Department of Pathology, Virginia Commonwealth University, Richmond, VA, USA.
Myers Consulting, Smyrna, GA, USA.
Clin Chem Lab Med. 2022 Oct 17;61(1):48-54. doi: 10.1515/cclm-2022-0943. Print 2023 Jan 27.
Standardized results for laboratory tests are particularly important when their interpretation depends on fixed medical practice guidelines or common reference intervals. The medical laboratory community has developed a roadmap for an infrastructure to achieve standardized test results described in the International Organization for Standardization standard 17511:2020 . Among the challenges to implementing metrological traceability are the availability of fit-for-purpose matrix-based certified reference materials (CRMs) and requirements for regulatory review that differ among countries. A workshop in December 2021 focused on these two challenges and developed recommendations for improved practices.
The participants agreed that prioritization of measurands for standardization should be based on their impact on medical decisions in a clinical pathway. Ensuring that matrix-based CRMs are globally available for more measurands will enable fit-for-purpose calibration hierarchies for more laboratory tests. Regulation of laboratory tests is important to ensure safety and effectiveness for the populations served. Because regulations are country or region specific, manufacturers must submit recalibration changes intended to standardize results for regulatory review to all areas in which a measuring system is marketed.
A standardization initiative requires collaboration and planning among all interested stakeholders. Global collaboration should be further developed for prioritization of measurands for standardization, and for coordinating the production and supply of CRMs worldwide. More uniform regulatory submission requirements are desirable when recalibration is implemented to achieve internationally standardized results.
当实验室检测结果的解释依赖于固定的医疗实践指南或常见的参考区间时，标准化的检测结果尤为重要。医学检验界已经制定了实现国际标准化组织标准 17511:2020 中描述的标准化检测结果的基础设施路线图。实现计量溯源性的挑战之一是是否有适合用途的基质基认证参考物质 (CRM)，以及各国对监管审查的要求不同。2021 年 12 月的一次研讨会重点讨论了这两个挑战，并为改进实践提出了建议。
与会者一致认为，标准化测量指标的优先级应基于其对临床路径中医疗决策的影响。确保更多测量指标的基质基 CRM 在全球范围内可用，将为更多实验室检测提供适合用途的校准层次结构。对实验室检测进行监管对于服务人群的安全性和有效性非常重要。由于法规是特定于国家或地区的，因此制造商必须向所有销售测量系统的地区提交旨在标准化检测结果的重新校准变更，以进行监管审查。
标准化倡议需要所有利益相关者之间的协作和规划。应进一步加强全球合作，以确定标准化的测量指标优先级，并协调全球范围内 CRM 的生产和供应。当实施重新校准以实现国际标准化结果时，应制定更统一的监管提交要求。
