在临床实验室使用平衡透析估计自由药物度的测量不确定性
Raúl Rigo-Bonnin1, Virgínia Mas-Bosch1, Francesca Canalias2
1Laboratori Clínic, IDIBELL, Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat, Barcelona, Spain.
Clinical chemistry and laboratory medicine
|December 5, 2023
概括
本研究提出了一种方法,用于估计使用平衡透析 (ED) 的自由药物度测量中的测量不确定性 (MU). 准确的MU估计对于可靠的治疗药物监测 (TDM) 至关重要.
科学领域:
- 临床化学 临床化学
- 分析化学 分析化学
- 药理动力学 药理动力学
背景情况:
- 平衡透析 (ED) 用于测量自由药物度,以改善治疗药物监测 (TDM).
- ED程序需要特定的样本准备,容易陷入陷,影响结果的准确性.
- 准确的测量结果对于正确的临床解释至关重要,测量不确定性 (MU) 是ISO 15189.9规定的准确度关键指标.
研究的目的:
- 提出一种方法来估计在使用平衡透析 (ED) 时血清中自由药物度的测量不确定性 (MU).
- 为临床实验室提供一个框架来实施MU研究以进行免费的药物度分析.
主要方法:
- 采用了综合的自上而下的和自下而上的方法来估计MU,遵守ISO/TS 20914:2019和JCGM 100:2008指南.
- 作为一个案例研究,利用了血清中的自由氨酸度.
- 纳入的场景考虑了ED固有的非特异性结合,体积转移和吉布斯-多南效应的潜在偏差.
主要成果:
- 估计扩展不确定性在13.0%至30.9%之间.
- 当体积转移和吉布斯-多南效应存在显著偏差时,观察到最高的MU值.
- 证明ED特异性的缺点对自由药物度测量的整体不确定性的影响.
结论:
- 使用ED测量自由药物度时估计MU的详细方法,考虑各种影响因素.
- 该研究鼓励临床实验室对自由药物度进行MU评估.
- 实施MU研究可以提高治疗药物监测的可靠性和临床效用.
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