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Commutability of reference materials for alkaline phosphatase measurements.
Scandinavian Journal of Clinical and Laboratory Investigation ( IF 1.3 ) Pub Date : 2020-04-09 , DOI: 10.1080/00365513.2020.1747111
Qi Guo 1, 2, 3 , Jing Wang 1, 3 , Xilian Yi 1, 2, 3 , Jie Zeng 1, 3 , Weiyan Zhou 1, 3 , Haijian Zhao 1, 3 , Tianjiao Zhang 1, 3 , Chuanbao Zhang 1, 2, 3
Affiliation  

Commutability is a prerequisite when using a candidate reference materials (CanRMs) for calibration and trueness control of routine methods or for value transfer from the reference method to end-user calibrators of routine methods through a calibration hierarchy. The CanRMs include commercial general chemistry materials (GCs), enzyme trueness verification materials (ETVs), and secondary reference materials (SRMs). The commutability of CanRMs was evaluated based on the difference in bias and EP14-A3 to investigate their suitability for ALP measurement. A total of 44 fresh individual clinical samples (CSs) and the CanRMs were analyzed by six routine methods (validated methods) and by IFCC primary reference method (comparative method) for the determination of Alkaline Phosphatase (ALP). The commutability was performed based on IFCC working group recommendations for assessing commutability and analyzed according to EP14-A3 guide and difference in bias approach, respectively. The bias of the routine methods was assessed according to CLSI guidelines. The result of commutable materials obtained from the two evaluation approaches are not significantly different. It was observed that the routine methods with lower bias were associated with more commutable CanRMs. None of the CanRMs were suitable for use as commutable RMs. The findings of this study have a number of important implications for future practice.



中文翻译:

用于碱性磷酸酶测定的参考物质的可交换性。

当使用候选参考材料(CanRM)进行常规方法的校准和真实性控制,或通过校准层次结构将值从参考方法传递到常规方法的最终用户校准器时,可交换性是前提条件。CanRM包括商业通用化学材料(GC),酶真实性验证材料(ETV)和二级参考材料(SRM)。根据偏倚和EP14-A3的差异评估CanRM的可交换性,以研究其对ALP测量的适用性。通过六种常规方法(验证方法)和IFCC主要参考方法(比较方法)对总共44份新鲜的单个临床样品(CS)和CanRM进行了分析,以确定碱性磷酸酶(ALP)。可交换性是根据IFCC工作组关于可交换性的建议进行的,并分别根据EP14-A3指南和偏差方法进行了分析。根据CLSI指南评估常规方法的偏倚。从两种评估方法获得的可交换材料的结果没有显着差异。观察到,偏倚较低的常规方法与可交换的CanRMs相关。没有一个CanRM适合用作可交换RM。这项研究的发现对未来的实践具有许多重要的意义。从两种评估方法获得的可交换材料的结果没有显着差异。观察到,偏倚较低的常规方法与可交换的CanRMs相关。没有一个CanRM适合用作可交换RM。这项研究的发现对未来的实践具有许多重要的意义。从两种评估方法获得的可交换材料的结果没有显着差异。观察到,偏倚较低的常规方法与可交换的CanRMs相关。没有一个CanRM适合用作可交换RM。这项研究的发现对未来的实践具有许多重要的意义。

更新日期:2020-04-09
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