Deprez Liesbet, Johansen Jesper V, Keller Thomas, Budd Jeffrey, Greenberg Neil, Weykamp Cas, Sandberg Sverre, Panteghini Mauro, Ceriotti Ferruccio, Barczak Elizabeth, Rej Robert, Fauskanger Pernille Kjeilen, MacKenzie Finlay, Camara Johanna E, Lyle Alicia N, Miller W Greg, Delatour Vincent
European Commission, Joint Research Centre (JRC), Geel, Belgium.
Radiometer Medical ApS, Copenhagen, Denmark.
Clin Chim Acta. 2025 Feb 1;567:120097. doi: 10.1016/j.cca.2024.120097. Epub 2024 Dec 16.
Commutable secondary certified reference materials (CRMs) play an essential role in the calibration hierarchy of many in-vitro diagnostic measurement procedures used in the medical laboratory. Therefore, sustainable availability of these CRMs is crucial to guarantee the long-term equivalence of results obtained for the clinical samples. The IFCC Working Group on Commutability in Metrological Traceability (WG-CMT) has published several recommendations for assessing the commutability of secondary calibrator CRMs. Performing a full commutability study according to these recommendations may present significant demands on the resources of CRM producers. This report provides recommendations for performing commutability equivalence assessments between existing CRMs of proven commutability and replacement batches of those CRMs. The approach evaluates the relationship of measurement results obtained with the relevant measurement procedures for the replacement batch versus the existing CRM batch. If this relationship is the same, the commutability properties of the replacement batch are considered equivalent to those of the existing CRM batch. Since the existing batch has a suitable commutability, the commutability of the replacement batch is also declared fit for purpose. Because this commutability equivalence assessment involves certain risks, a small number of representative clinical samples are included as safeguards. There are several prerequisites for performing the commutability equivalence assessment and producers of secondary CRMs will probably need to implement improvements before using this approach. However, once the improvements are implemented, the commutability equivalence assessment approach will significantly reduce the resources needed to maintain the supply of CRMs.
可互换的二级标准物质（CRM）在医学实验室中许多体外诊断测量程序的校准体系中起着至关重要的作用。因此，这些CRM的可持续供应对于确保临床样本检测结果的长期等效性至关重要。国际临床化学与检验医学联合会（IFCC）计量溯源互换性工作组（WG-CMT）已发布了多项评估二级校准物CRM互换性的建议。按照这些建议进行全面的互换性研究可能会对CRM生产商的资源提出重大要求。本报告提供了在已证明具有互换性的现有CRM与这些CRM的替换批次之间进行互换性等效性评估的建议。该方法评估了使用相关测量程序对替换批次与现有CRM批次获得的测量结果之间的关系。如果这种关系相同，则认为替换批次的互换性特性与现有CRM批次的互换性特性等效。由于现有批次具有合适的互换性，因此替换批次的互换性也被声明适用于预期用途。由于这种互换性等效性评估存在一定风险，因此纳入了少量具有代表性的临床样本作为保障措施。进行互换性等效性评估有几个先决条件，二级CRM生产商在使用这种方法之前可能需要进行改进。然而，一旦实施了改进措施，互换性等效性评估方法将显著减少维持CRM供应所需的资源。
