Analytical Techniques for Clinical Chemistry

SERGIO CAROLI, PhD, was a research director in the Department of Food and Animal Safety, National Institute of Health in Rome, and Honorary Professor at Eötvös Loránd University. He is the author of approximately 400 papers and editor or coauthor of six books, including The Determination of Chemical Elements in Food: Applications for Atomic and Mass Spectrometry (Wiley).GYULA ZÁRAY, PhD, DSc, is a Professor of Analytical Chemistry and the Director of the Cooperative Research Centre for Environmental Sciences at Eötvös Loránd University in Budapest. He has written more than 180 peer-reviewed publications and is the editor or coauthor of three books.

“This book is unique in its composition, as it focuses mainly on the analysis of heavy metals and trace elements but also includes some chapters that describe different aspects of the analysis of biological fluids and some other chapters on the analysis of pharmaceutical products. Based on the title of the book, it can be compared with other books that describe analytical techniques in clinical chemistry or clinical biochemistry.”  (Anal Bioanal Chem, 29 December 2013)“The book is certainly worth buying for a laboratory or institution library, and individual chapters might be a useful background reading for specific topics that are covered in an analytical or clinical university course.”  (Accreditation and Quality Assurance, 1 October 2013)

• FOREWORD xxiiiPREFACE xxvCONTRIBUTORS xxviiPART I Exploring Fundamentals 11. Good Clinical Practice Principles: Legal Background and Applicability 3Umberto Filibeck, Angela Del Vecchio, and Fabrizio Galliccia1.1. Introduction 41.2. Good Clinical Practice 41.3. Good Clinical Practice: Legal Background in the European Union 81.4. Good Clinical Practice: Applicability in the European Union 101.5. Good Clinical Practice and Bioequivalence Trials: GCP Inspections and Laboratories 131.6. Good Clinical Practice for Clinical Trials with Advanced Therapy Medicinal Product 201.7. Good Clinical Practice and Clinical Trials in Developing Countries 222. Clinical Chemistry and the Quest for Quality 29Sergio Caroli2.1. Introduction 302.2. Quality Today 312.3. Conclusions 553. Uncertainty in Clinical Chemistry Measurements Including Preanalytical Variables 59Marit Sverresdotter Sylte, Tore Wentzel-Larsen, and Bjørn J. Bolann3.1. Introduction 603.2. Analytical Uncertainty in Laboratory Results 623.3. Trueness and Traceability 673.4. Proficiency Testing 743.5. Biological Variations and Quality Goals 773.6. Reference Intervals 803.7. Estimating Preanalytical Uncertainty 833.8. Conclusions 924. The Role and Significance of Reference Values in the Identification and Evaluation of Trace Elements from Diet 97Pietro Apostoli and Maria Cristina Ricossa4.1. Reference Values 974.2. Reference Values in Specific Groups of Population: The Children Case 1004.3. Trace Elements and Diet 1064.4. Arsenic 1084.5. Mercury 1104.6. Lead 1124.7. Chromium 1144.8. Cadmium 1154.9. Conclusions 1165. Sample Collection, Storage, and Pretreatment in Clinical Chemistry 127Andrew Taylor5.1. Introduction 1285.2. Collection Procedures 1295.3. Storage 1325.4. Pretreatment 1335.5. Conclusions 1366. Metal Toxicology in Clinical, Forensic, and Chemical Pathology 139Jose A. Centeno, Todor I. Todorov, Gijsbert B. van der Voet, and Florabel G. Mullick6.1. Introduction 1406.2. Biological Markers 1406.3. Methodology for Trace Metal Ion Analysis in Clinical, Forensic, and Chemical Pathology 1416.4. Case Studies of Relevance to Research and Diagnosis on Clinical Chemistry, Forensic Toxicology, and Chemical Pathology 144PART II Selected Applications 1577. Elemental Speciation in Clinical Sciences 159Douglas M. Templeton7.1. Introduction 1597.2. Selected Elements 1677.3. Conclusions 1728. The Role of Analytical Chemistry in the Safety of Drug Therapy 179Sandor Gorog8.1. Drug Quality and Analysis: Their Role in Drug Safety 1808.2. Methodological Aspects 1898.3. The Role of Analytical Chemistry in Drug Research, Development, and Production 2008.4. Future Trends 2279. Analytical Techniques and Quality Control of Pharmaceuticals 245Fedele Manna, Francesca Rossi, and Rossella Fioravanti9.1. Introduction 2459.2. Sources of Impurities in Medicines 2469.3. Validation of Analytical Methods 2479.4. Analytical Approaches 2509.5. Conclusions 25310. Detection of Drugs in Biological Fluids for Antidoping Control 257Sabina Strano Rossi and Marcello Chiarotti10.1. Introduction 25710.2. Doping Control and Analytical Requirements 25810.3. Confirmation Techniques 26210.4. Conclusions 26411. The Applicability of Plasma-Based Techniques to Biological Monitoring 269Ilse Steffan and Goran Vujicic11.1. Introduction 26911.2. ICP as a Spectrochemical Source 27111.3. Element Analysis in Environmental and Biological Materials 27611.4. Conclusions 29212. Atomic Spectrometric Techniques for the Analysis of Clinical Samples 319Pilar Bermejo Barrera, Antonio Moreda Pineiro, and Marya del Carmen Barciela Alonso12.1. Introduction 32012.2. Analytical Techniques 32012.3. Sample Preparation 34712.4. Speciation Analysis 35112.5. Quality Control in Trace Element Determination 35512.6. Conclusions 35813. Applications of ICP-MS in Human Biomonitoring Studies 367Peter Heitland and Helmut D. Koster13.1. Introduction 36713.2. Advantages and Limitations of Inductively Coupled Plasma Mass Spectrometry 36813.3. Sample Collection and Storage 37013.4. Sample Preparation 37113.5. Human Biomonitoring by Inductively Coupled Plasma Mass Spectrometry 37413.6. Trace Element Speciation and Metallomics 38213.7. Determination of Stable Isotopes 38413.8. Method Validation and Quality Assurance 38413.9. Conclusions 38714. Molybdenum in Biological Samples and Clinical Significance of Serum Molybdenum 397Munehiro Yoshida14.1. Introduction 39714.2. Analysis of Molybdenum in Biological Samples by Inductively Coupled Plasma Mass Spectrometry 39814.3. Molybdenum in Food 40014.4. Molybdenum in Human Samples 40114.5. Clinical Significance of Serum and Plasma Mo 40414.6. Conclusions 40615. Application of Organometallic Speciation in Clinical Studies 409Bin He, Chungang Yuan, Jing Sun, and Guibin Jiang15.1. Introduction 40915.2. Arsenic 41015.3. Mercury 42215.4. Tin 43215.5. Conclusions 44116. Biosensors for Drug Analysis 455Daniela Deriu and Franco Mazzei16.1. Introduction 45516.2. Basic Concepts 45616.3. Electrochemical Biosensors 46016.4. Surface Plasmon Resonance 46216.5. Biosensors for Drugs Analysis 46516.6. Conclusions 47117. Bioimaging of Metals and Proteomic Studies of Clinical Samples by Laser Ablation Inductively Coupled Plasma Mass Spectrometry (LA-ICP-MS) 479J. Sabine Becker and J. Susanne Becker17.1. Introduction 48017.2. Analytical Approaches 48117.3. Experimental Aspects of Imaging Laser Ablation Inductively Coupled Plasma Mass Spectrometry 48517.4. Conclusions 49818. Applications of LC-MS/MS in Clinical Laboratory Diagnostics 507Uta Ceglarek, Georg Martin Fiedler, and Joachim Thiery18.1. Introduction 50718.2. Current Applications and Future Perspectives 51318.3. Liquid Chromatography-Tandem Mass Spectrometry Applications in Clinical Laboratories 52018.4. Conclusions 52819. Metabolomics Using UPLC/HPLC-Tandem Mass Spectrometry in Diagnosis and Research of Inherited Metabolic Diseases 535Willem Kulik and Andre B. P. van Kuilenburg19.1. Introduction 53619.2. Acylcarnitines 53719.3. Acyl-Coenzyme A Thioesters 53819.4. Amino Acids 54019.5. Organic Acids 54219.6. Purines and Pyrimidines 54219.7. Bile Acids 54419.8. Lipidomics 54519.9. Carbohydrates 54819.10. Neurotransmitters 54819.11. Conclusions 54920. Biomarkers of Oxidative Stress in Plasma and Urine 555Papasani V. Subbaiah20.1. Introduction 55620.2. Antioxidant Mechanisms and Assays 55820.3. Concluding Remarks and Perspectives 58321. The Use of X-Ray Techniques in Medical Research 595Imre Szaloki, Gyula Zaray, and Norbert Szoboszlai21.1. Introduction 59521.2. Physical Basis of XRF Analytical Methods 59621.3. Basic Equipment and Setup for X-Ray Fluorescence Analysis 59721.4. Quantification Approaches 60621.5. Sample Preparation Techniques 60921.6. Applications 61021.7. Conclusions 617PART III Future Trends 62522. A New Tool Based on the Use of Stable Isotopes and Isotope Pattern Deconvolution (IPD)-ICP-MS for Nutritional and Clinical Studies 627Hector Gonzalez Iglesias, Maria Luisa Fernandez-Sanchez, and Alfredo Sanz-Medel22.1. Introduction 62722.2. Milk as Source of Trace Elements 62822.3. Stable Isotopes and Trace Elements Metabolism 62922.4. Isotope Pattern Deconvolution 63122.5. Selenium Metabolism in Lactating Rats by Means of Stable Isotopes and Isotope Pattern Deconvolution 63122.6. Determination of Selenium in Urine, Faeces, Serum, and Erythrocytes by Isotope Pattern Deconvolution Inductively Coupled Plasma Mass Spectrometry 63422.7. Quantitative Speciation of Selenium in Urine, Serum, and Erythrocytes by High Performance Isotope Pattern Deconvolution Inductively Coupled Plasma Mass Spectrometry 63722.8. An Application of Isotope Pattern Deconvolution to Clinical Studies 64322.9. Conclusions 64523. Breath Analysis: Analytical Methodologies and Clinical Applications 651Alessio Ceccarini, Fabio Di Francesco, Roger Fuoco, Silvia Ghimenti, Massimo Onor, Sara Tabucchi, and Maria Giovanna Trivella23.1. Introduction 65223.2. Sampling Methods 65523.3. Analytical Techniques 65823.4. Application of Breath Analysis 66423.5. Exposure Assessment 67523.6. Exhaled Breath Condensate 67723.7. Conclusions 67724. Proteo-Metabolomic Strategies in the Future of Drug Development 691Uwe Christians, Volker Schmitz, Jost Klawitter, and Jelena Klawitter24.1. Introduction 69224.2. The Principles of Molecular Marker Development 69924.3. Technologies for Molecular Marker Development 71824.4. Molecular Markers in Drug Development and Clinical Monitoring 73724.5. Current Challenges 74925. Basics in Laboratory Medicine: Past, Present, and Future 775Lorand A. Debreczeni, Anna Kovacsay, and Sandor Nagy25.1. Introduction 77625.2. Informatics 77725.3. Global Standardization 77825.4. Focus on the Individual 78225.5. A Look into the Future 783References 784INDEX 787