Makowski Nina, Ciplea Agnes M, Ali Mohsin, Burdman Ilja, Bartel Anke, Burckhardt Bjoern B
Institute of Clinical Pharmacy & Pharmacotherapy, Heinrich Heine University, Universitaetsstrasse 1, 40225 Duesseldorf, Germany.
Bioanalysis. 2020 Mar;12(5):319-333. doi: 10.4155/bio-2019-0242. Epub 2020 Mar 4.
Clinical research in pediatrics is progressively initiated by academia. As the reliability of pharmacodynamic measures is closely linked to the quality of bioanalytical data, bioanalytical quality assurance is crucial. However, clear guidance on comprehensive bioanalytical quality monitoring in the academic environment is lacking. By applying regulatory guidelines, international recommendations and scientific discussions, a five-step quality control system for monitoring the bioanalysis of aldosterone by immunoassay was developed. It comprised performance qualification, calibration curve evaluation, analysis of the intra- and inter-run performance via quality control samples, incurred sample reanalysis and external quality assessment by interlaboratory testing. A total of 55 out of 70 runs were qualified for the quantification of aldosterone in the study sample enabling the evaluation of 954 pediatric samples and demonstrating reliability over the 29-month bioanalysis period. The bioanalytical quality control system successfully monitored the aldosterone assay performance and proved its applicability in the academic environment.
儿科学领域的临床研究正逐渐由学术界发起。由于药效学测量的可靠性与生物分析数据的质量密切相关，生物分析质量保证至关重要。然而，在学术环境中，缺乏关于全面生物分析质量监测的明确指导。通过应用监管指南、国际建议和科学讨论，开发了一个五步质量控制系统，用于监测免疫分析法测定醛固酮的生物分析过程。该系统包括性能鉴定、校准曲线评估、通过质量控制样品分析批内和批间性能、对已检测样品进行重新分析以及通过实验室间测试进行外部质量评估。在70次检测中，共有55次合格，能够对研究样本中的醛固酮进行定量分析，从而对954份儿科样本进行评估，并在29个月的生物分析期间证明了其可靠性。生物分析质量控制系统成功地监测了醛固酮检测性能，并证明了其在学术环境中的适用性。
