Jeon Yongbum, Han Minje, Han Eun Young, Lee Kyunghoon, Song Junghan, Song Sang Hoon
Department of Laboratory Medicine, Seoul National University Hospital, 101 Daehak-ro, Jongno-gu, Seoul 03080, Korea.
Department of Laboratory Medicine, Sheikh Khalifa Specialty Hospital, Ras Al Khaimah, United Arab Emirates.
Pract Lab Med. 2017 May 13;8:86-94. doi: 10.1016/j.plabm.2017.05.002. eCollection 2017 Aug.
Voriconazole is a triazole antifungal developed for the treatment of fungal infectious disease, and the clinical utility of its therapeutic drug monitoring has been evaluated. Recently, a new assay for analyzing the serum voriconazole concentration with an automated clinical chemistry analyzer was developed. We evaluated the performance of the new assay based on standardized protocols.
The analytical performance of the assay was evaluated according to its precision, trueness by recovery, limit of quantitation, linearity, and correlation with results from liquid chromatography-tandem mass spectrometry (LC-MS/MS). The evaluation was performed with the same protocol on two different routine chemistry analyzers. All evaluations were performed according to CLSI Guidelines EP15, EP17, EP6, and EP9 [1-4].
Coefficients of variation for within-run and between-day imprecision were 3.2-5.1% and 1.5-3.0%, respectively, on the two different analyzers for pooled serum samples. The recovery rates were in the range of 95.4-102.2%. The limit of blank was 0.0049 μg/mL, and the limit of detection of the samples was 0.0266-0.0376 μg/mL. The percent recovery at three LoQ levels were 67.9-74.6% for 0.50 μg/mL, 75.5-80.2% for 0.60 μg/mL, and 89.9-96.6% for 0.70 μg/mL. A linear relationship was demonstrated between 0.5 μg/mL and 16.0 μg/mL ( =0.9995-0.9998). The assay correlated well with LC-MS/MS results ( =0.9739-0.9828).
The assay showed acceptable precision, trueness, linearity, and limit of quantification, and correlated well with LC-MS/MS. Therefore, its analytical performance is satisfactory for monitoring the drug concentration of voriconazole.
伏立康唑是一种开发用于治疗真菌感染性疾病的三唑类抗真菌药物，其治疗药物监测的临床实用性已得到评估。最近，开发了一种使用自动临床化学分析仪分析血清伏立康唑浓度的新方法。我们根据标准化方案评估了该新方法的性能。
根据该方法的精密度、回收率真实性、定量限、线性以及与液相色谱 - 串联质谱法（LC-MS/MS）结果的相关性来评估其分析性能。在两台不同的常规化学分析仪上按照相同方案进行评估。所有评估均根据CLSI指南EP15、EP17、EP6和EP9 [1 - 4]进行。
对于混合血清样本，在两台不同分析仪上，批内不精密度和批间不精密度的变异系数分别为3.2 - 5.1%和1.5 - 3.0%。回收率在95.4 - 102.2%范围内。空白限为0.0049μg/mL，样本检测限为0.0266 - 0.0376μg/mL。在三个定量限水平下，0.50μg/mL的回收率为67.9 - 74.6%，0.60μg/mL为75.5 - 80.2%，0.70μg/mL为89.9 - 96.6%。在0.5μg/mL至16.0μg/mL之间呈现线性关系（r = 0.9995 - 0.9998）。该方法与LC-MS/MS结果相关性良好（r = 0.9739 - 0.9828）。
该方法显示出可接受的精密度、真实性、线性和定量限，并且与LC-MS/MS相关性良好。因此，其分析性能对于监测伏立康唑的药物浓度是令人满意的。
