Progress towards standardization: an IFCC Scientific Division Perspective
Progress towards standardization: an IFCC Scientific Division Perspective
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标准化进展：IFCC 科学部门的视角
DOI：
10.1515/cclm-2013-0081
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发表时间：
2013
期刊：
影响因子：
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通讯作者：
I. Young
中科院分区：
文献类型：
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作者：
P. Gillery;I. Young
国际临床化学和检验医学联合会(IFCC)科学部(SD)的目标是推进检验医学的科学[1]。在这方面，IFCC-SD确定了与检验医学相关的研究领域和相关的科学和技术问题，并就如何解决这些问题提供了解决方案和指导方针。尤其是，SD侧重于标准化问题，以促进新方法的开发和实施及其在临床实践中的最佳使用。为了促进其工作，IFCC-SD随着时间的推移建立了一些委员会(C)和工作组(WG)，专门研究实验室医学的各个领域。在大多数情况下，结果是对参考测量程序(RMP)的描述以及对经认证的和可交换的参考材料的验证[1]。表1列出了2012年的活性Cs和WG。方法的标准化是一个复杂的过程，需要开发一个完整的参考测量系统和可追溯链。对于一些被测量的国家，从描述RMP到在临床实验室实施标准化测试是一条漫长而复杂的道路。在本期特刊中，几个C或WG提供了最新的回顾或实验数据，说明了标准化进程的不同步骤和遇到的潜在困难。计量溯源是SD‘S标准化战略中的一个主要概念，其目标是获得同等的测量结果，而不考虑化验。这意味着可以通过不间断的步骤链追溯到RMP，每个步骤都会造成测量不确定度[2]。此外，由于需要使用商定的术语来确保向临床医生正确报告检验医学专家产生的结果，计量术语和单位的定义和更新是IFCC和国际理论和应用化学联合会(IUPAC)的命名、性质和单位联合委员会的主要作用[3]。可持续发展工作组致力于制定制冷剂管理计划和方便通俗的参考材料。在本期中，尿白蛋白检测标准化工作组(WG-SAU)描述了尿白蛋白候选LC-MS/MS RMP的开发和验证的实例，以及尿白蛋白和肌酐的候选参考物质的验证[4]。正如本文所强调的，这些程序和材料的可获得性将使这一肾脏损害的重要标志和肾脏和心血管疾病进展的危险因素标准化。另一个例子是WG-CDT提供的碳水化合物缺乏转铁蛋白(CDT)，这是一种与酒精滥用有关的临床生物标志物。虽然已经提出了一种候选的高效液相参比方法，但现在需要方便的二次参比物质来协调不同方法的CDT测量，然后才能实现与RMP的完全标准化[5]。然而，实现完全标准化是具有挑战性的，在从RMP到常规实践的过程中可能会出现各种陷阱。一个主要的实际困难，相关的临床样本的来源，以建立计量可追溯性，在这一问题中讨论[6]。甲状腺功能测试标准化工作组(WG-STFT，后来转变为一个委员会)在从正常和非正常甲状腺患者那里获得相关样本方面的经验表明，在遵循经批准的道德和监管程序的同时，从涵盖所有临床利益的患者那里收集足够数量的样本是困难的。这一经验表明，那些领导类似项目的人应该与制造商和临床医生合作，允许建立支持方法标准化工作的样本板。另一个挑战涉及将新方法从基础研究实验室转移到临床实验室。尤其是定量质谱学，它在成为基础研究中结构研究的主要工具之后，正在进入实验室医学领域，特别是
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