Analytical Performance of 10 High-Volume Clinical Chemistry Assays on the Alinity c System

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 c...

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Published inLaboratory medicine Vol. 50; no. 1; pp. e1 - e8
Main Authors Krintus, Magdalena, Fernandez, Jon Ardanza, Chesters, Christine, Colla, Rossana, Ford, Clare, Frattolillo, Daniele, Köller, Ursula, Mairesse, Jacques, Jimenez, Daniel Martinez, Motol, Jérôme, Padmore, Kevin, Sharrod-Cole, Hayley, Sypniewska, Grazyna
Format Journal Article
LanguageEnglish
Published US Oxford University Press 01.02.2019
Subjects
Architects
Biochemical assays
Biomedical laboratories
Blood Chemical Analysis - instrumentation
Blood Chemical Analysis - standards
Clinical chemistry
Equipment and supplies
Laboratories
Pharmaceutical industry
Product information
United States
imprecision
analytical performance
method comparison
linearity
Alinity
clinical chemistry
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Summary: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.
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ISSN:0007-5027
1943-7730
DOI:10.1093/labmed/lmy053