A Practical Guide to Implementing Clinical Mass Spectrometry Systems

Mass spectrometry is becoming increasingly popular as an analytical tool in clinical laboratories. The aim of this publication is to provide practical guidance for laboratories on the implementation of mass spectrometry into a clinical service where there might be limited expertise in the technique. This guidance is the author’s personal recommendation based on over ten years’ experience of clinical mass spectrometry.

Throughout the text, examples are given to illustrate issues that a clinical laboratory might encounter. While some examples relate to the field of immunosuppressive drug monitoring, the issues are common and relevant to any clinical application. The guidance provided is also applicable to instrumentation made by any manufacturer.

This practical guide covers topics that range from instrument selection and business planning to installation, risk management and validation, and also includes suggestions for future prospects in this developing field.

Chapter 1 Introduction

Chapter 2 Why Choose Mass Spectrometry?

Chapter 3 Selection of Instrumentation

Chapter 4 Business Planning

Chapter 5 Installation

Chapter 6 Risk Management

Chapter 7 Methodology and Validation

Chapter 8 Standard Operating Procedures

Chapter 9 Future Prospects

Chapter 10 A Blessing and a Curse?

References
Index

Neil Leaver is a clinical scientist with over 30 years’ experience in the National Health Service and 20 years’ experience in the measurement of immunosuppressive drugs used in transplantation.

Following on from an idea developed in 1996, his first mass spectrometer was installed in December 1997 as a development platform for new rapid liquid chromatography–mass spectrometry/mass spectrometry (LC–MS/MS) methods for therapeutic drug monitoring of the immunosuppressive drugs cyclosporin and tacrolimus. In April 1999, following extensive validation and risk analysis, the UK’s first seven-day week MS service for these drugs was introduced. Today the service operates three clinical instruments providing national services to hospitals in the UK and Eire. In addition, the service has a number of research and development programmes: these include new method development and assessing new hardware for suitability for use in clinical diagnostics.