Dried Blood Spots E-Book

• Herausgeber: John Wiley & Sons
• Kategorie: Wissenschaft und neue Technologien
• Serie: Wiley Series on Pharmaceutical Science
• Sprache: Englisch

Seitenzahl: 1237

Veröffentlichungsjahr: 2014

Beschreibung

An informative and comprehensive book on the applications and techniques of dried blood spot sampling Dried blood spot (DBS) sampling involves the collection of a small volume of blood, via a simple prick or other means, from a study subject onto a cellulose or polymer paper card, which is followed by drying and transfer to the laboratory for analysis. For many years, this method of blood sample collection has been extensively utilized in some important areas of human healthcare (for example, newborn screening for inherited metabolic disorders and HIV-related epidemiological studies). Because of its advantages over conventional blood, plasma, or serum sample collection, DBS sampling has been valued by the pharmaceutical industry in drug research and development. Dried Blood Spots: Applications and Techniques features contributions from an international team of leading scientists in the field. Their contributions present a unique resource on the history, principles, procedures, methodologies, applications, and emerging technologies related to DBS. Presented in three parts, the book thoroughly examines: * Applications of DBS sampling and associated procedures and methodologies in various human healthcare studies * Applications and perspectives of DBS sampling in drug research and development, and therapeutic drug monitoring * New technologies and emerging applications related to DBS sampling and analysis Dried Blood Spots: Applications and Techniques is a valuable working guide for researchers, professionals, and students in healthcare, medical science, diagnostics, clinical chemistry, and pharmaceuticals, etc.

Leseprobe

WILEY SERIES ON PHARMACEUTICAL SCIENCE AND BIOTECHNOLOGY: PRACTICES, APPLICATIONS AND METHODS

Series Editors:

Mike S. LeeMilestone Development Services

Mike S. Lee • Integrated Strategies for Drug Discovery Using Mass Spectrometry

Birendra Pramanik, Mike S. Lee, and Guodong Chen • Characterization of Impurities and Degradants Using Mass Spectrometry

Mike S. Lee and Mingshe Zhu • Mass Spectrometry in Drug Metabolism and Disposition: Basic Principles and Applications

Mike S. Lee (editor) • Mass Spectrometry Handbook

Wenkui Li and Mike S. Lee • Dried Blood Spots—Applications and Techniques

DRIED BLOOD SPOTS

Applications and Techniques

Edited by

WENKUI LI

Novartis Institutes for BioMedical Research East Hanover, NJ, USA

MIKE S. LEE

Milestone Development Service Newtown, PA, USA

Copyright © 2014 by John Wiley & Sons, Inc. All rights reserved.

Published by John Wiley & Sons, Inc., Hoboken, New Jersey. Published simultaneously in Canada.

No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any form or by any means, electronic, mechanical, photocopying, recording, scanning, or otherwise, except as permitted under Section 107 or 108 of the 1976 United States Copyright Act, without either the prior written permission of the Publisher, or authorization through payment of the appropriate per-copy fee to the Copyright Clearance Center, Inc., 222 Rosewood Drive, Danvers, MA 01923, [phone], fax [phone], or on the web at www.copyright.com. Requests to the Publisher for permission should be addressed to the Permissions Department, John Wiley & Sons, Inc., 111 River Street, Hoboken, NJ 07030, [phone], fax [phone], or online at http://www.wiley.com/go/permissions.

Limit of Liability/Disclaimer of Warranty: While the publisher and author have used their best efforts in preparing this book, they make no representations or warranties with respect to the accuracy or completeness of the contents of this book and specifically disclaim any implied warranties of merchantability or fitness for a particular purpose. No warranty may be created or extended by sales representatives or written sales materials. The advice and strategies contained herein may not be suitable for your situation. You should consult with a professional where appropriate. Neither the publisher nor author shall be liable for any loss of profit or any other commercial damages, including but not limited to special, incidental, consequential, or other damages.

For general information on our other products and services or for technical support, please contact our Customer Care Department within the United States at [phone], outside the United States at [phone] or fax [phone].

Wiley also publishes its books in a variety of electronic formats. Some content that appears in print may not be available in electronic formats. For more information about Wiley products, visit our web site at www.wiley.com.

Library of Congress Cataloging-in-Publication Data

Dried blood spots : applications and techniques / edited by Wenkui Li, Novartis Institutes for BioMedical Research, East Hanover, NJ, USA, Mike S. Lee, Milestone Development Services.          pages cm    Includes index.    ISBN 978-1-118-05469-7 (cloth) 1. Blood–Collection and preservation.   2. Phlebotomy.   3. Forensic serology.   4. Forensic hematology.   I. Li, Wenkui, 1964- editor of compilation.   II. Lee, Mike S., 1960- editor of compilation.    RB45.15.D75 2014    616.07′561–dc23

2013047841

ISBN: 9781118054697

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

1.4 Conclusion

Notes

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

3.3 Sample storage and 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

5.3 Applications of ELISA Methods Using DBS

5.4 Optimization and ELISA methods validation using DBS specimens

5.5 Factors influencing the Performance of DBS-based ELISA Methods

5.6 Conclusions

Disclaimer

References

6 Applications of Dried Blood Spots in Newborn and Metabolic Screening

6.1 Introduction

6.2 Fundamentals of Dried Blood Spots

6.3 Analytical Methods in Newborn Screening

6.4 Detection of Metabolic Disease in a DBS

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

7.3 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

Notes

References

8 Use of Dried Blood Spot Samples in HCV-, HBV-, and Influenza-Related Epidemiological Studies

8.1 Hepatitis C Virus

8.2 Hepatitis B Virus

8.3 Influenza

References

9 Applications of Dried Blood Spots in General Human Health Studies

9.1 Introduction

9.2 Methodological Considerations in DBS Health Research

9.3 Case Studies

9.4 Summary and Conclusions

References

10 Applications of Dried Blood Spots in Environmental Population Studies

10.1 Application in Environmental Population Studies

10.2 Application of DBS For Biomonitoring of Environmental Chemicals

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

11.3 Forensic Toxicology and Dbs

11.4 Common Drugs of Abuse Detected in Dried Bloodstains

11.5 Conclusions

Notes

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

13.3 Extraction Techniques

13.4 Concluding Remarks

References

14 Considerations in Development and Validation of LC-MS/MS Method for Quantitative Analysis of Small Molecules in Dried Blood Spot Samples

14.1 Introduction

14.2 DBS-LC-MS/MS Method Development

14.3 DBS-LC-MS/MS Method Validation

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

16.3 Key Considerations for Using DBS for PK/TK 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

17.3 Progress and challenges in bioanalytical assay development

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

18.3 Results and Discussion of DBS Method Validation

18.4 Results and Discussion of Clinical Study

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

19.5 Dried Blood Spot Sampling in Therapeutic Drug Monitoring

19.6 Examples of Dried Blood Spot Sampling in Pediatric and Adult Clinical Pharmacology Trials

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

21.3 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

22.3 Direct Analysis in Context

22.4 Automated DBS Extraction

22.5 DBS Direct Elution

22.6 Direct Desorption

22.7 Conclusions: Direct Analysis Comparison, Current Trends, and Short-Term and Long-Term Prospects

Notes

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

24.3 Results and Discussion

24.4 Summary and Conclusions

Acknowledgment

References

25 Development of Biomarker Assays for Clinical Diagnostics Using a Digital Microfluidics Platform

25.1 Introduction

25.2 Materials and Methods

25.3 Results and Discussion

25.4 Summary and Conclusions

References

26 Applications and Chemistry of Cellulose Papers for Dried Blood Spots

26.1 Introduction

26.2 DBS Cards