Clin Chem Lab Med. 2015 May;53(6):905-12. doi: 10.1515/cclm-2014-1240.
The measurement uncertainty budget should combine the uncertainty of higher order references, the uncertainty of commercial system calibration, the system imprecision and individual laboratory performance in terms of variability. Here we recommend that no more than one third of the total uncertainty budget, established by appropriate analytical performance specifications, is consumed by the uncertainty of references and approximately 50% of the total budget consumed by the manufacturer's calibration and value transfer protocol. The remaining 50% should be available for the commercial system imprecision (including the batch to batch variation of the reagents) and individual laboratory performance in order to fulfil the uncertainty goal. For commercial systems to work properly, in vitro diagnostics (IVD) manufacturers will need to take more responsibility and ensure the traceability of the combination of platform, reagents, calibrators and control materials for system alignment verification that only as such (as a whole) are certified ("CE marked") by the manufacturer itself in terms of traceability to the selected reference measurement system. Particularly, IVD manufacturers should report the combined (expanded) uncertainty associated with their calibrators when used in conjunction with other components of their analytical system (platform and reagents). This is more than what they are currently providing as traceability and uncertainty information.
不确定度预算应综合考虑高阶参考物质的不确定度、商业系统校准的不确定度、系统不精密度以及个体实验室在可变性方面的性能。在此，我们建议不超过总不确定度预算的三分之一由参考物质的不确定度组成，制造商的校准和赋值转移方案大约消耗总预算的 50%。其余的 50%应可用于商业系统不精密度（包括试剂批间变异）和个体实验室性能，以满足不确定度目标。为了使商业系统正常运行，体外诊断（IVD）制造商需要承担更多的责任，并确保平台、试剂、校准品和控制品组合的可追溯性，以便仅通过制造商自身对选定参考测量系统的溯源性对系统调整验证进行认证（“CE 标记”）。特别是，IVD 制造商在将其校准品与分析系统的其他组件（平台和试剂）一起使用时，应报告与其相关的组合（扩展）不确定度。这比他们目前提供的溯源性和不确定度信息要多。
