Liu Y H, Li C B, Zhou W B, Peng M T
Graduate School of Peking Union Medical College, National Center for Clinical Laboratories, Beijing Engineering Technology Center of Clinical Laboratory, Beijing Hospital, National Center of Gerontology, Beijing 100730, China.
National Center for Clinical Laboratories, Beijing Engineering Technology Center of Clinical Laboratory, Beijing Hospital, National Center of Gerontology, Beijing 100730, China.
Zhonghua Yi Xue Za Zhi. 2019 Jul 9;99(26):2062-2067. doi: 10.3760/cma.j.issn.0376-2491.2019.26.012.
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. 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. 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. 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.
探讨纤维蛋白原检测参考物质的互换性评估方法，并评估世界卫生组织第三国际标准纤维蛋白原血浆（WHO 09/264）、SSC/ISTH二级凝血标准品（SSC LOT4）及自制参考物质（RM01、RM02）的互换性，以便为如何确定合适的互换性评估方法及可靠的溯源标准提供建议。评估不同检测系统间纤维蛋白原的可比性，若不同系统间的可比性不能接受，则使用WHO 09/264校准各系统以提高可比性。将40份临床样本及随机穿插于临床样本中的参考物质同时在Stago STA-R Evolution、Sysmex CS 5100、IL ACL TOP 700上进行检测。测量结果分别根据临床和实验室标准协会（CLSI）EP14-A3协议及国际临床化学和检验医学联合会（IFCC）互换性工作组的建议，采用Deming回归和偏差差异法进行两两分析。常见系统间纤维蛋白原检测的可比性未达到标准。WHO 09/264可提高不同检测系统间的一致性。Deming回归的预测区间受检测系统可比性的影响，结果不可靠。偏差差异法更合适，因为其标准与医学要求相关。WHO 09/264在Stago和Sysmex之间具有互换性，在Stago和IL、Sysmex和IL之间不确定（WHO 09/264的校准有效性表明其在三种检测系统间具有互换性）。SSC LOT4在Stago和Sysmex之间具有互换性，在Stago和IL、Sysmex和IL之间不确定。RM01和RM02在通过偏差差异法评估的所有系统对之间具有互换性。两种互换性评估方法的结果存在差异。建议采用偏差差异法进行互换性评估。WHO国际标准品和自制参考物质可作为纤维蛋白原检测的溯源标准。
