IFCC SCIENTIFIC DIVISION (SD) � AN UPDATE OF THE ONGOING
ACTIVITIES RELATED TO STANDARDIZATION

As a general rule, the SD initiates and manages projects through its Committees (C) and Working Groups (WG). The Cs are theme orientated, and typically carry out a range of projects in an area of particular importance to the laboratory medicine community. WGs are task orientated and focus on a single goal or closely related set of goals which can usually be achieved in a limited timescale. The SD currently coordinates the activities of eight Cs and thirteen WGs.
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The majority of C/WGs are involved, in collaboration with the IVD industry and with other organizations such as IRMM and NIST, in developing reference measurement systems (i.e. reference methods, reference materials and reference laboratories) for measurands of clinical significance to reduce whenever possible measurement uncertainty and to promote comparability of results for a better reliability of the information obtained from routine procedures.

To illustrate the complexity and the impact of these activities on patient care, the work of C/WGs related to the standardization of some analytes is briefly summarized in this editorial. The Committee on Plasma Proteins (C-PP) is currently carrying out work on the development of a new commutable reference material for protein analysis as a substitute of the first CRM 470, which is now selling out. The C-PP is also closely monitoring emerging technologies in the field of proteomics with a view to producing guidance on standardisation and clinical utility of these methodologies at an appropriate stage. The Committee on Standardisation of Markers of Cardiac Damage (C-SMCD) has a broad remit to produce analytical and clinical recommendations pertaining to standardisation and evaluation of available and newly introduced biomarker assays. Joint NACB-IFCC guidelines on standardization of markers of cardiac damage have been updated this year, and C-SMCD is currently working on the development of a troponin I reference system and on the characterization of B-type natriuretic peptide assays. The Committee on Reference Systems of Enzymes (C-RSE), after the development and publication of six reference methods for clinically relevant enzymes, is currently focussing on the development of IFCC reference methods for alkaline phosphatase and pancreatic lipase. The C-RSE has also created a reference laboratory network, which has demonstrated its competence to certify reference materials (an ongoing activity concerns the certification of a new reference material for aspartate aminotransferase in cooperation with IRMM).  The Committee on Reference Intervals and Decision Limits (C-RIDL) is promoting a standardised approach to establish common reference intervals obtained using methods traceable to validated reference systems. In particular, the C-RIDL is organizing a multicentre determination of reference intervals for aspartate aminotransferase, alanine aminotrasferase and g-glutamyltransferase, involving three IFCC reference laboratories and a number of clinical laboratories worldwide located. The C-RIDL liaises closely with the Committee on Traceability in Laboratory Medicine (C-TLM), which supports all SD activities with respect to the implementation of the concept of traceability and, specifically, is responsible of the IFCC External Quality Assessment Scheme (EQAS) created to demonstrate the competence of reference laboratories as reference measurement service providers.  Finally, the Committee on Molecular Diagnostics (C-MD) has developed criteria for IFCC molecular diagnostics expert laboratories and network laboratories, and invited applications from interested laboratories via national societies. A number of applications are currently being considered and it is hoped that networks with expertise in various areas of molecular diagnostics will be established later this year. Applications from further interested laboratories will be invited on an ongoing basis. 

In the last ten years, the WG on Standardization of HbA1c (WG-HbA1c) has successfully developed a reference system for this measurand. It is now developing an implementation program to educate laboratory professionals and clinicians about the importance of international standardisation of HbA1c measurements for the benefit of diabetic patients. The activities of this WG are likely to be of major importance to the laboratory community, clinicians and patients. Importantly, a joint agreement has been reached between the IFCC and the international diabetologists associations (ADA, EASD, IDF) to recommend acceptance of the IFCC reference system as the international foundation for HbA1c measurement, to issue results in both SI (mmol/mol) and traditional (%) units, and to assess the suitability of reporting an �estimated average plasma glucose� when validation by clinical data is available. The WG on Standardisation of Thyroid Function Tests (WG-STFT) has published this year two papers on the definition of free T4 as a measurand and on a candidate international conventional reference method for free T4 measurement in serum. An inter-laboratory comparison using this methodology will be performed later this year. The WG-STFT is also discussing the issue of TSH standardization and considering alternative approaches to this as a future activity. The WG on Standardisation of Glomerular Filtration Rate Assessment (WG-GFRA) is developing further recommendations for creatinine measurement and accurate GFR estimation.   Hemoglobin A2, carbohydrate-deficient transferrin (CDT), cystatin C, urinary albumin, and growth hormone (hGH) are further markers for which specific SD WGs are pursuing standardization through the creation of specific reference systems. Finally, in view of the substantial differences which exist in commercially available insulin assays, a WG on the Standardization of Insulin Assays (WG-SIA) has been jointly established with the American Diabetes Association and is currently developing a candidate reference method for insulin analysis. 

As can be seen from this brief update, the work of the SD stretches across the full remit of Laboratory Medicine and seeks to address the issues of greatest importance to the profession, laboratory users and patients.  Members of the SD are always happy to discuss ongoing or future projects with interested parties and suggestions as to other areas which the SD might address in the future are welcome.