在血液中测量埃弗罗利斯的3种不同方法之间缺乏可互换性:ACMIA,LTIA和UHPLC-MS/MS
Chika Miyagi1, Ryota Tanaka, Ken Shiraiwa
1Department of Clinical Pharmacy, Oita University Hospital, Yufu, Oita, Japan.
Therapeutic drug monitoring
|July 31, 2024
概括
亲和介导免疫试验 (ACMIA) 和乳聚流体测量免疫试验 (LTIA) 不能与UHPLC-MS/MS进行互换,用于常的监测. 由于显著的比例偏差,建议在切换量化方法时谨慎使用.
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.
- 分析化学 分析化学
背景情况:
- 亲和介导免疫测试 (ACMIA) 提供了诸如没有预处理和广泛校准范围等优势.
- 没有先前的研究直接将ACMIA与乳聚合度测定免疫试验 (LTIA) 进行比较.
- 评估试验可互换性对于可靠的治疗药物监测至关重要.
研究的目的:
- 评估ACMIA和LTIA与超高性能液体染色学结合联质谱学 (UHPLC-MS/MS) 的可互换性.
- 为了比较ACMIA和LTIA在Everolimus量化方面的分析性能.
主要方法:
- 分析了111个全血样本,这些样本来自接受everolimus治疗的患者.
- 利用强大的Passing-Bablok回归和Bland-Altman图表来评估方法的一致性.
- 在UHPLC-MS/MS的使用中,Everolimus的量化使用了参考方法.
主要成果:
- UHPLC-MS/MS量化了所有样本;LTIA和ACMIA分别有56个和1个样本低于量化限度.
- 在所有三种方法 (ACMIA与UHPLC-MS/MS,LTIA与UHPLC-MS/MS,ACMIA与LTIA) 之间发现了显著的比例偏差.
- 布兰德-阿尔特曼分析证实了统计学上显著的偏差,表明缺乏可互换性.
结论:
- 显著的比例偏差排除了ACMIA,LTIA和UHPLC-MS/MS之间的可互换性.
- 在改变量化试验时,对Everolimus度的临床解释需要谨慎.
- 准确的治疗药物监测需要标准化或仔细的方法验证.
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