Research Centre for Metrological Traceability in Laboratory Medicine (CIRME), Università di Milano, Milan, Italy.
UOC Patologia Clinica, ASST Fatebenefratelli-Sacco, Via GB Grassi 74, 20157 Milan, Italy.
Clin Chem Lab Med. 2020 Jul 28;58(8):1200-1204. doi: 10.1515/cclm-2019-1128.
Background The Joint Committee on Traceability in Laboratory Medicine (JCTLM) has recently created the Task Force on Reference Measurement System Implementation (TF-RMSI) for providing guidance on traceability implementation to in vitro diagnostics (IVD) manufacturers. Using serum creatinine (sCr) as an example, a preliminary exercise was carried out by checking what type of information is available in the JCTLM database and comparing this against derived analytical performance specifications (APS) for measurement uncertainty (MU) of sCr. Content APS for standard MU of sCr measurements were established as a fraction (≤0.75, minimum quality; ≤0.50, desirable quality; and ≤0.25, optimum quality) of the intra-individual biological variation of the measurand (4.4%). By allowing no more than one third of the total MU budget for patient samples to be derived from higher-order references, two out of the four JCTLM reference materials (RMs) at least allow minimum APS to be achieved for the MU of patient samples. Commutability was explicitly assessed for one of the JCTLM-listed matrixed RMs, which was produced in compliance with ISO 15194:2009 standard, whereas the remaining three RMs were assessed against the ISO 15194:2002 version of the standard, which only required the extent of commutability testing to be reported. Regarding the three listed reference methods, the MU associated with isotopic dilution-mass spectrometry coupled to gas chromatography (ID/GC/MS) and isotopic dilution-mass spectrometry coupled to liquid chromatography (ID/LC/MS) would allow APS to be fulfilled, while the isotope dilution surface-enhanced Raman scattering (ID/SERS) method displays higher MU. Summary The most recently listed RM for sCr in the JCTLM database meets the ISO 15194:2009 requirements with MU that would allow APS to be fulfilled and has had commutability demonstrated for use as a common calibrator in implementing traceability of sCr measurements. Splitting clinical samples with a laboratory performing ID/GC/MS or ID/LC/MS provides an alternative but would also require all components of uncertainty of these materials to be assessed. Outlook Using appropriately derived APS to judge whether reference measurement system components are fit for purpose represents a novel approach. The TF-RMSI is planning to review a greater number of measurands to provide more robust information about the state of the art of available reference measurement systems and their impact on the ability of clinical measurements to meet APS.
背景 实验室医学溯源联合委员会（JCTLM）最近成立了参考测量系统实施工作队（TF-RMSI），为体外诊断（IVD）制造商提供溯源实施指南。以血清肌酐（sCr）为例，通过检查 JCTLM 数据库中可用的信息类型，并将其与 sCr 测量不确定度（MU）的衍生分析性能规格（APS）进行比较，进行了初步的研究。 作为被测量个体内生物学变异的分数（≤0.75，最低质量；≤0.50，理想质量；≤0.25，最佳质量），建立了 sCr 标准 MU 的 APS。通过允许患者样本的 MU 预算中不超过三分之一来自更高阶参考，至少有两种 JCTLM 参考物质（RMs）允许达到患者样本 MU 的最低 APS。其中一种 JCTLM 列出的基质 RM 明确评估了可互换性，该 RM 是根据 ISO 15194:2009 标准生产的，而其余三种 RM 则根据 ISO 15194:2002 版本的标准进行评估，该标准仅要求报告可互换性测试的程度。 关于三种列出的参考方法，与气相色谱（ID/GC/MS）和液相色谱（ID/LC/MS）偶联的同位素稀释质谱法（ID/GC/MS）和与液相色谱（ID/LC/MS）偶联的同位素稀释质谱法（ID/LC/MS）相关联的 MU 允许满足 APS，而同位素稀释表面增强拉曼散射（ID/SERS）方法显示出更高的 MU。 总结 JCTLM 数据库中最新列出的 sCr RM 符合 ISO 15194:2009 要求，具有允许满足 APS 的 MU，并已证明可互换性，可作为实施 sCr 测量溯源的通用校准器。 对于进行 ID/GC/MS 或 ID/LC/MS 的实验室，将临床样本分开提供了一种替代方法，但也需要评估这些材料不确定性的所有组成部分。 展望 使用适当推导的 APS 来判断参考测量系统组件是否适合用途代表了一种新方法。TF-RMSI 计划审查更多的被测量物，以提供有关可用参考测量系统的最新状态及其对临床测量满足 APS 的能力的影响的更可靠信息。
