Progress towards standardization: an IFCC Scientific Division Perspective.

The aim of the Scientific Division (SD) of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) is to advance the science of Laboratory Medicine [ 1 ]. In this regard, IFCC-SD identifies research areas of relevance in Laboratory Medicine and related scientific and technological problems, and provides solutions and guidelines on how to resolve them. Especially, SD focuses on standardization issues in order to facilitate the development and implementation of new methods and their optimal use in clinical practice. To facilitate its work, IFCC-SD has established over time a number of committees (Cs) and working groups (WGs) devoted to various areas of Laboratory Medicine. In most cases, the outcome has been the description of reference measurement procedures (RMPs) and the validation of certified and commutable reference materials [ 1 ]. The list of active Cs and WGs in 2012 is shown in Table 1 . Standardization of methods is a complex process which requires the development of a full reference measurement system and a traceability chain. For some measurands, the path from description of a RMP to implementation of standardized tests in clinical laboratories is a long and complex one. In this special issue, several Cs or WGs provide state-of-the art reviews or experimental data illustrating the different steps of the standardization process and the potential difficulties encountered. Metrological traceability is a major concept in SD ’ s strategy for standardization, which aims at obtaining equivalent measurement results regardless of the assay. This implies traceability to RMPs through an unbroken chain of steps, each contributing to the measurement uncertainty [ 2 ]. In addition, since the use of an agreed terminology is needed to ensure the correct reporting of results generated by specialists in Laboratory Medicine to clinicians, definition and update of metrological terms and units are major roles of the Joint Committee for Nomenclature, Properties and Units of the IFCC and The International Union of Pure and Applied Chemistry (IUPAC) (C-NPU) [ 3 ]. Many efforts of SD WGs are devoted to the establishment of RMPs and of convenient commutable reference materials. In this issue, the example of the development and the validation of a candidate LC-MS/MS RMP for urinary albumin is described by the Working Group on Standardization of Albumin Assays in Urine (WG-SAU), together with the validation of candidate reference materials for urinary albumin and creatinine [ 4 ]. As highlighted in this paper, the availability of such procedures and materials will enable standardization of this important marker of kidney damage and risk factor for progression of renal and cardiovascular diseases. Another example is given with carbohydrate-deficient transferrin (CDT), a clinically relevant biomarker of alcohol abuse, by the WG-CDT. While an HPLC candidate reference method has already been proposed, the availability of convenient secondary reference materials is now necessary for harmonizing CDT measurements by different methods before achieving their full standardization against the RMP [ 5 ]. However, achieving full standardization is challenging and various pitfalls may occur along the path from RMP to routine practice. A major practical difficulty, the sourcing of relevant clinical samples for establishing metrological traceability, is discussed in this issue [ 6 ]. The experience of the Working Group on Standardization of Thyroid Function Tests (WG-STFT, since transformed into a Committee) in obtaining relevant panels from normal and non-euthyroid patients illustrates the difficulty of collecting sufficient numbers of samples from patients covering the whole range of clinical interest while adhering to approved ethical and regulated procedures. This experience demonstrates that those leading similar projects should collaborate with both manufacturers and clinicians to allow the constitution of sample panels which could support the efforts of method standardization. Another challenge is related to the transfer of new methods from basic research laboratories to clinical laboratories. This is especially the case for quantitative mass spectrometry, which is entering the field of Laboratory Medicine after having been a major tool of structural investigation in basic research, especially