Sergio Caroli and Gyula Záray: Analytical techniques for clinical chemistry: methods and applications

Abstract

At 800 pages, this is a doorstop of a book, containing contributions by 64 authors from 14 countries. So, first must be a word of congratulation to the editors for managing such a work that addresses their perceived need for an analytical text in clinical chemistry. This review cannot do justice to the 25 chapters, but it will try to give an overview of the book, dip into some of the offerings, and suggest its place in the literature of the field. The back-cover blurb suggests the book deals with the role of analytical chemistry in ‘‘fostering clinical research’’. So, the perspective is clearly on using analytical chemistry as a means to a number of ends. The branch of chemistry dealing with measurements in clinical science has often led to developments in instrumentation and stimulated wider metrological thinking in analytical chemistry. The need for safety of pharmaceuticals, adherence to regulations, production of timely results for clinicians and patients, and the need to measure ever tinier amounts of obscure compounds in more complex systems put a great task on clinical analytical chemists. It is not surprising that the first chapter in the section ‘‘Exploring Fundamentals’’ is titled ‘‘Good Clinical Practice Principles: Legal Background and Applicability’’. Here is detailed the major standards around Good Clinical Practice from ICH, WHO, and a number of EC directives. As a member of the Joint Committee for Guides on Metrology, Working Group 1 (the group responsible for the Guide to the Expression of Uncertainty in Measurement, GUM [1]), I was particularly interested in the chapter on uncertainty. The authors correctly use definitions from the International Vocabulary of Metrology, VIM [2], which puts the chapter on a sound metrological footing, unlike chapter 9.3 (Validation of Analytical Methods) which appears not have heard of VIM. The GUM is also referenced here, and the problem of ‘‘pre-analytical uncertainty’’ is raised. The chapter as a whole reads more of one addressing general quality issues than simply uncertainty, with sections on method validation, proficiency testing, and reference intervals. There is a tendency to make up quantities and symbols. SE here is short for systematic error, which most statisticians would read as ‘‘standard error’’. Two-letter acronyms abound when, in my opinion, the English words could appear certainly in the text. The space saved by ‘‘CM’’ over ‘‘control material’’ does not make up for the interruption to the reader’s flow, and the proper symbol in equations for standard deviation is s not SD. With all the extraneous, but interesting, material in this chapter, I am not sure whether a reader would be able to estimate a measurement uncertainty for a particular clinical measurement result. This chapter is a good example of the difference in outlook of, if I can call them thus, chemical analytical chemistry and clinical analytical chemistry, the former focusing on measurement, and the latter on process and the system as a whole. The last chapter in the Fundamentals section, on metal toxicology, seems out of place and perhaps should have been in the next section on Selected Applications, while chapter 8 on the role of analytical chemistry in the safety of drug therapy could perhaps have come into Fundamentals. The metals chapter could then have been put next to the chapter on molybdenum. In this section, the chapter of drug detection for antidoping controls caught my attention. This chapter is a nice essay on the state of play with reference to the major substances administered illicitly (EPO, steroids, growth hormones, and the plethora of agonists and antagonists). D. B. Hibbert (&) School of Chemistry, University of New South Wales, Sydney, NSW 2052, Australia e-mail: b.hibbert@unsw.edu.au