The book on practical aspects of clinical MS is written by Neil Leaver, who is a clinical scientist with expertise in LC–MS. It has been written with an objective of implementing MS into clinical services, with the criteria of not highlighting any particular vendor or equipment. Examples are included to cover issues related to a clinical laboratory.
The book is divided into ten chapters. The introduction to clinical MS in chapter one debates the real meaning of the title. The author has argued that there is no specific instrument designed for clinical applications, it is more about the applications themselves.
Chapter two covers the reasons for choosing MS for clinical samples. The ability of LC–MS to provide specific, highly sensitive analysis, with the need for small sample requirements makes it a desirable option. Issues such as slower speed of LC–MS, high capital cost and the need for specialized training as compared with commercial immunoassays have been discussed. Chapter three provides an insight into instrumentation. Between two main technologies (i.e., triple quadrupole vs ion trap), the author recommends the former, even though it is the costlier option. In terms of sources of ionization, an ESI source is typically provided as the default, while APCI is an add on. Selection of HPLC is equally critical; it is recommended to choose a HPLC pump with a small dead volume. Simplicity of the software and ease of adaptation by multiple users is of great advantage, as is the system support, maintenance, availability of consumables, service and parts. Chapter four concerns business planning to procure the equipment. The options for new capital investment include lease, rental or purchase. Provision of sufficient funding to cover facility requirements such as air conditioning, equipment qualifications and running costs should also be made. In addition, the risk management costs for analytical backup systems or additional assay systems, and the costs for maintaining stocks of consumable and spare parts and training should also be accounted for.
Chapter five covers the preparation and process of installation. The requirements for power supply, sockets and circuits, air conditioning, nitrogen source and the resulting noise levels, collision gas, safe removal of waste solvent and oil, and uninterruptible powers supply (3–5 KVA units recommended) have been highlighted. The installation process can last from 2 to 3 days. The author has raised an important issue about validation of the system by engineers, which is not a common practice. From my experience with good laboratory practice, this should be negotiated and agreed upon with the vendor before placing the order. Risk management is the focus of the next chapter, addressing issues such as handling equipment failure, linkage with computer networks and laboratory management information systems, consumable stocks, training, action plan for worst case scenarios and service support.
Developing a method and validation can be a demanding exercise, therefore, 3 to 6 months should be allocated for any new LC–MS method. The author has advocated purchasing both ESI and APCI sources in the new instrument specifications. Sample volume is a critical parameter with clinical samples and has to balance availability of samples, measurement capabilities and the assay sensitivity. Some of the practical aspects of assay development such as extraction method, choice of HPLC method, column selection, ion suppression, assay validation and internal standards are discussed in chapter seven. The information provided in this chapter equates to a ‘practical tips’ guide and readers will have to refer to standard texts such as ICH guidelines for further details.
The need for comprehensive documentation, especially in the case of multiskilled laboratories, is presented in chapter eight on the subject of SOPs. The example provided in figure 8.1 is a user-friendly example of an instrument and assay specific daily maintenance sheet, which can be adapted to any environment.
The author has made a good effort in making some recommendations in chapter nine, including the need for developing a clinical MS platform, easier software and technical support.
Overall, I found this book to be an interesting read, especially for people considering the use of LC–MS for clinical sample analysis. It has been written from a very practical point of view, covering subject matter that is usually learned through experience and is not discussed in standard texts or regulatory guidelines. This could be a valuable reference book for clinical laboratories.
Financial & competing interests disclosure
The author has no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.
No writing assistance was utilized in the production of this manuscript.