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Title: Performance characteristics of automated clinical chemistry analyzers using commercial assay reagents contributing to quality assurance and clinical decision in a hospital laboratory
Authors: Tzortzopoulos, Athanasios 
Raftopoulos, Vasilios 
Talias, Michael A. 
Major Field of Science: Medical and Health Sciences
Field Category: Clinical Medicine
Keywords: Clinical chemistry;Clinical decision;Evaluation;Sigma metrics;Uncertainty;Validation studies
Issue Date: 2-Jan-2020
Source: Scandinavian Journal of Clinical and Laboratory Investigation, 2020, vol. 80, no. 1, pp. 46-54
Volume: 80
Issue: 1
Start page: 46
End page: 54
Journal: Scandinavian Journal of Clinical and Laboratory Investigation 
Abstract: Background: Clinical laboratories provide essential diagnostic services that are essential in clinical decision making, contributing to the quality of healthcare. The performance of two Siemens ADVIA 1800 analyzers was characterized in a hospital Biochemistry laboratory in order to evaluate the analytical characteristics of such automated analyzer systems using nonoriginal assay reagents attempting to support laboratory quality service and crucial clinical decision making. Methods: We independently completed performance validation studies including trueness, precision, sensitivity as well as measurement of uncertainty and sigma metrics calculation for 25 biochemical parameters. Results: Trueness expressed as bias was less than 20% for both ADVIA 1800 analyzers. Within run and total precisions expressed as CV% were ≤9.85% on both analyzers for most parameters studied with few exceptions (Mg, TB, DB, Cl, HDL and UA) observed either in low or in high level samples and between the two analyzers. LoB, LoD and LoQ values produced by the two analyzers were comparable except Cl. Uncertainty values produced by the two analyzers were comparable with no significant differences. Quality performance of reagent assays was studied using the sigma metrics system. The sigma values were plotted on normalized method decision charts for graphical representation of assay performances for each analyzer. Conclusions: The two ADVIA systems, independently evaluated, showed consistent performance characteristics with certain discrepancies by several reagents. Sigma analysis was helpful for revealing the quality performance of non-original reagents supporting the need for strict assessment of quality assurance and in some instances optimization/improvement of assay methods.
ISSN: 1502-7686
DOI: 10.1080/00365513.2019.1695282
Rights: © Medisinsk Fysiologisk Forenings Forlag (MFFF)
Type: Article
Affiliation : Cyprus University of Technology 
General Hospital of Agrinio 
Aghia Sophia Children's Hospital 
Open University Cyprus 
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