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PATIENT CENTRIC BLOOD SAMPLING AND QUANTITATIVE ANALYSIS
Authoritative resource providing a complete overview of patient centric blood sampling, as well as its benefits and challenges
Patient Centric Blood Sampling and Quantitative Analysis focuses on the growing interest in alternative means to standard phlebotomy and analytical workflows for the collection and analysis of high-quality human biological samples for the quantitative determination of circulating drugs, their metabolites, and endogenous substances for clinical trials, routine healthcare and neonatal screening. The book clearly explains the benefits and constraints of having patients collect small volumes of blood in locations outside of a clinic (e.g at home), including: patient convenience; less invasive procedures; increased frequency of sampling; applicability to collecting samples from the young, elderly, and those in remote locations; greater frequency; and lower cost per sample. Readers will learn about approaches for successfully implementing patient centric sampling workflows in a number of scenarios, including the clinical setting and in the analytical laboratory.
Edited by four recognized experts in this field, with additional specialists in the discipline enlisted to write the component chapters, enabling greater depth and detail to be added and further raising the scientific standing of the publication, Patient Centric Blood Sampling and Quantitative Analysis includes information on:
* Basics of patient centric blood sampling and techniques and approaches that are available and in development for the collection and analysis of the samples
* Science behind patient centric blood sampling and its implications regarding human healthcare and wellbeing
* Application areas of patient centric sampling, including drug development, clinical chemistry/pathology, therapeutic drug monitoring, and more
* Practical approaches to successful implementation for existing and developing purposes and workflows, and case studies to support implementation within an organization
Giving the reader a broad understanding of what patient centric sampling is and where it might be applied for existing and potential future areas, Patient Centric Blood Sampling and Quantitative Analysis is an essential resource on the subject for many different types of laboratories, areas of clinical research and healthcare, including those in pharmaceutical, clinical, and research functions.
List of contents
List of Contributors xiii
Foreword xvii
Preface xix
1 Patient Centric Healthcare - What's Stopping Us? 1
Jenny Royle and Rachel Jones
1.1 The Evolution of Future Health Systems 1
1.2 Exploring the Barriers to Home Sampling 3
1.2.1 Barrier One--The Discord Between Innovation and Practice 4
1.2.2 Barrier Two--Ethical and Operational Considerations 5
1.2.3 Barrier Three--Where Does the Liability Sit? 7
1.2.4 Barrier Four--Addressing the Technology Challenge 8
1.2.5 Barrier Five--The Human Touch 9
1.2.6 Barrier Six--Trust in Data Security 10
1.2.7 Barrier 7--Adherence to Service Change 11
1.3 Conclusion: The Changing Role of Home Sampling 12
References 13
2 Tips for Successful Quantitative Assay Development Using Mitra Blood Sampling with Volumetric Absorptive Microsampling 17
James Rudge
2.1 What is Volumetric Absorptive Microsampling? 17
2.2 Tip 1--Ensure the Use of a Correct Sampling Procedure to Prevent Volume-Related Biases 18
2.3 Tip 2--Working with Wet Whole Blood 19
2.3.1 Is Your Choice of Assay Biologically Relevant in Blood? 19
2.3.2 Working with Blood as a Matrix 20
2.3.3 Allowing Analytes to Equilibrate Ex Vivo 21
2.3.4 Bridging Between Venous Capillary Blood and the Role of Anticoagulants 22
2.4 Tip 3--Working with Dried Whole Blood 24
2.4.1 Dried Blood Spot Cards 24
2.4.2 Volumetric Hematocrit Bias--Blood Viscosity 25
2.4.3 Dried Blood is a Complicated Matrix 26
2.4.4 Working with "Aged" Blood 26
2.4.5 Temporal Extraction Bias or Degradation? 27
2.5 Tip 4--Optimizing Extraction Efficiencies from VAMS 29
2.5.1 Measuring Percentage Recovery from Mitra Samplers 30
2.5.2 Extraction Conditions--Where to Start 31
2.5.2.1 Consulting the Literature and Matching Physicochemical Properties 31
2.5.2.2 Adapting Published DBS Methods 32
2.5.2.3 Converting from a Wet (Whole Blood or Plasma) Method 32
2.5.2.4 Starting from a Blank Canvas--What to Consider? 33
2.5.2.5 Choice of Matrix 35
2.5.3 Aqueous Extraction Conditions 36
2.5.4 Organic Extraction Conditions 37
2.5.5 Generic Extraction Conditions 39
2.6 Conclusions 40
References 41
3 Preanalytical Considerations for Implementation of Microsampling Solutions 49
Bradley B. Collier, Peyton K. Miesse, and Russell P. Grant
3.1 Introduction 49
3.2 Sample Matrices 50
3.2.1 Venous Sample 51
3.2.2 Capillary Blood 54
3.2.3 Material Selection 62
3.2.4 Dried Samples 62
3.2.5 Conclusions 63
3.3 Alternate Sample Acceptance Criteria 63
3.4 Collection 65
3.4.1 Device and Kit Components 66
3.4.2 Training and Preparation 67
3.4.3 Wound Generation 68
3.4.4 Collecting Sample 70
3.4.5 Post Collection Processing 72
3.4.6 Conclusions 72
3.5 Transportation and Sample Stability 73
3.5.1 Specimen Matrix and Separation 73
3.5.2 Storage Condition 74
3.5.3 Measurement Technique 77
3.5.4 Hematocrit Effects 79
3.5.5 Conclusions 79
3.6 Preanalytical Processing 80
3.6.1 Separation of Plasma and Serum 80
3.6.2 Sample Dilution 81
3.6.3 Conclusions 82
3.7 Overall Conclusions 82
References 83
4 Collection and Bioanalysis of Quantitative Microsamples: Technological Innovations and Practical Implications 93
Regina
About the author
Neil Spooner, Ph.D., C.Chem., F.R.S.C., is the Founder of Spooner Bioanalytical Solutions and the Patient Centric Sampling Interest Group (PCSIG) where he champions the implementation of patient centric sampling approaches. Dr Spooner is also the Editor In Chief of Bioanalysis Journal and is a Senior Visiting Research Fellow at the University of Hertfordshire, UK.
Emily Ehrenfeld is President of New Objective, Inc, an industry leader in high performance nano/microflow technologies.
Joe Siple is Director, Corporate Relations for New Objective, Inc., an industry leader in high performance nano/microflow technologies.
Mike S. Lee, PhD, is the founder of the Annual Symposium on Clinical and Pharmaceutical Solutions and Analysis (CPSA) and is the CEO of New Objective, Inc, an industry leader in high performance nano/microflow technologies.
