2.1.1 Nanofibers
10.2.1.2 Nanowires
10.2.1.3 Nanotubes
10.2.1.4 Nanorods
10.2.2 2D Nanomaterials
10.2.2.1 Graphene
10.2.2.2 Transition Metal Dichalcogenides
10.3 Functionalization Routes towards Microbial Detection
10.4 1D or 2D Nanomaterials in Nano/Micro-Gap Based Sensing Devices
10.4.1 Planar Gaps
10.4.2 Planar Gap Based FET Devices
10.4.3 Vertical Gap
10.5 Sample Preparation
10.5.1 Cultures
10.5.2 Tissues
10.5.3 Blood/Serum/Plasma
10.6 Extraction of Biological Molecules for Molecular Detection
10.6.1 Nucleic Acid Extraction
10.6.2 Protein Extraction
10.6.3 Automated Nucleic Acid Extraction Methods
10.7 Fluid Kinetics for Detection Systems
10.8 1D or 2D Material Based Optical Detection of Microbial Strains
10.8.1 Fluorescent Biosensor
10.8.2 FRET-Based Biosensors
10.8.3 Raman Based Sensor
10.8.4 DNA Based Sensor
10.9 Summary and Future Work
References
Chapter 11: Clinical Validation of the Medical Devices: A General Prospective
11.1 Introduction
11.2 What Is Clinical Evaluation?
11.2.1 Definition
11.2.2 Pre-Clinical Evaluation
11.3 Needs of Clinical Evaluation of Medical Devices
11.4 Type of Clinical Evaluation
11.4.1 Clinical Investigation
11.4.2 By Literature Way
11.5 Clinical Validation According to the Type of Devices
11.5.1 Clinical Validation
11.5.2 Process Validation
11.5.3 Revalidation
11.5.4 Design Validation
11.6 Clinical Validation for each Class of Medical Devices
11.7 Clinical and Analytical Validations of Biosensors Based IVDs
11.8 The Regulatory Perspective of the Medical Device in Consideration with Clinical Validation
11.8.1 Medical Device Rules (MDR)-2017, India
11.8.2 Food and Drug Administration USA
11.8.3 Medical Devices Clinical Validation Process in EU
11.8.4 Clinical Confirmatory Process in Australia
11.8.5 Medical Devices Clinical Validation in China
11.9 Conclusions
References
Chapter 12: Dried Blood Patterns for Diagnosis of Non-Communicable and Infectious Diseases
12.1 Introduction
12.2 Whole Blood and its Physical Properties
12.3 Physics of Pattern Formation
12.4 Factors Affecting the Pattern Formation
12.5 Disease Diagnosis Using the Dried Pattern of Blood Plasma and Serum
12.6 Disease Diagnosis Using the Dried Pattern of Whole Blood
12.7 Challenges and Future Outlook
References
Chapter 13: Theranostics: Principles, Materials, and Technical Advancements
13.1 Introduction to Principles of Theranostics
13.2 Materials for Cancer Theranostics
13.2.1 Gold-Based Nanosystems
13.2.2 Iron Oxide-Based Nanosystems
13.2.3 Other Metallic Nanosystems
13.2.4 Carbon-Based Nanosystems
13.2.5 Silica-Based Nanosystems
13.2.6 Quantum Dots-Based Nanosystems
13.2.7 Polymer-Based Nanosystems
13.2.8 Lipid-Based Nanosystems
13.3 Advanced Theranostic Nanomedicine Platforms for Clinical Applications
13.3.1 Photodynamic and Photothermal Therapy
13.3.2 Imaging
13.3.3 Nanobiosensors
13.3.4 Magnetic Hyperthermia
13.3.5 Multimodal Image Guided Therapy
13.3.6 Treatment of Cardiovascular Diseases
13.3.7 Treatment of Central Nervous System Related Diseases
13.4 Commercialization and Translational Challenges of Theranostic Nanosystems
13.5 Conclusion
References
Chapter 14: Nanotheranostics: Nanoparticles Applications, Perspectives, and Challenges
14.1 Introduction
14.2 Approaches Towards Nanotheranostics
14.2.1 Solid/Particles Approach
14.2.1.1 Quantum Dots
Synthesis and Modification of SQDs and CQDs for Bio-Applications
14.2.2 Liquid Approach
14.2.2.1 Liquid Metal Approach
14.2.3 Dry Approach
14.2.3.1 Electrospun Nanofibres
14.2.4 Biomacromolecule Based Approaches
14.2.4.1 Functionalized DNA with Nanoparticle
14.2.4.2 Antisense Oligonucleotides (ASOs)
14.2.4.3 Small RNA Mediated Therapeutics
14.3 Applications
14.3.1 Quantum Dots
14.3.1.1 Bioconjugate-QDs (B-QDs) for Cancer Diagnostic
14.3.1.2 In Vitro Imaging
14.3.1.3 In Vivo Imaging
14.3.1.4 B-QDs for Drug Delivery
14.3.1.5 Photodynamic Therapy (PDT)
14.3.2 Neurodegenerative Diseases (NDD)
14.3.2.1 Parkinson´s Disease (PD)
14.3.2.2 Theranostics Approaches for the Treatment of PD
14.3.3 Electrospun Nanofibers Application
14.3.3.1 Cancer Cell Capture
14.3.3.2 Regulate Cell Response
14.3.3.3 Cancer Cell Detection
14.3.3.4 Cancer Cell Imaging
14.3.3.5 Drug Delivery
14.3.4 Cardiovascular Diseases
14.3.5 Antimicrobial Drug Resistance
14.4 Challenge and Perspective
References