运用 ISO/TS 20914:2019 计算临床实验室中免疫抑制药物的测量不确定度。

Using ISO/TS 20914:2019 to calculate the measurement uncertainty of immunosuppressive drugs in a clinical laboratory.

机构信息

Institute of Clinical Chemistry, Hannover Medical School, Hannover, Germany.

出版信息

Scand J Clin Lab Invest. 2020 Jul;80(4):309-312. doi: 10.1080/00365513.2020.1731849. Epub 2020 Mar 2.

DOI:10.1080/00365513.2020.1731849

Abstract

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 > 2000 measurements each of four control levels within one year. Lower uncertainties were observed if the material was native pooled blood (13% to 17%, > 300 measurements, one year).

摘要

根据标准 ISO 15189，临床常规实验室应估计其提供的测量物的患者结果的测量不确定度（MU）。到目前为止，还没有被接受的关于如何执行的描述。最近，ISO 技术标准 ISO/TS 20914 发布，为不确定性估计提供了实用指南。免疫抑制剂 Everolimus、Ciclosporin、Sirolimus 和 Tacrolimus 的治疗窗较窄。因此，应该考虑它们的 MU 来做出临床决策。这里，详细介绍了如何使用通过 LC-MS/MS 技术广泛认证的 CE 测定法来估计测量免疫抑制剂的 MU 的方法。即，根据 2000 多次测量结果，每种分析物的 MU 在 13%至 27%之间，浓度也会影响 MU。如果物质是原始混合血液（13%至 17%，300 多次测量，一年），则会观察到较低的不确定性。