Analytical Evaluation of the Clinical Chemistry Analyzer AU 480 Beckman Coulter
European Journal of Clinical and Biomedical Sciences
Volume 2, Issue 6, December 2016, Pages: 59-62
Received: Oct. 12, 2016;
Accepted: Nov. 8, 2016;
Published: Dec. 10, 2016
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Nardos Abebe, Bethzatha Advanced Medical Laboratory, Quality Assurance Department, Addis Ababa, Ethiopia
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Background: Method verification is a one-time process to determine performance characteristics before a test system is utilized for patient testing. Objective: To evaluate the analytical performance of five analytes-glucose (glu), cholesterol (chol), creatinine (crea), aspartate aminotransferase, (AST) and alanine aminotransferase (ALT) on AU 480 Beckman Coulter clinical chemistry analyzer. Methods and Materials: Analytical evaluation of analyzer included the determination of within-run, within-laboratory imprecision, and Trueness. Beckman Coulter control level-one and control level-two, near medical decision points were used. It was done according to (CLSI) clinical laboratory standard institute (EP15-A2), which suggests two levels, run 3 times per run for 5 days (15replicates in all). Result: The results showed low within-run imprecision (level 1-ALT=1.5%, AST=1.3%, chol=0.5%, crea=0.2%, glu=0.7%, level 2- ALT=1.0%, AST=1.3%, chol=0.6%, crea=0.9%, glu=0.4%) and within-laboratory imprecision (level 1-ALT=2.6%, AST=0.9%, chol=0.7%, crea=0.2%, glu=0.8%, level 2- ALT=1.9%, AST=1.0%, chol=0.6%, crea=0.8%, glu=0.5%)and the assigned values were found to be within trueness verification intervals (level 1 at 95% CI: ALT=46.5U/L[22.7-66.6], AST=50.4U/L[29.1-76.5], chol=156mg/dl[107.1-197.1], crea=1.19mg/dl [0.96-2.03], glu=103mg/dl [69.8-136.3]) and (level 2 at 95% CI: ALT=133U/L [60.5-187.3], AST=148U/L [81.3-220.3], chol=285mg/dl [186.2-349.8], crea=5.35mg/dl [3.46-8.3], glu=239mg/dl [163-320.5]). Conclusion: AU 480 Beckman Coulter clinical chemistry analyzer is suitable for analytical measurement of analytes-AST, ALT, cholesterol, creatinine, and glucose. If laboratories use CLSI and other guidelines, which are published on issues of biological variations, in addition to the manufacturer’s claims, it may help laboratories not to waste unnecessary time and money for repeating of experiment.
AU 480 Beckman Coulter, Trueness, Within-Run Imprecision, Within-Laboratory Imprecision
To cite this article
Analytical Evaluation of the Clinical Chemistry Analyzer AU 480 Beckman Coulter, European Journal of Clinical and Biomedical Sciences.
Vol. 2, No. 6,
2016, pp. 59-62.
Copyright © 2016 Authors retain the copyright of this article.
This article is an open access article distributed under the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/
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Forsman Rodney S. The Value of the Laboratory Professional in the Continuum of Care. Clinical leadership and management review, 370-373. Nov/Dec 2002.
Juricek, J, L. Derek, A. Unic, T. Serdar, D. Marijancevic, M. Zivkovic and Z. Romic. Analytical evaluation of the clinical chemistry analyzer Olympus AU2700 plus. Biocehmia Medica, 2010; 20(3): 334-340.
Muser, J, J. Bienvenu, N. Blanckaert, I. Brandslund, J. Delattre, G. Soffiati, R. Swaminathan, S. Maggini, H. Mastall. Inter-Laboratory evaluation of the Cobas Integra 400 analytical system. Clin Chem. Lab. Med, 2001; 39(6): 539-559.
Miler, M, A. M. Simundic, M. Stefanovic, D. FerenecRuzic, M. Kvaternik, E. Topic and N. Vrkic, A model for results comparison on two different biochemistry analyzers in laboratory accredited according to the ISO 15189. BiochemiaMedica,2009; 19: 287-293.
ISO 15189: 2012. Medical laboratories. Requirements for quality and competence. International organization for standardization, Geneva, 2012.
ES ISO 15189:2013. Medical laboratories. Requirements for quality and competence. Ethiopian Standard Agency, Addis Ababa. 2007.
CLSI. User Verification of Performance for Precision and Trueness; Approved Guideline-Second Edition. CLSI document EP15-A2. Clinical and Laboratory Standards Institute, Pennsylvania, 2005.
The Westgard Web Lessons. Avaliable at: http://www.westgard.com/lesson.htm. Accessed January 5, 2016.
Ricos C, Perich C, Minchinela J, Alvarez V, Simon M, Biosca C, et al. Application of biological variation - a review. Biochem Med 2009; 19:250-9.
Ricos C, Alvarez V, Cava F, Garcia-Lario JV, Hernandez A, Jimenez CV, et al. Current databases on biologic variation: pros, cons and progress. Scand J Clin Lab Invest 1999; 59: 491-500. This database was most recently updated in 2014.