Feickert Martin, Burdman Ilja, Makowski Nina, Ali Mohsin, Bartel Anke, Burckhardt Bjoern B
Institute of Clinical Pharmacy and Pharmacotherapy, Heinrich Heine University, Dusseldorf, Germany.
Clin Chem Lab Med. 2020 Oct 25;58(11):1847-1855. doi: 10.1515/cclm-2019-1162.
Background Plasma renin levels were determined in the academia-driven, EU-funded "Labeling of Enalapril from Neonates up to Adolescents" (LENA) project to evaluate its role in pediatric heart failure. Quality-controlled bioanalysis is crucial to ensure reliable data generation. However, a comprehensive bioanalytical quality control (QC) concept to monitor the method performance within an academic environment was lacking. Methods Thus, a QC concept was designed encompassing regulatory guidance, international recommendations and current scientific discussions. The concept included (1) a system-suitability test, (2) verification of single bioanalytical runs by calibration curve performance and evaluation of QCs, (3) assessment of the inter-run accuracy according to Clinical Laboratory Standards Institute (CLSI) guideline, (4) monitoring of reproducibility by pediatric incurred samples, (5) blank-sample analysis and (6) participation in interlaboratory testing. Results The concept was successfully applied to the academic project. About 11% of single runs were identified as invalid and triggered a re-analysis of unknown samples being included in those runs. The usefulness of the customized inter-run monitoring was demonstrated and proved the good accuracy from the first to the last run. All 147 reanalyzed incurred sample pairs complied with regulatory requirements. Conclusions The regulatory complied QC concept was customized for the demands of academia-driven pediatric trials and contributed to the reliable quantification of 965 pediatric renin samples.
在由学术界推动、欧盟资助的“依那普利从新生儿到青少年的标签”（LENA）项目中测定了血浆肾素水平，以评估其在小儿心力衰竭中的作用。质量控制的生物分析对于确保生成可靠数据至关重要。然而，缺乏一个全面的生物分析质量控制（QC）概念来监测学术环境中的方法性能。方法：因此，设计了一个QC概念，涵盖监管指南、国际建议和当前的科学讨论。该概念包括：（1）系统适用性测试；（2）通过校准曲线性能和QC评估来验证单次生物分析运行；（3）根据临床实验室标准协会（CLSI）指南评估批间准确性；（4）通过儿科实际样本监测重现性；（5）空白样本分析；（6）参与实验室间测试。结果：该概念成功应用于该学术项目。约11%的单次运行被判定无效，并触发了对包含在这些运行中的未知样本的重新分析。定制的批间监测的实用性得到了证明，并证明了从第一次运行到最后一次运行的良好准确性。所有147对重新分析的实际样本均符合监管要求。结论：符合监管要求的QC概念是针对学术界推动的儿科试验的需求定制的，有助于对965份儿科肾素样本进行可靠定量。
