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 studiesApplications and perspectives of DBS sampling in drug research and development, and therapeutic drug monitoringNew 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.

WENKUI LI currently serves as Senior Fellow in the Department of Drug Metabolism& Pharmacokinetics at Novartis Institutes for BioMedical Research, where he focuses on regulated LC-MS/MS bioanalysis for the toxicokinetic and pharmacokinetic assessment of drug candidates. Dr. Li is a member of the editorial board ofBiomedical Chromatography.

MIKE S. LEE currently serves as a provider of consulting services specializing in pharmaceutical analysis, accelerated drug discovery and development strategies, and analytical technologies. He has delivered many presentations as invited speaker, plenary speaker, and workshops instructor in the areas of drug discovery and development at universities, conferences, and industrial technical centers. He has published numerous papers and books and obtained two U.S. patents.

PREFACE viii

CONTRIBUTORS x

PART I HISTORY, APPLICATIONS, AND HEALTHCARE

1 Overview of the History and Applications of Dried Blood Samples 3W. Harry Hannon and Bradford L. Therrell, Jr.

2 Dried Blood Spot Cards 16Brad Davin and W. Harry Hannon

3 Dried Blood Spot Sample Collection, Storage, and Transportation 21Joanne Mei

4 Dried Blood Spot Specimens for Polymerase Chain Reaction in Molecular Diagnostics and Public Health Surveillance 32Chunfu Yang

5 Application of Enzyme Immunoassay Methods Using Dried Blood Spot Specimens 40Mireille B. Kalou

6 Applications of Dried Blood Spots in Newborn and Metabolic Screening 53Donald H. Chace, Alan R. Spitzer, and Víctor R. De Jesús

7 Dried Blood Spots for Use in HIV-Related Epidemiological Studies in Resource-Limited Settings 76Sridhar V. Basavaraju and John P. Pitman

8 Use of Dried Blood Spot Samples in HCV-, HBV-, and Influenza-Related Epidemiological Studies 95Harleen Gakhar and Mark Holodniy

9 Applications of Dried Blood Spots in General Human Health Studies 114Eleanor Brindle, Kathleen A. OConnor, and Dean A. Garrett

10 Applications of Dried Blood Spots in Environmental Population Studies 130Antonia M. Calafat and Kayoko Kato

11 The Use of Dried Blood Spots and Stains in Forensic Science 140Donald H. Chace and Nicholas T. Lappas

PART II PHARMACEUTICAL APPLICATIONS

12 Pharmaceutical Perspectives of Use of Dried Blood Spots 153Christopher Evans and Neil Spooner

13 Punching and Extraction Techniques for Dried Blood Spot Sample Analysis 160Philip Wong and Christopher A. James

14 Considerations in Development and Validation of LC-MS/MS Method for Quantitative Analysis of Small Molecules in Dried Blood Spot Samples 168Wenkui Li

15 Challenges and Experiences with Dried Blood Spot Technology for Method Development and Validation 179Chester L. Bowen and Christopher A. Evans

16 Clinical Implications of Dried Blood Spot Assays for Biotherapeutics 188Matthew E. Szapacs and Jonathan R. Kehler

17 Potential Role for Dried Blood Spot Sampling and Bioanalysis in Preclinical Studies 195Qin C. Ji and Laura Patrone

18 Clinical and Bioanalytical Evaluation of Dried Blood Spot Sampling for Genotyping and Phenotyping of Cytochrome p450 Enzymes in Healthy Volunteers 202Theo de Boer, Izaak den Daas, Jaap Wieling, Johan Wemer, and LingSing Chen

19 Application of Dried Blood Spot Sampling in Clinical Pharmacology Trials and Therapeutic Drug Monitoring 216Kenneth Kulmatycki, Wenkui Li, Xiaoying (Lucy) Xu, and Venkateswar Jarugula

20 Automation in Dried Blood Spot Sample Collection, Processing, and Analysis for Quantitative Bioanalysis in Pharmaceutical Industry 229Leimin Fan, Katty Wan, Olga Kavetskaia, and Huaiqin Wu

21 Beyond Dried Blood SpotsApplication of Dried Matrix Spots 235Shane R. Needham

PART III NEW TECHNOLOGIES AND EMERGING APPLICATIONS

22 Direct Analysis of Dried Blood Spot Samples 245Paul Abu-Rabie

23 Paper Spray Ionization for Direct Analysis of Dried Blood Spots 298Jiangjiang Liu, Nicholas E. Manicke, R. Graham Cooks, and Zheng Ouyang

24 Direct Solvent Extraction and Analysis of Biomarkers in Dried Blood Spots Using a Flow-Through Autosampler 314David S. Millington, Haoyue Zhang, M. Arthur Moseley, J. Will Thompson, and Peter Smith

25 Development of Biomarker Assays for Clinical Diagnostics Using a Digital Microfluidics Platform 325David S. Millington, Ramakrishna Sista, Deeksha Bali, Allen E. Eckhardt, and Vamsee Pamula

26 Applications and Chemistry of Cellulose Papers for Dried Blood Spots 332Jacquelynn Luckwell, Åke Danielsson, Barry Johnson, Sarah Clegg, Mark Green, and Alan Pierce

27 Derivatization Techniques in Dried Blood Spot Analysis 344Ann-Sofie M.E. Ingels, Nele Sadones, Pieter M.M. De Kesel, Willy E. Lambert, and Christophe P. Stove

INDEX 355