Liang Junyu, Zhang Zhigao, Zhao Hui, Wan Shanhe, Zhai Xiangming, Zhou Jianwei, Liang Rongliang, Deng Qiaoting, Wu Yingsong, Lin Guanfeng
Institute of Antibody Engineering, School of Laboratory Medicine and Biotechnology, Southern Medical University Guangzhou China
Department of Plastic and Aesthetic Surgery, Third Affiliated Hospital, Sun Yat-Sen University Guangzhou China.
RSC Adv. 2018 Apr 25;8(28):15621-15631. doi: 10.1039/c8ra01807c. eCollection 2018 Apr 23.
Developing a simple analytical method suitable for therapeutic drug monitoring in a clinical setting is key to establishing guidelines on accurate dose administration and the advancement of precision medicine. We devised a simple rapid analytical method through the combination of streptavidin-modified microparticles and a time-resolved fluorescence immunoassay for therapeutic drug monitoring. The analytical performance of this method was investigated and validated using clinical samples. By determination of doxorubicin concentration, the proposed assay has shown a satisfactory linear range of detection (3.8-3000 ng mL) with a limit of detection of 3.8 ng mL and an IC of 903.9 ng mL. The intra and inter-assay coefficients of variation were 4.12-5.72% and 5.48-6.91%, respectively, and the recovery was acceptable. The applicability of the proposed assay was assessed by comparing the determined results with those measured by LC-MS/MS, presenting a satisfactory correlation ( = 0.9868). The proposed assay, which shows satisfactory analytical performance, has great potential for application in the field of TDM in the future.
开发一种适用于临床环境中治疗药物监测的简单分析方法是建立准确剂量给药指南和推进精准医学的关键。我们通过将链霉亲和素修饰的微粒与时间分辨荧光免疫分析相结合,设计了一种简单快速的分析方法用于治疗药物监测。使用临床样本对该方法的分析性能进行了研究和验证。通过测定阿霉素浓度,所提出的检测方法显示出令人满意的线性检测范围(3.8 - 3000 ng/mL),检测限为3.8 ng/mL,IC为903.9 ng/mL。批内和批间变异系数分别为4.12 - 5.72%和5.48 - 6.91%,回收率可接受。通过将测定结果与LC-MS/MS测量结果进行比较,评估了所提出检测方法的适用性,呈现出令人满意的相关性(r = 0.9868)。所提出的检测方法显示出令人满意的分析性能,未来在治疗药物监测领域具有巨大的应用潜力。