Dried Blood Spots

Name: Dried Blood Spots | Applications and Techniques
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Applications and Techniques

Wenkui Li Mike S. Lee(Herausgeber*in)

Wiley (Verlag)

Erschienen am 12. Mai 2014

376 Seiten

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978-1-118-89090-5 (ISBN)

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Inhalt

Intro
Dried Blood Spots
Contents
Preface
Contributors
PART I History, Applications, and Healthcare
1 Overview of the History and Applications of Dried Blood Samples
1.1 History
1.2 Historical Applications
1.3 Overall Advantages and Disadvantages of Dried-Blood Spot Sampling
1.3.1 Advantages
1.3.2 Disadvantages
1.4 Conclusion
References
2 Dried Blood Spot Cards
2.1 Introduction
2.2 Filter Paper
2.3 Filter Paper Sources
2.4 Guidelines and Printing
2.5 Printing Adaptations
2.6 Further Innovations in Manufacturing
2.7 Filter Paper Cards Construction
2.8 Wraparound Cover and Cassette Construction
2.9 Filter Paper Pre-Treatment
2.10 The Future of the Filter Paper Card
References
3 Dried Blood Spot Sample Collection, Storage, and Transportation
3.1 Introduction
3.2 General Procedures and Precautions for DBS Sample Collection
3.2.1 Reagents and Materials
3.2.2 Biosafety and Infection Control
3.2.3 Specimen Collection
3.2.4 DBS Prepared by Other Collection Methods
3.2.5 Labeling of DBS
3.2.6 Drying
3.3 Sample Storage and Transportation
3.3.1 Packaging and Storage
3.3.2 Transportation
3.4 Common Errors in Sample Collection, Storage, and Shipment
3.5 Conclusions
Disclaimer
References
4 Dried Blood Spot Specimens for Polymerase Chain Reaction in Molecular Diagnostics and Public Health Surveillance
4.1 Introduction
4.2 Pioneering DBS Nucleic Acid Extraction Methods for PCR
4.3 Direct PCR Amplification of Targeted Genomic DNA from DBS
4.4 Expansion of DBS-PCR from Newborn Screening to Diagnosis of Infectious and other Diseases
4.5 Application of DBS-PCR in Sequencing-Based Molecular Epidemiology Analyses
4.6 Application of DBS-PCR for HIV Drug Resistance Surveillance and Monitoring in Resource-Limited Settings
4.7 Quantitation of Infectious Agent Particles with DBS-PCR
4.8 Conclusions
References
5 Application of Enzyme Immunoassay Methods Using Dried Blood Spot Specimens
5.1 Introduction
5.2 Overview of Basic ELISA Systems
5.2.1 Antibody Detection
5.2.2 Variation of ELISA Method for Antibody Detection
5.2.3 Variations of ELISA for Antigen Detection
5.3 Applications of ELISA Methods Using DBS
5.4 Optimization and ELISA Methods Validation Using DBS Specimens
5.4.1 DBS Elution Protocol
5.4.2 Defining Cutoff Values
5.5 Factors Influencing the Performance of DBS-based ELISA Methods
5.5.1 DBS Preparation
5.5.2 Anticoagulant
5.5.3 Punching
5.5.4 Cross-Contamination
5.6 Conclusions
Disclaimer
References
6 Applications of Dried Blood Spots in Newborn and Metabolic Screening
6.1 Introduction
6.1.1 History and Chronology in the Use of DBS in NBS
6.1.2 Chapter Organization and Perspectives
6.2 Fundamentals of Dried Blood Spots
6.2.1 A Class II Medical Device
6.2.2 Liquid versus Dried Blood Specimens
6.2.3 Interaction of Paper with Biological Matrix and Substrates
6.2.4 Sample Collection and DBS
6.3 Analytical Methods in Newborn Screening
6.3.1 Fundamental Premise
6.3.2 Classical Methods Overview
6.3.3 Fluorometry
6.3.4 Immunoassays
6.3.5 Electrophoresis
6.3.6 Tandem Mass Spectrometry (MSMS)
6.3.7 Molecular Methods
6.4 Detection of Metabolic Disease in a DBS
6.4.1 Overview
6.4.2 Results and Interpretation of Newborn Screening of DBS Perspective
6.4.3 Chemical Interferences in DBS Analysis in NBS
6.4.4 From Lab Test to Diagnosis (Bench to Bedside)
6.4.5 Improving DBS Screening Accuracy Using Second-Tier Tests
6.5 Newborn Screening as a Subset of Metabolic Screening
6.6 Prognostications and Predictions
Disclaimer
References
7 Dried Blood Spots for Use in HIV-Related Epidemiological Studies in Resource-Limited Settings
7.1 Background
7.2 Initial Studies Describing HIV Detection in Dried Blood Spots
7.2.1 Surveillance
7.2.2 Viral Load Monitoring
7.2.3 Drug Resistance Testing
7.3 Prevention of Mother-to-Child HIV Transmission (PMTCT) and Early Diagnosis of HIV Infection Among Infants
7.4 Emerging Strategies and Applications of DBS in HIV-Related Epidemiological Studies in Resource-Limited Settings
7.5 Conclusion
Disclaimer
References
8 Use of Dried Blood Spot Samples in HCV-, HBV-, and Influenza-Related Epidemiological Studies
8.1 Hepatitis C Virus
8.1.1 Introduction
8.1.2 Epidemiology
8.1.3 Diagnosis
8.1.4 Use of Dried Blood for HCV Diagnosis and Treatment
8.1.5 DBS Utility
8.1.6 Summary
8.2 Hepatitis B Virus
8.2.1 Epidemiology
8.2.2 Transmission
8.2.3 Diagnosis
8.2.4 Dried Blood Spots for HBV Diagnosis and Management
8.2.5 Summary
8.3 Influenza
8.3.1 Introduction
8.3.2 Clinical Features
8.3.3 Diagnosis
8.3.4 Dry Respiratory Sample
8.3.5 Summary
References
9 Applications of Dried Blood Spots in General Human Health Studies
9.1 Introduction
9.1.1 Clinical and Non-Clinical Health Research
9.1.2 DBS Use in Public and Population Health Settings
9.2 Methodological Considerations in DBS Health Research
9.2.1 DBS Collection Strategies
9.2.2 Specimen Treatment, Biohazard, and Safety Issues
9.2.3 Storing DBS for Future Use
9.2.4 Comparability of DBS and Venous Blood Assay Results
9.2.5 DBS Biomarker Assays
9.2.6 Limitations of DBS
9.3 Case Studies
9.3.1 DBS in Demographic and Health Surveys
9.3.2 DBS in the Health Initiatives for Men Study
9.4 Summary and Conclusions
References
10 Applications of Dried Blood Spots in Environmental Population Studies
10.1 Application in Environmental Population Studies
10.1.1 Introduction
10.1.2 Analytical Considerations for Biomonitoring Using DBS
10.1.3 Selection of Biomarkers of Environmental Chemicals
10.1.4 Storage of Residual DBS and Their Potential Impact for DBS Use in Biomonitoring
10.1.5 Advantages of Using DBS for Biomonitoring
10.1.6 Disadvantages of Using DBS
10.2 Application of DBS for Biomonitoring of Environmental Chemicals
10.2.1 Metals
10.2.2 Dichlorodiphenyldichloroethylene
10.2.3 Hexachlorohexane and DDT
10.2.4 PFCs
10.2.5 Perchlorate
10.2.6 Measurement of Protein Adducts
10.2.7 Novel Analytical Technologies with Potential Applications in DBS Biomonitoring
10.2.8 Biomonitoring of Nonhuman Species
10.3 Conclusions
Disclaimer
References
11 The Use of Dried Blood Spots and Stains in Forensic Science
11.1 Introduction
11.2 Forensic Metabolic Pathology
11.2.1 The Metabolic Autopsy
11.3 Forensic Toxicology and DBS
11.4 Common Drugs of Abuse Detected in Dried Bloodstains
11.4.1 Cocaine and Its Metabolites
11.4.2 Benzodiazepines
11.4.3 Amphetamines
11.4.4 Opioids
11.4.5 Cannabinoids
11.5 Conclusions
References
PART II Pharmaceutical Applications
12 Pharmaceutical Perspectives of Use of Dried Blood Spots
12.1 Early Developments
12.2 In-Depth Investigations
12.3 Validation Requirements
12.4 Publication Explosion!
12.5 Other Uses of DBS Sampling for Pharmaceutical Development
12.6 Hurdles
12.7 The Way Ahead!
12.8 Conclusions
References
13 Punching and Extraction Techniques for Dried Blood Spot Sample Analysis
13.1 Introduction
13.2 Punching
13.2.1 Punching Devices
13.2.2 Volumetric Issue
13.2.3 Effect of Punch Positions
13.3 Extraction Techniques
13.3.1 Solvent Extraction
13.3.2 Protein Precipitation
13.3.3 Liquid-Liquid Extraction
13.3.4 Solid-phase Extraction
13.4 Concluding Remarks
References
14 Considerations in Development and Validation of LC-MSMS Method for Quantitative Analysis of Small Molecules in Dried Blood Spot Samples
14.1 Introduction
14.2 DBS-LC-MSMS Method Development
14.2.1 DBS Card Selection and Assay Sensitivity Assessment
14.2.2 Impact Assessment of DBS Sample Properties on Assay Performance
14.2.3 Sample Extraction
14.2.4 Stability and Instability versus Nonspecific Interaction of Analyte with Card Materials
14.3 DBS-LC-MSMS Method Validation
14.3.1 Sensitivity and Selectivity
14.3.2 Matrix Effect and Recovery
14.3.3 Precision and Accuracy
14.3.4 Dilution Integrity
14.3.5 Carryover
14.3.6 Incurred Sample Reanalysis
14.3.7 Stability
14.3.8 Blood Volume Impact
14.3.9 Spreadability Impact
14.4 Conclusions
References
15 Challenges and Experiences with Dried Blood Spot Technology for Method Development and Validation
15.1 Introduction
15.2 Sample Collection
15.3 Sample Preparation and Processing
15.4 Sample Transportation and Storage Variables
15.5 Bioanalysis Options and Capability of Direct Analysis
15.6 Conclusions
References
16 Clinical Implications of Dried Blood Spot Assays for Biotherapeutics
16.1 Introduction
16.2 Review of Recent Literature
16.2.1 Card Types
16.2.2 Quantitation of Biopharmaceutical Compounds from DBS Cards (PK, TK, Biomarkers)
16.2.3 Stability of Peptides/Proteins on DBS Cards
16.2.4 Hematocrit
16.3 Key Considerations for Using DBS for PKTK Support of Biotherapeutics
References
17 Potential Role for Dried Blood Spot Sampling and Bioanalysis in Preclinical Studies
17.1 Introduction
17.2 Importance of Exposure Measurements
17.2.1 Limited Blood Volume
17.2.2 Blood Collection Methods
17.3 Progress and Challenges in Bioanalytical Assay Development
17.3.1 DBS Sample Preparation and Analyte Elution Efficiency
17.3.2 DBS Sample Dilutions
17.3.3 Impact of Hematocrit on Blood-to-Plasma Concentration Ratio
17.3.4 Impact of Hematocrit on Bioanalytical Measurement and Potential Solutions
17.3.5 Potential Differences between DBS Samples and Ex Vivo Calibration Standards/Quality Control Samples
17.3.6 Sample Storage Stability
17.4 Conclusions
Acknowledgments
Disclaimer
References
18 Clinical and Bioanalytical Evaluation of Dried Blood Spot Sampling for Genotyping and Phenotyping of Cytochrome P450 Enzymes in Healthy Volunteers
18.1 Introduction
18.2 Experimental
18.2.1 Chemicals, Solvents, and Blank Matrices
18.2.2 Chromatographic System
18.2.3 Preparation of Stock Solutions, Calibration Standards, and Quality Control Samples
18.2.4 Blood Sampling Procedures
18.2.5 Sample Pretreatment and Sample Preparation
18.2.6 Genomic DNA Isolation
18.2.7 Genotyping Assays
18.2.8 Validation Procedures for the Quantitative Analysis of MDZ and 1-OH MDZ in Human DBS Samples by LC-MSMS
18.2.9 Clinical Study Design
18.3 Results and Discussion of DBS Method Validation
18.3.1 Selectivity with Respect to Endogenous and Exogenous Substances
18.3.2 Assessment of Mutual Interference of MDZ, 1-OH MDZ, and ISs
18.3.3 Linearity
18.3.4 Accuracy and Precision
18.3.5 Dilution Integrity
18.3.6 Recovery
18.3.7 Matrix Effect (Ion Suppression or Enhancement)
18.3.8 Carryover
18.3.9 Stability Experiments
18.3.10 Disc Size and Disc Number Integrity
18.4 Results and Discussion of Clinical Study
18.4.1 Clinical Conduct
18.4.2 Bioanalysis
18.4.3 DBS Finger versus Venipuncture
18.4.4 Disc Numbers, Disc Size, Storage Stability
18.4.5 Limited versus Extensive Sampling
18.4.6 Analysis of 1-OH MDZ
18.4.7 Genotyping
18.4.8 Subject and Phlebotomist Satisfaction
18.5 Summary
Acknowledgments
References
19 Application of Dried Blood Spot Sampling in Clinical Pharmacology Trials and Therapeutic Drug Monitoring
19.1 Introduction
19.2 Advantages and Disadvantages of Dried Blood Spot Sampling in Clinical Pharmacology Trials and Therapeutic Drug Monitoring
19.3 Dried Blood Spot Collection in Clinical Pharmacology Trials and Therapeutic Drug Monitoring
19.4 Pharmacokinetic-Pharmacodynamic Considerations of Dried Blood Spot Sampling in Clinical Pharmacology Trials and Therapeutic Drug Monitoring
19.4.1 Blood Plasma Distribution
19.4.2 Impact of Hematocrit
19.4.3 Bridging between Dried Blood Spots and Plasma Samples
19.4.4 Dried Plasma Spots as an Alternative to Dried Blood Spots
19.5 Dried Blood Spot Sampling in Therapeutic Drug Monitoring
19.5.1 Drug Monitoring and Dried Blood Spots
19.5.2 Pediatric Drug Monitoring and Dried Blood Spots
19.5.3 Transplantation Drug Monitoring and Dried Blood Spots
19.5.4 DBS Biomarker Measurement in Drug Monitoring
19.6 Examples of Dried Blood Spot Sampling in Pediatric and Adult Clinical Pharmacology Trials
19.6.1 DBS Sampling for Pediatric Studies
19.6.2 DBS Sampling for Clinical Pharmacology Studies with Adults
19.7 Conclusions
References
20 Automation in Dried Blood Spot Sample Collection, Processing, and Analysis for Quantitative Bioanalysis in Pharmaceutical Industry
20.1 Introduction
20.2 Automated Method Development
20.3 Automated Blood Collection and Spotting
20.4 Automation in Analysis of DBS Samples
20.5 General Issues Associated with DBS Automation
20.6 Future Outlook
References
21 Beyond Dried Blood Spots-Application of Dried Matrix Spots
21.1 Introduction
21.2 Dried Matrix Spot Analysis
21.2.1 Color-indicating Techniques
21.2.2 Addition of Internal Standard in Dried Matrix Spot Analysis
21.2.3 Automation of Dried Matrix Spot Analysis
21.3 Conclusions
References
Website References
PART III New Technologies and Emerging Applications
22 Direct Analysis of Dried Blood Spot Samples
22.1 Introduction
22.2 DBS in Context
22.2.1 Sampling of Wet Plasma versus Dried Blood Spots in Pharmaceutical Drug Development
22.2.2 Conventional Manual Extraction of Wet Plasma versus Dried Blood Spot Samples in Pharmaceutical Drug Development
22.3 Direct Analysis in Context
22.3.1 DBS Direct Analysis-Why Is It Desirable?
22.3.2 DBS Direct Analysis-What Are the Options Available?
22.3.3 Not Just Getting Ions into Gas Phase..Additional Functionality and Other Considerations
22.4 Automated DBS Extraction
22.5 DBS Direct Elution
22.5.1 Online DBS Analysis
22.5.2 Liquid Microjunction Surface-Sampling Probe and Liquid Extraction Surface Analysis
22.5.3 Sealing Surface Sampling Probe
22.5.4 Digital Microfluidics
22.6 Direct Desorption
22.6.1 Liquid and Gas Jet Desorption/Ionization
22.6.2 Thermal Desorption/Ionization
22.6.3 Laser Desorption (Ablation)/Ionization Techniques
22.6.4 Multimode Techniques
22.7 Conclusions: Direct Analysis Comparison, Current Trends, and Short-Term and Long-Term Prospects
22.7.1 Automated DBS Extraction
22.7.2 Direct Elution
22.7.3 Direct Desorption
References
23 Paper Spray Ionization for Direct Analysis of Dried Blood Spots
23.1 Introduction
23.2 Paper Spray in Practice
23.3 Fundamentals of Paper Spray
23.4 Chemical Interactions During Paper Spray
23.5 Quantitation of Drugs and Metabolites
23.6 Toward Point-of-Care Analysis
23.7 Outlook
Acknowledgment
References
24 Direct Solvent Extraction and Analysis of Biomarkers in Dried Blood Spots Using a Flow-Through Autosampler
24.1 Introduction
24.2 Materials and Methods
24.2.1 DBS Autosampler and MSMS Instrument Configuration
24.2.2 Direct Analysis of Acylcarnitines and Amino Acids from Dried Blood Spots
24.2.3 Analysis of Citrulline in DBS
24.2.4 Analysis of Methylmalonic Acid in Plasma Spots
24.3 Results and Discussion
24.3.1 Acylcarnitines and Amino Acids
24.3.2 Citrulline
24.3.3 Methylmalonic Acid
24.4 Summary and Conclusions
Acknowledgment
References
25 Development of Biomarker Assays for Clinical Diagnostics Using a Digital Microfluidics Platform
25.1 Introduction
25.1.1 Digital Microfluidic Technology
25.1.2 Digital Microfluidic Assays on DBS and Whole Blood
25.2 Materials and Methods
25.2.1 Digital Microfluidic Equipment
25.2.2 Enzymatic Assays for Lysosomal Storage Disease
25.3 Results and Discussion
25.3.1 Enzymatic Assays for Lysosomal Storage Disorders
25.4 Summary and Conclusions
References
26 Applications and Chemistry of Cellulose Papers for Dried Blood Spots
26.1 Introduction
26.2 DBS Cards
26.3 Quality Management
26.4 Paper Manufacturing
26.5 FTAT DMPK Card Selection
26.6 Applications Using Dried Blood Spot Analysis
26.6.1 WhatmanT Indicating FTAT DMPK Cards
26.6.2 Recovery Testing Using Indicating versus Non-indicating FTA DMPK Cards
26.6.3 Variation between Indicating and Corresponding Non-indicating Card
26.6.4 FTA Cards for the Storage of DNA in Blood
26.6.5 FTA Cards for the Storage of RNA
26.6.6 Detection of Protein Analytes Using FTA Cards
26.7 Hints and Tips in Using Dried Blood Spots
References
27 Derivatization Techniques in Dried Blood Spot Analysis
27.1 Introduction
27.2 Overview of Derivatization Techniques in DBS Analysis
27.3 General DBS Sample Workup Procedure Including Derivatization
27.4 Modifications
27.4.1 Modified Sample Workup Procedure 1: Extraction-Evaporation-Derivatization
27.4.2 Modified Sample Workup Procedure 2: Two-Step Extraction-Derivatization
27.4.3 Modified Sample Workup Procedure 3: Direct Derivatization Techniques
27.5 Conclusion and Future Perspectives
References
Index

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