TY - JOUR
T1 - A comprehensive quality control system suitable for academic research
T2 - application in a pediatric study
AU - Makowski, Nina
AU - Ciplea, Agnes M
AU - Ali, Mohsin
AU - Burdman, Ilja
AU - Bartel, Anke
AU - Burckhardt, Bjoern B
AU - Breur, JMPJ
N1 - Funding Information:
The authors N Makowski, AM Ciplea, I Burdman and M Ali were financially supported by the European Union Seventh Framework Programme (FP7/2007-2013) under grant agreement n◦602295 (LENA). The author BB Burckhardt was the head of bioanalysis within the LENA project. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. Writing assistance was utilized as the manuscript has been spell-checked by Cambridge Proofreading LLC.
Publisher Copyright:
© 2020 Newlands Press.
PY - 2020/3
Y1 - 2020/3
N2 - Aim:
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.
Methods & results:
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.
Conclusion:
The bioanalytical quality control system successfully monitored the aldosterone assay performance and proved its applicability in the academic environment.
AB - Aim:
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.
Methods & results:
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.
Conclusion:
The bioanalytical quality control system successfully monitored the aldosterone assay performance and proved its applicability in the academic environment.
KW - academic research
KW - aldosterone
KW - incurred sample reanalysis
KW - ligand-binding assay
KW - pediatric clinical trial
KW - quality control system
UR - https://www.scopus.com/pages/publications/85083913707
U2 - 10.4155/bio-2019-0242
DO - 10.4155/bio-2019-0242
M3 - Article
C2 - 32129082
SN - 1757-6180
VL - 12
SP - 319
EP - 333
JO - Bioanalysis
JF - Bioanalysis
IS - 5
ER -