解决分析挑战,以提高实验室在未结合的流西林测量的一致性
Cathérine Van Herteryck1, Tim Reyns2, Nynke Jager3
1Department of Diagnostic Sciences, Ghent University, Ghent, Belgium.
Therapeutic drug monitoring
|March 10, 2026
概括
准确量化未结合的流西林 (FLU) 对于治疗药物监测至关重要. 使用超过 (UF) 开发了一种经过验证的LC-HRMS方法,显示出良好的实验室间协议,并由于超过的不稳定性,建议用于样品存储的血矩阵.
科学领域:
- 药理学和制药科学 药理学和制药科学
- 分析化学 分析化学
- 临床化学 临床化学
背景情况:
- 在治疗药物监测 (TDM) 时,精确量化血中流西林 (FLU) 是必不可少的.
- 只有未结合的FLU在药理上是活跃的,需要超过 (UF) 等方法进行分离.
- 缺乏标准化的UF协议限制了实验室间的可重复性.
研究的目的:
- 开发和验证一个强大的液体染色学高分辨率质谱法 (LC-HRMS) 方法来量化未结合的FLU.
- 评估分析物的稳定性,并与外部实验室进行交叉验证,以协调UF协议.
主要方法:
- 在化后获得的超过和UF,通过LC-HRMS进行分析.
- 方法验证包括校准曲线,选择性,转移,准确性,精度,矩阵效应,稳定性,稀释完整性,非特异性结合和膜蛋白泄漏.
- 交叉验证使用临床常规中的患者样本进行.
主要成果:
- 成功验证方法. 成功验证方法.
- 超过的稳定性明显低于血稳定性,需要立即进行过后分析.
- 实验室间的比较显示出强烈的一致性 (>90%的样本差异<±25.0%).
结论:
- 开发了一种经过验证的LC-HRMS方法,用于使用UF量化未结合的FLU.
- 协调关键的UF参数 (设备类型,温度) 使得实验室间的结果可以比较.
- 由于超过的稳定性有限,建议将样品储存在血矩阵中.
相关概念视频
Data Validation
Method validation is a crucial process in analytical chemistry designed to confirm that a given method consistently produces reliable and high-quality results. This process is essential when a method is applied to different sample matrices or when procedural modifications are made, ensuring that the results meet acceptable standards across various applications.
Key parameters for method validation include:
Key parameters for method validation include:
Blank Solutions
A blank solution is a solution that does not contain the analyte, or the substance of interest being tested or measured. It is typically prepared using the same reagents and procedure as the sample solution but without adding the analyte. The primary purpose of preparing a blank solution is to account for any background interference or contamination that may affect the accuracy and reliability of the analytical method.
In some experimental cases, the reagents, solvents, or lab equipment used in...
In some experimental cases, the reagents, solvents, or lab equipment used in...
Contaminants and Errors
Effective sample preparation is crucial for accurate and reliable laboratory analysis. During this process, two significant sources of error can arise: concentration bias from improper sample splitting and contamination caused by methods used to reduce particle size, such as grinding or homogenization. Identifying and minimizing these potential errors is crucial to ensuring the validity of the analysis.
Another key consideration is determining the appropriate number of samples required to...
Another key consideration is determining the appropriate number of samples required to...


