自动LC-MS/MS:准备好临床常规实验室工作吗?
Sina Junger1, Miriam Hoene2, Maria Shipkova1
1SYNLAB MVZ Leinfelden-Echterdingen GmbH, Leinfelden-Echterdingen, Germany.
Journal of mass spectrometry and advances in the clinical lab
|August 16, 2023
概括
一个完全自动化的液体染色学-并联质谱学 (LC-MS/MS) 系统证明了维生素D和免疫抑制药物测试的高精度和准确性. 这种自动化LC-MS/MS适用于商业实验室的常规诊断.
科学领域:
- 临床化学 临床化学
- 分析化学 分析化学
- 质谱测量质量谱测量
背景情况:
- 液体染色学-并联质谱学 (LC-MS/MS) 为临床诊断提供了高灵敏度和特异性.
- 常规临床实验室使用LC-MS/MS受到复杂性和缺乏自动化的限制.
- 之前的研究表明,在医院环境中,自动化LC-MS/MS的性能很好.
研究的目的:
- 评估完全自动化的LC-MS/MS系统在商业实验室环境中的适用性.
- 评估各种实验室操作员对自动化LC-MS/MS系统的可用性.
- 将自动化系统的性能与商业实验室现有的方法进行比较.
主要方法:
- 自动LC-MS/MS的分析性能在5个月内对25-氧维生素D和免疫抑制药物 (ISD) 进行了评估.
- 测试结果与医院实验室的相同分析仪,内部LC-MS/MS方法和化学发光微粒免疫测试 (CMIA) 相比较.
- 九个运营商通过结构化问卷评估了系统的可用性.
主要成果:
- 自动化系统表现出高精度 (CV<8%) 和准确性 (偏差<7%),与外部质量评估样本保持良好一致.
- 结果与医院实验室中相同的分析仪相当.
- 与内部LC-MS/MS方法相比,对25-OH维生素D3,环素A和塔克罗利斯观察到可接受的中位偏差;25-OH维生素D3与免疫试验的偏差是可以接受的.
- 所有运营商都报告了积极的用户体验.
结论:
- 一个完全自动化的LC-MS/MS系统非常适合在商业实验室中整合到常规诊断中.
- 该系统的可用性和分析性能支持其在各种实验室环境中采用.
- 自动化解决了复杂性,并提高了LC-MS/MS在临床诊断中的常规应用.
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