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Validated low-volume aldosterone immunoassay tailored to GCLP-compliant investigations in small sample volumes
J Schaefer1, B B Burckhardt1, J Tins1
1Institute of Clinical Pharmacy and Pharmacotherapy, Heinrich-Heine-University Duesseldorf, Universitaetsstrasse 1, 40225 Duesseldorf, Germany.
Introduction:
Heart failure is well investigated in adults, but data in children is lacking. To overcome this shortage of reliable data, appropriate bioanalytical assays are required.
Objectives:
Development and validation of a bioanalytical assay for the determination of aldosterone concentrations in small sample volumes applicable to clinical studies under Good Clinical Laboratory Practice.
Methods:
An immunoassay was developed based on a commercially available enzyme-linked immunosorbent assay and validated according to current bioanalytical guidelines of the EMA and FDA.
Results:
The assay (range 31.3-1000 pg/mL [86.9-2775 pmol/L]) is characterized by a between-run accuracy from - 3.8% to - 0.8% and a between-run imprecision ranging from 4.9% to 8.9% (coefficient of variation). For within-run accuracy, the relative error was between - 11.1% and + 9.0%, while within-run imprecision ranged from 1.2% to 11.8% (CV). For parallelism and dilutional linearity, the relative error of back-calculated concentrations varied from - 14.1% to + 8.4% and from - 7.4% to + 10.5%, respectively.
Conclusions:
The immunoassay is compliant with the bioanalytical guidelines of the EMA and FDA and allows accurate and precise aldosterone determinations. As the assay can run low-volume samples, it is especially valuable for pediatric investigations.
