A quality control system for ligand-binding assay of plasma renin activity: Proof-of-concept within a pharmacodynamic study

Autor: Fabian Konstantin Suessenbach, Nina Makowski, Martin Feickert, Tanja Gangnus, Jutta Tins, Bjoern Bengt Burckhardt, Stephanie Läer, Jörg Breitkreutz, Ingrid Klingmann, Florian Lagler, Jan de Hoon, Michiel Dalinghaus, Milica Bajcetic, Saskia de Wildt, Anne Keatley Clarke, Johannes Breur, Christoph Male, Laslo Ablonczy, Thomas Mir, Vladislav Vukomanovic, Milan Dukic, Ida Jovanovic, Bjoern B. Burckhardt, Willi Cawello, Karl Kleine, Angelika Moder, Emina Obarcanin, Peter Wagner, Jennifer Walsh, Anne van Hecken, Lucie Spatenkova, Mohsin Ali, Bojana Božić, Maja Bijelić Ilja Burdman, Agnes Ciplea, Muhammad Faisal, Samieh Farahani, Milica Lazic, Fabian Suessenbach, Marijke van der Meulen, Saša Popović, Miro Parezanović, Nori Smeets, Vanessa Swoboda, Dragana Bojanin, Stefan Đorđević, Jasminka Dragić, Ann-Kathrin Holle, Bosiljka Jovičić, Jovan Košutić, Gordana Kozomara, Haidara Majid, Jadranka Mitrović, Sanja Ninić, Miro Parezanovic, Vojislav Parezanovic, Andrija Pavlović, Sergej Prijić, Branislava Rebić, Igor Stefanović, Daniel Tordas, Irena Vulićević, Anke Bartels, Andjelka Čeko, Marissa Herborts, Annelies Hennink, Bosiljka Kosanović, Sanja Kostic, Ljiljana Isailović, Jasmina Maksimovic, Badies Manai, Nada Martinović, Gyöngyi Máté, Miloš Perišić, Jelena Reljić, Regina Pirker Marta Salamomovic, Claudia Schlesner, Eva Wissmann
Rok vydání: 2020
Předmět:
Zdroj: Journal of Pharmaceutical and Biomedical Analysis, 181
ISSN: 0731-7085
Popis: Contains fulltext : 220641.pdf (Publisher’s version ) (Closed access) While the role of plasma renin activity (PRA) in heart failure has been widely studied in adults, comprehensive data on pediatric heart failure remain lacking. This drawback is increasingly being addressed by academic research. Nevertheless, such pediatric investigations are commonly conducted only once due to ethical constraints. Therefore, the quality of bioanalytical data must be ensured to acquire meaningful insights into maturing humoral parameters. However, appropriate post-validation assessment of bioanalytical runs is currently underrepresented by regulatory guidance. Thus, for applications in an academic environment, an easy-to-handle six-step bioanalytical quality control system was designed based on regulatory guidelines (e.g. U.S. Food and Drug Administration) combined with international recommendations (e.g. Clinical and Laboratory Standards Institute) and current scientific discussion. Its applicability to an enzyme-linked immunosorbent assay for determination of PRA was investigated within three pediatric trials of the EU-funded "Labeling of Enalapril in Neonates up to Adolescents" project. This quality control system identified 15 % bioanalytical runs as non-compliant to the predefined specifications and ensured the reliable quantification of 940 pharmacodynamic samples. The inter-run assessment of quality controls was able to demonstrate the comparability of the study results. Furthermore, 86 % of incurred sample reanalysis pairs complied with regulatory requirements (>67 %), thus underlining the long-term reproducibility of the utilized ligand-binding assay. Successful participation in interlaboratory testing confirmed the accuracy of the applied method throughout the entire study period. Further investigations showed no notable differences between the five applied lots of the PRA assay. The applicability of this quality control system was proven in an academic environment and ensured reliable results for PRA over the entire 24-month study period.
Databáze: OpenAIRE
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