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Validated low-volume aldosterone immunoassay tailored to GCLP-compliant investigations in small sample volumes

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...

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Autores principales: Schaefer, J., Burckhardt, B.B., Tins, J., Bartel, A., Laeer, S.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5633836/
https://www.ncbi.nlm.nih.gov/pubmed/29034304
http://dx.doi.org/10.1016/j.plabm.2017.07.004
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author Schaefer, J.
Burckhardt, B.B.
Tins, J.
Bartel, A.
Laeer, S.
author_facet Schaefer, J.
Burckhardt, B.B.
Tins, J.
Bartel, A.
Laeer, S.
author_sort Schaefer, J.
collection PubMed
description 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 European Medicines Agency (EMA) and U.S. Food and Drug Administration (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 of 40 μL, it is especially valuable for pediatric investigations.
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spelling pubmed-56338362017-10-13 Validated low-volume aldosterone immunoassay tailored to GCLP-compliant investigations in small sample volumes Schaefer, J. Burckhardt, B.B. Tins, J. Bartel, A. Laeer, S. Pract Lab Med Article 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 European Medicines Agency (EMA) and U.S. Food and Drug Administration (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 of 40 μL, it is especially valuable for pediatric investigations. Elsevier 2017-07-27 /pmc/articles/PMC5633836/ /pubmed/29034304 http://dx.doi.org/10.1016/j.plabm.2017.07.004 Text en © 2017 The Authors http://creativecommons.org/licenses/by-nc-nd/4.0/ This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
spellingShingle Article
Schaefer, J.
Burckhardt, B.B.
Tins, J.
Bartel, A.
Laeer, S.
Validated low-volume aldosterone immunoassay tailored to GCLP-compliant investigations in small sample volumes
title Validated low-volume aldosterone immunoassay tailored to GCLP-compliant investigations in small sample volumes
title_full Validated low-volume aldosterone immunoassay tailored to GCLP-compliant investigations in small sample volumes
title_fullStr Validated low-volume aldosterone immunoassay tailored to GCLP-compliant investigations in small sample volumes
title_full_unstemmed Validated low-volume aldosterone immunoassay tailored to GCLP-compliant investigations in small sample volumes
title_short Validated low-volume aldosterone immunoassay tailored to GCLP-compliant investigations in small sample volumes
title_sort validated low-volume aldosterone immunoassay tailored to gclp-compliant investigations in small sample volumes
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5633836/
https://www.ncbi.nlm.nih.gov/pubmed/29034304
http://dx.doi.org/10.1016/j.plabm.2017.07.004
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