Abstract：
The Joint Committee for Traceability in Laboratory Medicine (JCTLM) currently lists the secondary commutable certified reference material (CRM) ERM DA-474/IFCC (DA-474) \"C-Reactive Protein in Human Serum\" and two generic immunoassay-based method principles as the basis for implementing the metrological traceability of C-reactive protein (CRP) measurements by end-user measurement procedures used by medical laboratories. The current metrological traceability has produced well harmonized results for clinical samples among different end-user measurement procedures. New higher-order pure substance and secondary commutable CRMs have been nominated for listing by the JCTLM. However, the data supporting performance of these new candidate CRMs, including use of new mass spectrometry based candidate reference measurement procedures (RMPs), was not clear regarding the influence that introducing these new CRMs would have on the current well harmonized results achieved with the existing metrological traceability to DA-474. The clinically relevant CRP measurand in blood serum or plasma is a pentamer of identical subunits, which adds complexity to the application of higher-order CRMs and RMPs. The JCTLM convened a workshop in December 2022 to review the appropriate implementation of metrological traceability of CRP measurements. The workshop consensus was that the extent-of-equivalence data must include considerations about the impact of a new CRM when used for its intended purpose in the calibration hierarchies of existing end-user measuring systems; and that a new RMP must compare results with another existing well validated candidate RMP or with a globally available end-user measurement system.
摘要：
实验室医学可追溯性联合委员会（JCTLM）目前列出了二级可交换的认证参考材料（CRM）ERMDA-474/IFCC（DA-474）“人血清中的C反应蛋白”和两个通用的基于免疫测定的方法原则，作为通过医学实验室使用的最终用户测量程序实现C反应蛋白（CRP）测量的计量可追溯性的基础。当前的计量可追溯性已经为不同最终用户测量程序之间的临床样品产生了很好的协调结果。新的高阶纯物质和二级可交换CRM已被JCTLM提名上市。然而,支持这些新候选CRM性能的数据，包括使用新的基于质谱的候选参考测量程序（RMP），尚不清楚引入这些新CRM对现有计量可追溯性达到DA-474的当前良好协调结果的影响。血清或血浆中的临床相关CRP被测量是相同亚基的五聚体，这增加了高阶CRM和RMP应用的复杂性。JCTLM于2022年12月召开了一个研讨会，以审查CRP测量的计量可追溯性的适当实施。研讨会的共识是，等效程度数据必须考虑新CRM在现有最终用户测量系统的校准层次结构中用于预期目的时的影响；新的RMP必须将结果与另一个现有的经过良好验证的候选RMP或全球可用的最终用户测量系统进行比较。
