According to the standard ISO 15189 clinical routine laboratories shall estimate measurement uncertainty (MU) of patient results of their provided measurands. Up to now there was no accepted description on how to perform. Recently, the ISO technical standard ISO/TS 20914 was published giving a practical guide for uncertainty estimation. The immunosuppressive drugs Everolimus, Ciclosporin, Sirolimus and Tacrolimus have narrow therapeutic windows. Hence, their MU should be considered for deducing clinical decisions. Here, a pathway is presented in detail on how to estimate MU measuring immunosuppressants using a widespread CE certified assay via LC-MS/MS technology. Namely, the expanded measurement uncertainties are from 13% to 27% depending on analyte and concentration. The calculation based on n > 2000 measurements each of four control levels within one year. Lower uncertainties were observed if the material was native pooled blood (13% to 17%, n > 300 measurements, one year).

根据ISO 15189标准，临床常规实验室应估计其提供的被测量者的患者结果的测量不确定度（MU）。到目前为止，还没有关于如何执行的描述。最近，ISO技术标准ISO / TS 20914出版，为不确定性评估提供了实用指南。免疫抑制药物依维莫司，环孢菌素，西罗莫司和他克莫司的治疗窗口狭窄。因此，应考虑使用其MU来推断临床决策。在此，详细介绍了如何通过LC-MS / MS技术使用广泛的CE认证测定法估算MU测量免疫抑制剂的途径。即，取决于分析物和浓度，扩展的测量不确定度从13％到27％。基于n的计算 一年内四个控制级别中的每个级别均进行了> 2000次测量。如果该材料是天然汇集血液，则不确定性较低（13％至17％，n  > 300次测量，一年）。