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  • Title: [Study on commutability evaluation of reference materials for fibrinogen].
    Author: Liu YH, Li CB, Zhou WB, Peng MT.
    Journal: Zhonghua Yi Xue Za Zhi; 2019 Jul 09; 99(26):2062-2067. PubMed ID: 31315378.
    Abstract:
    Objective: To discuss the commutability evaluation method of reference materials for fibrinogen measurement and evaluate the commutability of the Third WHO International Standard Fibrinogen Plasma (WHO 09/264), SSC/ISTH Secondary Coagulation Standard (SSC LOT4) and homemade reference materials (RM01, RM02) in order to provide suggestions on how to determine the suitable method of commutability evaluation and reliable traceability standard. Methods: The comparability of fibrinogen among different measurement systems were evaluated and WHO 09/264 was used to calibrate each system to improve the comparability if the comparability among different systems couldn't be accepted. Forty clinical samples and the reference materials randomly interspersed among the clinical samples were measured on Stago STA-R Evolution, Sysmex CS 5100, IL ACL TOP 700 simultaneously. Measurement results were pairwise analyzed by Deming regression and difference in bias approach according to the Clinical and Laboratory Standards Institute (CLSI) EP14-A3 protocol and the recommendations of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) working group on commutability, respectively. Results: The comparability of fibrinogen measurement among common systems could not meet the criterion. WHO 09/264 could improve the agreement among different measurement systems. The prediction interval of Deming regression was affected by the comparability of measurement systems, resulting in unreliable results. The difference in bias approach was more suitable because its criterion was related to the medical requirements. WHO 09/264 was commutable between Stago and Sysmex, inconclusive between Stago and IL, Sysmex and IL (The calibration effectiveness of WHO 09/264 showed that it was commutable among the three measurement systems). SSC LOT4 was commutable between Stago and Sysmex, inconclusive between Stago and IL, Sysmex and IL. RM01 and RM02 were commutable between all systems pairs assessed by difference in bias approach. Conclusions: There are differences in the results of two commutability evaluation approaches. The difference in bias approach is recommended for commutability evaluation. WHO International Standard and homemade reference materials can be used as traceability standard for fibrinogen measurement. 目的： 探讨纤维蛋白原（Fib）检测参考物质的互通性评价方法，评价Fib检测WHO国际标准品（WHO 09/264）、国际血栓与止血协会科学标准化委员会（SSC/ISTH）凝血标准品（SSC LOT4）及自制参考物质（RM01和RM02）的互通性，为实验室合理选择互通性评价方法及可靠的溯源标准提供参考。 方法： 评价国内常用检测系统Fib检测结果的可比性，若可比性不满足要求，使用WHO 09/264为各检测系统校准以改进可比性。在可比性满足要求的基础上，将待评价参考物质随机穿插于40例临床样本间，在Stago STA-R Evolution、Sysmex CS 5100、IL ACL TOP 700共3个系统上同时进行检测。参考美国临床实验室标准化协会（CLSI）指南文件EP14-A3和国际临床化学和检验医学联合会（IFCC）互通性评价工作组的推荐，分别采用Deming回归法及偏差差值评估法评价参考物质的互通性。 结果： 常用检测系统间Fib检测结果可比性无法满足要求，WHO国际标准品可改进检测系统间的可比性。Deming回归法互通性评价的允许范围受检测系统可比性影响，评价结果不可靠。偏差差值评估法考虑了临床需求，是一种更加合理的互通性评价方法。偏差差值评估法参考物质互通性评价结果显示，WHO 09/264在Stago和Sysmex两个检测系统间具有互通性，在Stago和IL两个检测系统间、Sysmex和IL两个检测系统间的互通性难以确定（WHO 09/264的校准效果表明，其在3个检测系统间的互通性符合要求）；SSC LOT4在Stago和Sysmex两个检测系统间具有互通性，在Stago和IL两个检测系统间、Sysmex和IL两个检测系统间的互通性难以确定；RM01、RM02在3个检测系统间均具有互通性。 结论： 两种互通性评价方法的评价结果存在差异，推荐使用偏差差值评估法评价参考物质的互通性。WHO国际标准品和自制参考物质可作为Fib检测的溯源标准。.
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