Division of Chemical Metrology and Analytical Science, National Institute of Metrology (Key Laboratory of Chemical Metrology and Applications on Nutrition and Health for State Market Regulation), Beijing, P.R. China.
School of Chemical Engineering, Beijing University of Chemical Technology, Beijing, P.R. China.
Clin Chem Lab Med. 2022 Aug 18;60(10):1562-1569. doi: 10.1515/cclm-2022-0388. Print 2022 Sep 27.
Commutability of reference materials is essential for ensuring the traceability of patient measurement results and the technical basis for the use of reference materials. Commutability is only relevant for matrixed reference material; it is a prerequisite for the accuracy and authenticity of calibration methods. In this study, we evaluated the commutability of reference materials for homocysteine.
Five conventional measurement methods were applied to simultaneously measure 30 serum samples and seven homocysteine reference materials from the National Institute of Standards and Technology and the National Institute of Metrology. Liquid chromatography tandem-mass spectrometry was used as a reference method. Two methods were used to evaluate the commutability of the seven reference materials according to the Clinical and Laboratory Standards Institute EP30-A and the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) commutability assessment document.
Among 35 combinations of the five conventional methods and seven reference materials, after evaluation in accordance with the EP30-A, the seven reference materials passed the commutability assessment, and 34 combinations were commutable. According to the IFCC, the commutability evaluation of 28 combinations was conclusive (commutable or non-commutable), while results for the remaining seven combinations could not be determined.
The homocysteine reference materials showed good commutability. The sensitivity of the measurement procedure, measurement deviation and uncertainty, and differences in the "measurand" selected by different methods may affect the evaluation results. Additionally, different judgment standards for different methods may explain the observed variations in evaluation results.
参考物质的互换性对于确保患者测量结果的溯源性以及参考物质使用的技术基础至关重要。互换性仅与基质参考物质有关；它是校准方法准确性和真实性的前提。本研究评估了同型半胱氨酸参考物质的互换性。
应用五种常规测量方法同时测量来自美国国家标准与技术研究院和中国计量科学研究院的 30 个血清样本和七种同型半胱氨酸参考物质。液相色谱串联质谱法被用作参考方法。根据临床和实验室标准协会 EP30-A 和国际临床化学和实验室医学联合会（IFCC）的互换性评估文件，使用两种方法来评估七种参考物质的互换性。
在五种常规方法和七种参考物质的 35 种组合中，经过 EP30-A 评估，七种参考物质均通过了互换性评估，其中 34 种组合具有互换性。根据 IFCC，28 种组合的互换性评估具有结论性（可互换或不可互换），而其余七种组合的结果无法确定。
同型半胱氨酸参考物质具有良好的互换性。测量程序的灵敏度、测量偏差和不确定度以及不同方法选择的“待测物”差异可能会影响评估结果。此外，不同方法的不同判断标准可能解释了评估结果的观察到的变化。
