用免疫测定法测定伏立康唑的稳定性和分析特性

IF 1.8 Q3 MEDICAL LABORATORY TECHNOLOGY
Veni Bharti, Benjamin Jung, Sarah Lam, Ansel Fabros, Rajeevan Selvaratnam
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引用次数: 0

摘要

背景:伏立康唑是一种广谱三唑类抗真菌药物,建议用于治疗侵袭性真菌病,包括侵袭性曲霉菌病。通过伏立康唑目标谷浓度进行治疗药物监测对于确保疗效同时预防毒性非常重要。我们的目的是通过免疫测定法确定伏立康唑的稳定性:采用液相色谱-串联质谱(LC-MS/MS)方法对患者样本(n = 45)中的血浆进行评估,并与雅培 Alinity c 分析仪上经过调整和优化的 ARK 免疫测定方法进行比较。评估了伏立康唑的稳定性和 ARK 免疫分析法的分析性能,包括功能灵敏度、空白限 (LoB)、检出限 (LoD) 和定量限 (LoQ)、线性度和精密度:ARK 伏立康唑免疫测定与 LC-MS/MS 方法高度相关(Pearson R = 0.988),平均偏差为 0.09 mg/L(2%)。当 LoQ 为 0.5 mg/L 时,CV 为 3.7%,而功能灵敏度为 0.05 mg/L。从 ARK 获得的液体质控材料在 1 mg/L、5 mg/L 和 10 mg/L 时的总体不精确度分别为 5.0%、6.3% 和 5.9%。空白限和 LoD 分别为 0.02 mg/L 和 0.05 mg/L。肝素锂血浆分离管中的伏立康唑会随着时间的推移而下降,在接近或高于毒性浓度时下降更为明显:结论:在凝胶分离管中收集的伏立康唑会随着时间的推移而下降,这可能是由于吸收特性造成的。免疫测定法和 LC-MS/MS 法测定的伏立康唑具有可接受的可比性、足够的灵敏度和精确度。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Stability and Analytical Characterization of Voriconazole as Measured by Immunoassay.

Background: Voriconazole is a broad-spectrum triazole antifungal agent recommended for invasive fungal diseases, including invasive aspergillosis. Therapeutic drug monitoring via voriconazole target trough concentration is important to ensure efficacy while preventing toxicity. Our aim was to determine the stability of voriconazole as adapted and measured by an immunoassay.

Methods: Plasma from patient samples (n = 45) evaluated by a liquid chromatography with tandem mass spectrometry (LC-MS/MS) method was compared against an ARK immunoassay method, adapted and optimized on the Abbott Alinity c analyzer. Stability of voriconazole and analytical performance of ARK immunoassay was assessed, including functional sensitivity, limit of blank (LoB), limit of detection (LoD), and limit of quantification (LoQ), linearity, and precision.

Results: ARK voriconazole immunoassay was highly correlated (Pearson R = 0.988) to the LC-MS/MS method, with an average bias of 0.09 mg/L (2%). CV at LoQ of 0.5 mg/L was 3.7% while the functional sensitivity was established at 0.05 mg/L. Overall imprecision with liquid quality control material obtained from ARK was 5.0%, 6.3%, and 5.9% at 1 mg/L, 5 mg/L, and 10 mg/L, respectively. Limit of blank and LoD were 0.02 mg/L and 0.05 mg/L, respectively. Voriconazole in lithium heparin plasma separator tube declines over time, with a decrease that is more evident near or above toxic concentrations.

Conclusion: Voriconazole collected in gel separation tubes declines over time, possibly due to absorptive properties. Voriconazole measurements by immunoassay and LC-MS/MS demonstrated acceptable comparability with sufficient level of sensitivity and precision.

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来源期刊
Journal of Applied Laboratory Medicine
Journal of Applied Laboratory Medicine MEDICAL LABORATORY TECHNOLOGY-
CiteScore
3.70
自引率
5.00%
发文量
137
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