在外部质量评估方案中测量万科米的实验室间变异性 2016-2025年
Anders Larsson1, Jonathan Cedernaes1, Mats B Eriksson2
1Department of Medical Sciences, Clinical Chemistry and Pharmacology, Uppsala University, Uppsala, Sweden.
Clinical biochemistry
|February 8, 2026
概括
范科米辛免疫检测结果在制造商之间有很大的差异,这影响了准确的治疗药物监测. 协调校准对于一致的患者护理和避免万科米辛毒性至关重要.
科学领域:
- 临床化学 临床化学
- 药理学 药理学是指药理学的学科.
- 分析科学 分析科学
背景情况:
- 范科米辛对于严重的格拉姆阳性感染至关重要.
- 精确的万科米辛血水平是必不可少的,因为其狭窄的治疗指数.
- 免疫试验的跨平台变异性可能会阻碍可靠的治疗药物监测.
研究的目的:
- 评估万科米辛免疫试验中的方法间偏差和时间趋势.
- 评估跨不同免疫测试平台的万科米辛结果的可比性.
- 突出需要在治疗药物监测中改进校准协调.
主要方法:
- 对78个外部质量保证样本 (2016-2025) 的分析.
- 包括来自七个主要免疫测试制造商的7104个测试结果.
- 将制造商的结果与平均共识值进行比较.
主要成果:
- 在Abbott,Thermo Fisher,Ortho和西门子测试中观察到显著的系统偏差.
- 贝克曼·科尔特和西门子显示了显著的时间漂移.
- 各种方法的变化系数从0.9%到12.1%不等.
结论:
- 通常使用的万科米辛免疫测试显示出相当大的方法间偏差和时间漂移.
- 需要改进校准协调和可追溯性.
- 一致的万科米辛治疗药物监测需要标准化的测定性能.
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