标题：Comparison of New Liquid Chromatography-Mass Spectrometry Method and Enzyme-Multiplied Immunoassay Technique for Routine Therapeutic Drug Monitoring of Vancomycin in Chinese Patients
作者：Yuan, Guiyan; Liu, Huanjun; Shaikh, Abdul S.; Zhang, Rui; Li, Pingli; Wang, Benjie; Guo, Ruichen
作者机构：[Yuan, Guiyan; Liu, Huanjun; Shaikh, Abdul S.; Zhang, Rui; Li, Pingli; Wang, Benjie; Guo, Ruichen] Shandong Univ, Qilu Hosp, Inst Clin Pharmacol, Wenh 更多
通讯作者地址：[Guo, RC]Shandong Univ, Qilu Hosp, Inst Clin Pharmacol, Wenhua Xi Rd 107, Jinan, Shandong, Peoples R China.
关键词：vancomycin; liquid chromatography-mass spectrometry; enzyme-multiplied; immunoassay technique; therapeutic drug monitoring; comparison
摘要：Background: Therapeutic drug monitoring of vancomycin is very valuable due to the good correlation between trough levels and clinical outcome. Therefore, it is important to accurately determine the concentration of vancomycin in patient plasma for adequate dose-adjustment. The objective of this study was to develop a new liquid chromatography-mass spectrometry (LC-MS) method for determination of vancomycin in patient plasma and compare the results with those obtained from enzyme-multiplied immunoassay technique (EMIT).; Methods: After extraction by simple protein precipitation, vancomycin and bergenin (internal standard) were separated on a C-18 column (150x4.6 mm, 5 mu m) at 40 degrees C by gradient elution with 0.1% formic acid and acetonitrile as the mobile phase and measured by electrospray ionization source in positive selective ion monitoring mode. Seventy-nine plasma samples from patients with severe infection were analyzed by enzyme-multiplied immunoassay technique and LC-MS method. MedCalc 15.2 software with Bland-Altman analysis and Passing-Bablok regression analysis was used for statistical analysis.; Results: The weighted (1/x(2)) calibration curve of the validated LC-MS was linear within the concentration range of 0.25 - 40 mu g/mL. The inter- and intra-day precisions (%RSD) were less than 10.0%. No significant matrix effect was observed in the relevant time ranges. Comparison of the two methods indicated that results of the LC-MS were close to that of EMIT with a correlation coefficient of 0.957. Upon Bland-Altman analysis, the bias amounted to 2.9 mu g/mL (95% confidence intervals of -3.4 - 9.2 mu g/mL).; Conclusions: The established LC-MS method and EMIT were both suitable for routine TDM of vancomycin.