Department of Pathology and Laboratory Medicine, University of Texas Medical School in Houston and Laboratory Services, Houston, TX, USA.
Ther Drug Monit. 2011 Apr;33(2):149-54. doi: 10.1097/FTD.0b013e31820afc97.
Everolimus is an immunosuppressant requiring routine monitoring in whole blood. We evaluated the analytical performance of a new immunoassay for everolimus, Quantitative Microsphere System (QMS) everolimus (Thermo Fisher Scientific), which is CE marked and currently under review by Food and Drug Administration of the United States by comparing results with values obtained by using liquid chromatography/mass spectrometry. The total coefficient of variations (CVs) were 8.3% for low control (mean: 3.8 ng/mL), 6.1% for the medium control (mean: 8.0 ng/mL), and 7.5% for the high control (mean: 14.4 ng/mL) (n = 80 for each control, run over 20 nonconsecutive days). The respective total CVs for patients' pool were 13.3% (mean: 4.0 ng/mL), 7.5% (mean: 8.2 ng/mL), and 8.7% (mean: 11.7 ng/mL) (n = 80 for each patient pool). The assay was linear from a whole-blood everolimus level between 1.5 and 20 ng/mL, and the limit of quantitation was 1.3 ng/mL. Comparison was carried out using 90 renal transplant patient samples, and we observed the following Passing and Bablok linear regression plot: y = 1.11, slope = -0.005 (R = 0.92). This assay was not affected by commonly used 70 drugs, but sirolimus, a drug structurally similar to everolimus, showed 46% cross-reactivity. We conclude that QMS everolimus immunoassay has adequate sensitivity and specificity for the determination of whole-blood everolimus and can be used for routine therapeutic drug monitoring.
依维莫司是一种免疫抑制剂，需要在全血中进行常规监测。我们通过比较与使用液相色谱/质谱法获得的值的结果，评估了新的依维莫司免疫分析物（定量微球系统（QMS）依维莫司（赛默飞世尔科技））的分析性能，该分析物已获得 CE 标志，并正在接受美国食品和药物管理局的审查。低对照品（平均值：3.8ng/ml）的总变异系数（CV）为 8.3%，中对照品（平均值：8.0ng/ml）的总 CV 为 6.1%，高对照品（平均值：14.4ng/ml）的总 CV 为 7.5%（n=80，每个对照品连续 20 天运行）。患者组的总 CV 分别为 13.3%（平均值：4.0ng/ml）、7.5%（平均值：8.2ng/ml）和 8.7%（平均值：11.7ng/ml）（n=80 个患者组）。该检测方法在全血依维莫司水平为 1.5 至 20ng/ml 之间呈线性，定量限为 1.3ng/ml。使用 90 个肾移植患者样本进行了比较，我们观察到以下通过和巴布洛克线性回归图：y=1.11，斜率=-0.005（R=0.92）。该检测方法不受常用的 70 种药物的影响，但结构上与依维莫司相似的西罗莫司的交叉反应性为 46%。我们得出结论，QMS 依维莫司免疫分析法具有足够的灵敏度和特异性，可用于全血依维莫司的测定，并可用于常规治疗药物监测。
