Multicenter Evaluation of Cystatin C Measurement after Assay Standardization
Multicenter Evaluation of Cystatin C Measurement after Assay Standardization
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DOI：
10.1373/clinchem.2016.264325
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发表时间：
2017-04-01
影响因子：
9.3
通讯作者：
Cavalier, Etienne
中科院分区：
文献类型：
--
作者：
Bargnoux, Anne -Sophie;Pieroni, Laurence;Cavalier, Etienne
背景：自2010年以来，cystatin C （CysC）的标准物质ERM-DA471/IFCC已获得认证。本研究旨在评估使用标准化测定法测量临床样品结果不确定性的来源。方法：该评估于2015年进行，涉及位于法国和比利时的7个临床实验室。CysC在4个血清池中使用8种自动检测方法和候选同位素稀释质谱参考测量程序进行检测。评估不确定度（不精确和偏倚）的来源，以计算每个CysC测定的相对扩展组合不确定度。根据生物变异模型得出的性能指标来判断不确定性。结果：只有Siemens试剂在Siemens系统上提供的结果符合根据个体内和个体间生物学差异计算的最低性能标准，而DiaSys试剂在Cobas系统上提供的结果也有较小程度的满足。尽管几乎所有的检测方法都可以接受不精确，但在龙胆试剂中观察到偏差随着浓度的增加而增加，而在雅培和罗氏试剂自己的系统中观察到不可接受的高偏差。结论：自ERM-DA471/IFCC发布以来的市场情况的全面图景表明，由于与可追溯性实施相关的可能问题，偏差仍然是综合不确定性的主要组成部分。尽管一些制造商已经明确地改进了相对于ERM-DA471的校准协议，但大多数制造商未能满足可接受的CysC测量标准。(C) 2016美国临床化学协会。
BACKGROUND: Since 2010, a certified reference material ERM-DA471/IFCC has been available for cystatin C (CysC). This study aimed to assess the sources of uncertainty in results for clinical samples measured using standardized assays.METHODS: This evaluation was performed in 2015 and involved 7 clinical laboratories located in France and Belgium. CysC was measured in a panel of 4 serum pools using 8 automated assays and a candidate isotope dilution mass spectrometry reference measurement procedure. Sources of uncertainty (imprecision and bias) were evaluated to calculate the relative expanded combined uncertainty for each CysC assay. Uncertainty was judged against the performance specifications derived from the biological variation model.RESULTS: Only Siemens reagents on the Siemens systems and, to a lesser extent, DiaSys reagents on the Cobas system, provided results that met the minimum performance criterion calculated according to the intraindividual and interindividual biological variations. Although the imprecision was acceptable for almost all assays, an increase in the bias with concentration was observed for Gentian reagents, and unacceptably high biases were observed for Abbott and Roche reagents on their own systems.CONCLUSIONS: This comprehensive picture of the market situation since the release of ERM-DA471/IFCC shows that bias remains the major component of the combined uncertainty because of possible problems associated with the implementation of traceability. Although some manufacturers have clearly improved their calibration protocols relative to ERM-DA471, most of them failed to meet the criteria for acceptable CysC measurements. (C) 2016 American Association for Clinical Chemistry.