Development and validation of an enzyme-linked immunosorbent assay for the quantification of gelonin in mouse plasma.
Development and validation of an enzyme-linked immunosorbent assay for the quantification of gelonin in mouse plasma.
复制标题
DOI：
10.1080/15321819.2016.1182551
复制
发表时间：
2016-01-01
影响因子：
--
通讯作者：
Balthasar, Joseph P
中科院分区：
文献类型：
--
作者：
Engler, Frank A;Balthasar, Joseph P
本文详细介绍了一种酶联免疫吸附测定（ELISA）的定量小鼠血浆中白树素的开发和验证。在7.5-100 ng/mL的标准曲线范围内验证了ELISA的日内和日间变异性和准确度。然后应用该测定来评估白树素在小鼠中的药代动力学。将ELISA的结果与用（125）碘标记的白树毒素进行的平行研究中获得的数据进行比较，并通过γ计数进行定量。ELISA法具有良好的精密度，日内和日间质控样品的变异系数分别为5.4-9.3%和2.9- 7.3%。样品回收率范围为标称值的98.3-105%。ELISA方法产生较低的血浆浓度的白树毒素比发现从较低的具体γ计数方法。因此，药代动力学分析得出的分布容积（106 ± 31 vs. 55.8 ± 13 mL/kg）和血浆清除率（34.7 ± 6.6 vs. 10.9 ± 2.1 mL/min/kg）的估计值显著高于ELISA法测定的数据。
This article details the development and validation of an enzyme-linked immunosorbent assay (ELISA) for the quantification of gelonin in mouse plasma. The ELISA was validated for intra- and inter-day variability and for accuracy over a standard curve range of 7.5-100 ng/mL. The assay was then applied to assess gelonin pharmacokinetics in mice. Results from the ELISA were compared to data obtained from a parallel study conducted with (125)Iodine-labeled gelonin, with quantification via gamma counting. The ELISA demonstrated good precision, as the percent coefficient of variation of quality control samples in intra-day and inter-day validation ranged from 5.4-9.3% and 2.9-7.3%, respectively. Sample recoveries ranged from 98.3-105% of nominal values. The ELISA method yielded lower plasma concentrations of gelonin than found from the less-specific gamma counting method. Consequently, pharmacokinetic analyses yielded significantly higher estimates for volume of distribution (106 ± 31 vs. 55.8 ± 13 mL/kg) and plasma clearance (34.7 ± 6.6 vs. 10.9 ± 2.1 mL/min/kg) for data determined by ELISA vs. by gamma counting.