Mass Spectrometry for the Clinical Laboratory

1st Edition - November 2, 2016
Editors: Hari Nair, William Clarke
Language: English
Hardback ISBN:
9 7 8 - 0 - 1 2 - 8 0 0 8 7 1 - 3
eBook ISBN:
9 7 8 - 0 - 1 2 - 8 0 0 9 9 2 - 5

Mass Spectrometry for the Clinical Laboratory is an accessible guide to mass spectrometry and the development, validation, and implementation of the most common assays seen in c… Read more

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Mass Spectrometry for the Clinical Laboratory is an accessible guide to mass spectrometry and the development, validation, and implementation of the most common assays seen in clinical labs. It provides readers with practical examples for assay development, and experimental design for validation to meet CLIA requirements, appropriate interference testing, measuring, validation of ion suppression/matrix effects, and quality control. These tools offer guidance on what type of instrumentation is optimal for each assay, what options are available, and the pros and cons of each. Readers will find a full set of tools that are either directly related to the assay they want to adopt or for an analogous assay they could use as an example.

Written by expert users of the most common assays found in a clinical laboratory (clinical chemists, toxicologists, and clinical pathologists practicing mass spectrometry), the book lays out how experts in the field have chosen their mass spectrometers, purchased, installed, validated, and brought them on line for routine testing.

The early chapters of the book covers what the practitioners have learned from years of experience, the challenges they have faced, and their recommendations on how to build and validate assays to avoid problems. These chapters also include recommendations for maintaining continuity of quality in testing. The later parts of the book focuses on specific types of assays (therapeutic drugs, Vitamin D, hormones, etc.). Each chapter in this section has been written by an expert practitioner of an assay that is currently running in his or her clinical lab.

List of Contributors
Preface
Chapter 1: Mass spectrometry in the clinical laboratory: determining the need and avoiding pitfalls
- Abstract
- 1. Clinical mass spectrometry
Chapter 2: Application specific implementation of mass spectrometry platform in clinical laboratories
- Abstract
- 1. Mass spectrometry versus automated immunoassay platforms
- 2. Early decisions in the implementation of mass spectrometry in the laboratory
- 3. Importance of internal standards in mass spectrometry
- 4. Matrix effects, extraction efficiency, and ion suppression/enhancement
- 5. Analyte extraction
- 6. Choice of separation technique: GC versus LC
- 7. Choice of stationary phase
- 8. Choice of ionization techniques
- 9. Choice of mass analyzer
- 10. Summary
Chapter 3: Sample preparation techniques for mass spectrometry in the clinical laboratory
- Abstract
- 1. Why is sample preparation needed for LC-MS/MS?
- 2. Selecting a sample preparation protocol
- 3. Description of commonly used clinical sample preparation protocols
- 4. Evaluation of sample preparation protocols
- 5. Comparison of sample preparation protocols
- 6. Optimization of sample preparation protocols
- 7. Summary
Chapter 4: Validation, quality control, and compliance practice for mass spectrometry assays in the clinical laboratory
- Abstract
- 1. Introduction
- 2. Elements of assay validation according to CLIA, CAP, and FDA guidelines
- 3. Elements of quality control
- 4. Regulatory compliance
- 5. Additional resources from the literature
- 6. Summary
Chapter 5: Best practices for routine operation of clinical mass spectrometry assays
- Abstract
- 1. New assay implementation
- 2. System suitability standards
- 3. Verification of new materials
- 4. Sample analysis
- 5. Data review
- 6. Instrument maintenance
- 7. Quality assurance for specimen analysis
- 8. Conclusions
Chapter 6: Toxicology: liquid chromatography mass spectrometry
- Abstract
- 1. Toxicology testing in the clinical laboratory
- 2. Chromatographic methods for toxicology testing in the clinical laboratory
- 3. Toxicology LC-MS applications
- 4. Conclusions
Chapter 7: Toxicology: GCMS
- Abstract
- 1. Use and strengths of GC-MS in clinical toxicology
- 2. Limitations of GC-MS in clinical toxicology
- 3. Instrument selection
- 4. Defining an assay method
- 5. Analysis
- 6. Assay validation
- 7. Instrument maintenance and troubleshooting
- 8. Personnel/training
Chapter 8: Therapeutic drug monitoring using mass spectrometry
- Abstract
- 1. Background/introduction
- 2. MS considerations for TDM
- 3. Assay design/test life cycle considerations
- 4. Sample preparation considerations
- 5. Validation considerations
- 6. Quality control/quality assurance considerations
- 7. Conclusions
Chapter 9: Vitamin D metabolite quantitation by LC-MS/MS
- Abstract
- 1. Physiological role of vitamin D
- 2. Evolution of assays for vitamin D metabolites
- 3. Clinical utility and quantitation of vitamin D and its metabolites by LC-MS/MS
- 4. Conclusions
Chapter 10: Steroid hormones
- Abstract
- 1. Steroid hormone applications for clinical use
- 2. Calibration and quality control requirements
- 3. Sample preparation
- 4. Instrumentation
- 5. Validation
- 6. Postimplementation Monitoring
- 7. Preanalytical considerations
- 8. Postanalytical considerations
- Disclaimer
Chapter 11: Mass spectrometry in the clinical microbiology laboratory
- Abstract
- 1. Introduction
- 2. How MALDI-TOF MS works
- 3. Commercial systems
- 4. Bacteriology
- 5. Mycobacteriology
- 6. Mycology
- 7. Other Possible MALDI-TOF MS Applications
- 8. Other MS technologies
- 9. Summary and Conclusions
Chapter 12: High resolution accurate mass (HRAM) mass spectrometry
- Abstract
- 1. Introduction
- 2. HRMS fundamentals
- 3. Clinical and forensic toxicology
- 4. Microbiology
- 5. Molecular diagnostics
- 6. Future HRMS clinical applications and developments
- 7. Conclusions
Chapter 13: Evolving platforms for clinical mass spectrometry
- Abstract
- 1. Introduction
- 2. Triple quadrupole
- 3. Quadrupole-time of flight (TOF) and TOF
- 4. Ion trap and orbitrap
- 5. MALDI-TOF
- 6. Hybrid instruments
- 7. PCR-MS
- 8. Front end—sample preparation and collection/ambient ionization/real time analysis
- 9. Ambient and direct ionization approaches
- 10. Imaging MS
- 11. DESI imaging
- 12. Ion mobility mass spectrometry
- 13. Proteomics
- 14. Future implications
Index

Hari Nair

Dr. Nair received his PhD in 1998 under the advice of Prof. Vicki Wysocki at Virginia Commonwealth University, Richmond, VA with specialization in the study of gas phase dissociation of biomolecules in a mass spectrometer. Since then after an NRC postdoctoral fellowship at the US Army, Aberdeen Proving Grounds, MD he has worked for over a decade in the industry that include the tenures as senior scientist at Applied Biosysems where he participated in the development of novel mass spectrometric instrumentation for biotechnology applications and at Perkin Elmer where he was involved in the development and validation of IVD kits for new born screening and clinical lab testing applications. After completion of fellowship from the Department of Lab Medicine at the University of Washington, Seattle, he received his board certification in Clinical Chemistry by the American Board of Clinical Chemistry in 2014, and is a Fellow of the National Academy of Clinical Biochemistry. After a brief stint as a consultant to toxicology labs, he is currently employed as the technical director at the Boston Heart Diagnostics, Framingham, MA.

Dr. Nair has co-authored several peer reviewed articles, a patent and served as a consulting editor for a med tech text book published by Elsevier.

Affiliations and expertise

Technical Director, Boston Heart Diagnostics, Framingham, MA, USA

William Clarke

William Clarke received his PhD in Analytical Chemistry from the University of Nebraska in Lincoln in 2000, followed by a post-doctoral fellowship in Clinical Chemistry at the Johns Hopkins School of Medicine, ending in 2002. In addition, he received an MBA focused on Medical Services Management from the Carey School of Business at Johns Hopkins in 2007. He is an Associate Professor in the Department of Pathology, as well as the director of both Point-of-Care Testing and Clinical Toxicology for The Johns Hopkins Hospital. Dr. Clarke is board certified in Clinical Chemistry by the American Board of Clinical Chemistry, and is a Fellow of the National Academy of Clinical Biochemistry. Dr. Clarke has published, as author or co-author, over 100 peer-reviewed manuscripts and book chapters. He is the Editor of the book Contemporary Practice in Clinical Chemistry, and the Co-Editor-in-Chief for the journal Practical Laboratory Medicine.

Affiliations and expertise

Associate Professor of Pathology, Johns Hopkins School of Medicine, Johns Hopkins University, Baltimore, MD, USA