A continued method performance monitoring approach for the determination of pediatric renin samples – application within a European clinical trial
| Autor: | S.N. de Wildt, B.B. Burckhardt, Anke Bartel, Mohsin Ali, Nina Makowski, M Feickert, I Burdman |
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| Rok vydání: | 2020 |
| Předmět: |
Quality Control
medicine.medical_specialty Adolescent Test data generation Computer science Clinical Biochemistry Enzyme-Linked Immunosorbent Assay Sample (statistics) 030204 cardiovascular system & hematology 01 natural sciences White People 03 medical and health sciences 0302 clinical medicine Renin medicine Humans Medical physics Child Clinical Trials as Topic 010401 analytical chemistry Biochemistry (medical) Infant Newborn Infant Reproducibility of Results General Medicine Guideline 0104 chemical sciences Clinical trial Child Preschool Performance monitoring Renal disorders Radboud Institute for Health Sciences [Radboudumc 11] |
| Zdroj: | Clinical Chemistry and Laboratory Medicine, 58, 11, pp. 1847-1855 Clinical Chemistry and Laboratory Medicine, 58, 1847-1855 |
| ISSN: | 1437-4331 1434-6621 2019-1162 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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