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A A A xv Q Q Q Q X X X 1 <8 X X X <8 X X X $ $ $ $ $ $ Analytical Evaluation of the automated Galectin-3 assay on the Abbott ARCHITECT immunoassay instruments
David C. Gaze1, Christian Prante2, Jens Dreier2, Cornelius Knabbe2, Corinne Collet3, Jean-Marie Launay3, Janka Franekova4, Antonin Jabor4, Lieselotte Lennartz5, Jessie Shih6, Jose Manuel del Rey7, Martina Zaninotto8, Mario Plebani8, Paul O. Collinson1
1Chemical Pathology, Clinical Blood Sciences, St Georges Healthcare NHS Trust, London, United Kingdom
2Heart and Diabetes Center North Rhine Westfalia, Institute for Laboratory and Transfusion Medicine, Bad Oeynhausen, Germany
3Laboratory of Clinical Biochemistry, Lariboisire Hospital, Paris, France
4Department of Laboratory Methods, Institute for Clinical and Experimental Medicine, Prague, Czech Republic
5 Abbott Laboratories, Wiesbaden, Germany
6 Abbott Laboratories, Abbott Park, IL, US
7Clinical Chemistry, Core Laboratory, Ramon y Cajal Hospital, Madrid, Spain
8Department of Laboratory Medicine, University Hospital of Padova, Italy
Address for Correspondence:
David C. Gaze
Chemical Pathology, Clinical Blood Sciences,
St Georges Healthcare NHS Trust,
Blackshaw Road
London, SW17 0QT
United Kingdom
Tel: +44 (0) 208 725 5878
Fax: +44 (0) 208 725 5868
Email: david.gaze@stgeorges.nhs.uk
Running title: Evaluation of ARCHITECT Galectin-3 Immunoassay
Key Words: Galectin-3, Chronic heart failure, Analytical Performance, ARCHITECT
Non Standard Abbreviations: CHF, chronic heart failure; CLSI, Clinical Laboratory Standards Institute; %CV, coefficient of variation; LoB, Limit of Blank; LoD, Limit of Detection; LoQ, Limit of Quantification; AMR, analytical measurement range.
Acknowledgments: Abbott Laboratories provided the protocol and reagents for this study.
Number of Words: 2710
Number of Figures: 3
Number of Tables: 3
Number of References: 22Abstract
Aim. 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 multi-centred 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).
Materials and methods. We evaluated the assay precision and dilution linearity for both routine and STAT assays and compared serum and plasma and fresh versus 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 Inc.).
Results. The total assay coefficient of variation (CV%) was 2.3-6.2% and 1.7 to 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 ng/mL and 28.4 ng/mL respectively. Values were significantly lower in subjects aged <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.
Introduction
Heart failure is common in Europe, affecting approximately 1-2% of the adult population (1). The incidence and prevalence increases with age with the average age of diagnosis being 76 years ADDIN REFMGR.CITE Cowie199957Incidence and aetiology of heart failure; a population-based studyJournal57Incidence and aetiology of heart failure; a population-based studyCowie,M.R.Wood,D.A.Coats,A.J.Thompson,S.G.Poole-Wilson,P.A.Suresh,V.Sutton,G.C.1999/3AdultAgedAged,80 and overAtrial FibrillationClinical TrialsComparative StudycomplicationsCoronary DiseasediagnosisEchocardiographyElectrocardiographyepidemiologyetiologyFemaleHeartHeart FailureHeart Valve DiseasesHumansHypertensionIncidenceLondonMalemethodsMiddle AgedPopulation SurveillanceReproducibility of ResultsRetrospective StudiesNot in File421428Eur.Heart J.206Cardiac Medicine, Imperial College School of Medicine at the National Heart & Lung Institute, London, UKPM:10213345Eur.Heart J.1(2). The risk of CHF is greater in men than women but there are more women with CHF than men due to population demographics ADDIN REFMGR.CITE Petersen20021024Coronary Heart Disease Statistics: hgeat failure supplementData File1024Coronary Heart Disease Statistics: hgeat failure supplementPetersen,S.Rayner,M.Wolstenhome,J.2002HeartNot in FileLondonBritish Heart Foundation13(1). Prognosis is poor; forty percent of patients die within one year of diagnosis and survival is less than 10% per year thereafter ADDIN REFMGR.CITE Cowie200058Survival of patients with a new diagnosis of heart failure: a population based studyJournal58Survival of patients with a new diagnosis of heart failure: a population based studyCowie,M.R.Wood,D.A.Coats,A.J.Thompson,S.G.Suresh,V.Poole-Wilson,P.A.Sutton,G.C.2000/5AdultAgedAged,80 and overbloodBlood PressureCreatininediagnosisepidemiologyFemaleFollow-Up StudiesHeartHeart FailureHumansLondonMaleMiddle AgedmortalityphysiopathologyPopulation SurveillancePrognosisRespiratory SoundsRiskRisk FactorsSurvival RateNot in File505510Heart835Cardiac Medicine, Imperial College School of Medicine at the National Heart and Lung Institute, London SW3, UK. m.cowie@abdn.ac.ukPM:10768897Heart1