Production and certification of four frozen human serum certified reference materials containing creatinine and electrolytes
Production and certification of four frozen human serum certified reference materials containing creatinine and electrolytes
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DOI：
10.1258/acb.2007.007126
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发表时间：
2008-03-01
影响因子：
2.2
通讯作者：
Thomas, Annette
中科院分区：
文献类型：
--
作者：
Barbagallo, Romina P.;Boley, Nick;Thomas, Annette
背景：本文介绍了四种冷冻人血清标准物质(CRM)的制备、分析和定值，这些标准物质中含有肌酐和电解质钙、锂、镁、钾和钠。这些材料的制备提供了这些分析物的浓度，覆盖了目前接受的分析范围。方法：用于认证目的的材料的分析使用了可追溯到一级标准的方法，并可作为参考方法。认证方法包括肌酐的精确匹配同位素稀释校正的液质联用(LC-MS)、电感耦合等离子体光发射光谱(ICPOES)、电感耦合等离子体质谱(ICPMS)和电解质的同位素稀释质谱(ID-ICPMS)。结果：这些认证值的估计不确定度包括来自表征测量的成分，以及可能的不均匀性和长期不稳定的贡献。英国一个主要的外部质量评估计划中的测量结果证实了认证的数值，除了测定特别低浓度的肌酐外，测量结果具有很好的一致性。结论：这些材料旨在供病理实验室和体外诊断(IVD)试剂盒制造商使用，以验证现有常规方法是否符合可追溯的标准，这将促进这些实验室使用的不同方法、仪器和IVD试剂盒之间的协调。
Background: This paper describes the preparation, analysis and certification of four frozen human serum certified reference materials (CRMs) containing creatinine and the electrolytes calcium, lithium, magnesium, potassium and sodium. These materials have been prepared to give concentrations of these analytes that cover the currently accepted analytical range.Methods: The analysis of the materials for certification purposes has been carried out using methodology traceable to primary standards, and which is acceptable as a reference method. The certification methods include liquid chromatography-mass spectrometry (LC-MS) with exact-matching isotope dilution calibration (EM-IDMS) for creatinine, inductively-coupled plasma optical emission spectroscopy (ICP-OES), ICP-MS and isotope-dilution incluctively-coupled plasma mass spectroscopy (ID-ICP-MS) for the electrolytes.Results: The uncertainties estimated for these certified values include a component from the characterization measurements, as well as contributions from possible inhomogeneity and long-term instability. The certified values have been corroborated by measurements obtained in a major UK External Quality Assessment scheme, which have, with the exception of the determination of creatinine at a particularly low concentration, given excellent agreement.Conclusions: The materials are intended for use by pathology laboratories and manufacturers of in vitro diagnostic (IVD) kits for validation of existing routine methodology to a traceable standard, which will promote harmonization between the different methods, instruments and IVD kits used in these laboratories.