Magdalena Krintus1, Jon Ardanza Fernandez2, Christine Chesters3, Rossana Colla4, Clare Ford5, Daniele Frattolillo4, Ursula Köller6, Jacques Mairesse7, Daniel Martinez Jimenez2, Jérôme Motol8, Kevin Padmore3, Hayley Sharrod-Cole5, Grazyna Sypniewska1. 1. Department of Laboratory Medicine, Nicolaus Copernicus University, Collegium Medicum, Bydgoszcz, Poland. 2. Department of Biochemistry, Core Laboratory, Hospital Universitario de Álava, Vitoria, Spain. 3. Alder Hey Children's NHS, Liverpool, United Kingdom. 4. Azienda USL di Reggio Emilia, Ospedale di Guastalla U.O. Laboratorio Analisi, Guastalla, Italy. 5. Royal Wolverhampton NHS Trust, Wolverhampton, United Kingdom. 6. Institute for Laboratory Diagnostics, Vienna Hospital Association, Hospital Hietzing, Vienna, Austria. 7. Clinique St Pierre, Ottignies, Belgium. 8. Laboratoire Biopath, Bry sur Marne, France.
Abstract
BACKGROUND: Early access for routine testing with the Alinity c clinical chemistry system (Abbot Laboratories) presented the opportunity to characterize the analytical performance of multiple analytes across clinical laboratories in Europe. METHODS: A total of 8 laboratories from 7 European countries evaluated 10 high-volume chemistry assays on the Alinity c system for imprecision, linearity, and accuracy by method comparison to the routine ARCHITECT (Abbott Laboratories) method. RESULTS: Within-run precision was less than 4% coefficient of variation (CV), with total imprecision less than 5.6% CV for 5- and 20-day evaluations. Linearity met expectations, and method comparison showed strong correlation between the Alinity and ARCHITECT methods, with overall linear correlation coefficient between 0.980 to 1.000 and slopes of the regression line between 0.963 and 1.034. Mean percentage difference between the results of assays run on the ARCHITECT and the Alinity ranged between -1.7% and 2.15%. CONCLUSIONS: Our results demonstrated acceptable key analytical performance across all assays tested at each participating laboratory.
BACKGROUND: Early access for routine testing with the Alinity c clinical chemistry system (Abbot Laboratories) presented the opportunity to characterize the analytical performance of multiple analytes across clinical laboratories in Europe. METHODS: A total of 8 laboratories from 7 European countries evaluated 10 high-volume chemistry assays on the Alinity c system for imprecision, linearity, and accuracy by method comparison to the routine ARCHITECT (Abbott Laboratories) method. RESULTS: Within-run precision was less than 4% coefficient of variation (CV), with total imprecision less than 5.6% CV for 5- and 20-day evaluations. Linearity met expectations, and method comparison showed strong correlation between the Alinity and ARCHITECT methods, with overall linear correlation coefficient between 0.980 to 1.000 and slopes of the regression line between 0.963 and 1.034. Mean percentage difference between the results of assays run on the ARCHITECT and the Alinity ranged between -1.7% and 2.15%. CONCLUSIONS: Our results demonstrated acceptable key analytical performance across all assays tested at each participating laboratory.
Authors: Jong Do Seo; Da Young Song; Youngwon Nam; Chihchiao Li; Seunghwan Kim; Joon Hee Lee; Kyunghoon Lee; Junghan Song; Sang Hoon Song Journal: Pract Lab Med Date: 2020-10-20