Commutability study on three CRMs evaluating their suitability for calibration, trueness verification and statistical quality control of methods measuring metal concentrations in human blood.

IF 3.8 2区 化学 Q1 BIOCHEMICAL RESEARCH METHODS Analytical and Bioanalytical Chemistry Pub Date : 2025-02-04 DOI:10.1007/s00216-025-05751-0
Thomas P J Linsinger, Guy Auclair, Liesbet Deprez
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Abstract

The commutability of three certified reference materials for Cd, Cr, Hg, Ni, Pb and Tl in blood was evaluated for the combination of digestion ICP-MS with dilution ICP-MS or dilution GFAAS using the difference in bias approach. Maximum non-commutability bias (MANCB) was derived from the median of the tolerance limits set by six proficiency testing (PT) providers. The evaluation showed that this criteria are too strict and that either unfeasible high number of measurements or a larger MANCB is required to demonstrate commutability. The effect of increasing the MANCB on the maximum tolerable measurement uncertainty was found small to moderate demonstrating the commutability of the materials when used as a calibrator. Also the inclusion of the uncertainty of non-commutability into the measurement uncertainty resulted in only small increases of the measurement uncertainty, demonstrating the suitability of the materials for trueness control and method validation. The bias of the three CRMs was for most elements within the 99% confidence limits of the bias of the patient samples, demonstrating the suitability of the materials for statistical quality control.

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采用偏差差法评估了血液中 Cd、Cr、Hg、Ni、Pb 和 Tl 的三种认证标准物质与消化 ICP-MS 和稀释 ICP-MS 或稀释 GFAAS 的组合的互换性。最大不可通约性偏差 (MANCB) 是根据六家能力测试 (PT) 提供商设定的容许偏差限的中位数得出的。评估结果表明,这一标准过于严格,要证明可互换性,要么需要大量的测量,要么需要更大的 MANCB。增加 MANCB 对最大可容忍测量不确定度的影响很小到中等,这表明材料在用作校准器时具有互换性。此外,将非互换性的不确定性纳入测量不确定性只会导致测量不确定性的小幅增加,这表明材料适用于真实性控制和方法验证。对于大多数元素来说,三种有证标准物质的偏差都在患者样本偏差的 99% 置信限内,这表明这些材料适合用于统计质量控制。
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来源期刊
CiteScore
8.00
自引率
4.70%
发文量
638
审稿时长
2.1 months
期刊介绍: Analytical and Bioanalytical Chemistry’s mission is the rapid publication of excellent and high-impact research articles on fundamental and applied topics of analytical and bioanalytical measurement science. Its scope is broad, and ranges from novel measurement platforms and their characterization to multidisciplinary approaches that effectively address important scientific problems. The Editors encourage submissions presenting innovative analytical research in concept, instrumentation, methods, and/or applications, including: mass spectrometry, spectroscopy, and electroanalysis; advanced separations; analytical strategies in “-omics” and imaging, bioanalysis, and sampling; miniaturized devices, medical diagnostics, sensors; analytical characterization of nano- and biomaterials; chemometrics and advanced data analysis.
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