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Analytical evaluation of the automated galectin-3 assay on the Abbott ARCHITECT immunoassay instruments.

Gaze, DC; Prante, C; Dreier, J; Knabbe, C; Collet, C; Launay, J-M; Franekova, J; Jabor, A; Lennartz, L; Shih, J; et al. Gaze, DC; Prante, C; Dreier, J; Knabbe, C; Collet, C; Launay, J-M; Franekova, J; Jabor, A; Lennartz, L; Shih, J; del Rey, JM; Zaninotto, M; Plebani, M; Collinson, PO (2014) Analytical evaluation of the automated galectin-3 assay on the Abbott ARCHITECT immunoassay instruments. Clin Chem Lab Med, 52 (6). pp. 919-926. ISSN 1437-4331 https://doi.org/10.1515/cclm-2013-0942
SGUL Authors: Collinson, Paul

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Abstract

BACKGROUND: Galectin-3 is secreted from macrophages and binds and activates fibroblasts forming collagen. Tissue fibrosis is central to the progression of chronic heart failure (CHF). We performed a European multicentered evaluation of the analytical performance of the two-step routine and Short Turn-Around-Time (STAT) galectin-3 immunoassay on the ARCHITECT i1000SR, i2000SR, and i4000SR (Abbott Laboratories). METHODS: We evaluated the assay precision and dilution linearity for both routine and STAT assays and compared serum and plasma, and fresh vs. frozen samples. The reference interval and biological variability were also assessed. Measurable samples were compared between ARCHITECT instruments and between the routine and STAT assays and also to a galectin-3 ELISA (BG Medicine). RESULTS: The total assay coefficient of variation (CV%) was 2.3%-6.2% and 1.7%-7.4% for the routine and STAT assays, respectively. Both assays demonstrated linearity up to 120 ng/mL. Galectin-3 concentrations were higher in plasma samples than in serum samples and correlated well between fresh and frozen samples (R=0.997), between the routine and STAT assays, between the ARCHITECT i1000 and i2000 instruments and with the galectin-3 ELISA. The reference interval on 627 apparently healthy individuals (53% male) yielded upper 95th and 97.5th percentiles of 25.2 and 28.4 ng/mL, respectively. Values were significantly lower in subjects younger than 50 years. CONCLUSIONS: The galectin-3 routine and STAT assays on the Abbott ARCHITECT instruments demonstrated good analytical performance. Further clinical studies are required to demonstrate the diagnostic and prognostic potential of this novel marker in patients with CHF.

Item Type: Article
Additional Information: This is the accepted manuscript version of an article published in final form at https://doi.org/10.1515/cclm-2013-0942
Keywords: Automation, Blood Chemical Analysis, Enzyme-Linked Immunosorbent Assay, Galectin 3, Humans, Limit of Detection, Male, Middle Aged, Reference Values, Time Factors, Humans, Galectin 3, Blood Chemical Analysis, Enzyme-Linked Immunosorbent Assay, Time Factors, Reference Values, Automation, Middle Aged, Male, Limit of Detection, analytical performance, ARCHITECT, chronic heart failure, galectin-3, Science & Technology, Life Sciences & Biomedicine, Medical Laboratory Technology, MEDICAL LABORATORY TECHNOLOGY, analytical performance, ARCHITECT, chronic heart failure, galectin-3, HEART-FAILURE, PERFORMANCE-CHARACTERISTICS, BIOLOGICAL VARIATION, POPULATION, FIBROSIS, INFLAMMATION, MACROPHAGES, DYSFUNCTION, ACTIVATION, DIAGNOSIS, General Clinical Medicine, 1103 Clinical Sciences, 1702 Cognitive Science
SGUL Research Institute / Research Centre: Academic Structure > Molecular and Clinical Sciences Research Institute (MCS)
Academic Structure > Molecular and Clinical Sciences Research Institute (MCS) > Cardiac (INCCCA)
Journal or Publication Title: Clin Chem Lab Med
ISSN: 1437-4331
Language: eng
Dates:
DateEvent
1 June 2014Published
16 January 2014Published Online
4 December 2013Accepted
Publisher License: Publisher's own licence
PubMed ID: 24445238
Web of Science ID: WOS:000337154600027
Go to PubMed abstract
URI: https://openaccess.sgul.ac.uk/id/eprint/108975
Publisher's version: https://doi.org/10.1515/cclm-2013-0942

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