| 引用本文: | 陈晓宇,叶冬梅,刘代华,黎涛,蒙光义,李岩.液相色谱-串联质谱法检测伏立康唑血药浓度规范化的建议[J].中国临床新医学,,():-. |
| .液相色谱-串联质谱法检测伏立康唑血药浓度规范化的建议[J].中国临床新医学,,():-. |
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| 摘要: |
| 液相色谱-串联质谱技术(LC-MS/MS)是结合液相高效分离与质谱高选择性和高灵敏度的一种分析方法,广泛应用于血药浓度监测,常用于检测血浆样本中的伏立康唑浓度。该方法虽具有高准确性、高专属性、高分辨率等优势,由于实验室内部及不同实验室之间的检测结果可能受仪器、色谱柱、试剂、校准物、方法学及其性能验证、环境和人员等多种因素的影响,存在一定程度的偏差。为规范LC-MS/MS检测伏立康唑血药浓度的操作流程,基于现有临床质谱检测相关指导文件和临床实践文献,从标准物质、内标物、样本前处理方法、色谱条件、质谱参数、方法验证、样本要求、人员管理、质量控制及参考区间等方面提出建议,制定LC-MS/MS规范化检测伏立康唑血药浓度的广西专家共识,旨在提高伏立康唑血药浓度检测结果的准确性及稳定性,保证不同人员操作、不同检测时间、不同仪器设备及不同实验室检测结果的一致性和可比性。 |
| 关键词: 伏立康唑 液相色谱-串联质谱法 血药浓度 |
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| Recommendations for Standardization of Voriconazole Blood Concentration Detection by Liquid Chromatography-Tandem Mass Spectrometry. |
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Guangxi Academy of Medical Sciences and the People’s Hospital of Guangxi Zhuang Autonomous Region
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| Abstract: |
| Liquid chromatography-tandem mass spectrometry (LC-MS/MS) is an analytical technique that combines the high separation efficiency of liquid chromatography with the high selectivity and sensitivity of mass spectrometry. It is widely used for therapeutic drug monitoring and is commonly employed to determine voriconazole concentrations in plasma samples. Although this method offers high accuracy,specificity,and resolution,there can be some degree of variability in results due to various factors,including instruments,chromatographic columns,reagents,calibrators,methodologies and performance validations,environmental conditions,and personnel,both within and between laboratories. To standardize the operation procedure of voriconazole plasma concentration detection by LC-MS/MS,based on the existing clinical mass spectrometry assay-related guidance documents and clinical practice literature,suggestions were made in terms of standard substances,internal standard selection,sample pretreatment methods,chromatographic conditions,mass spectrometry parameters,method validation,sample requirements,personnel management,quality control,and reference intervals. To establish a standardized protocol for detecting voriconazole plasma concentrations using LC-MS/MS in Guangxi,to improve the accuracy and stability of voriconazole test results. This consensus seeks to ensure consistency and comparability of results across different operators,testing times,instruments,and laboratories. |
| Key words: Voriconazole Liquid chromatography-tandem mass spectrometry Plasma drug concentration |
