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Clinical Chemistry and Laboratory Medicine (CCLM)

Published in Association with the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM)

Editor-in-Chief: Plebani, Mario

Ed. by Gillery, Philippe / Lackner, Karl J. / Lippi, Giuseppe / Melichar, Bohuslav / Schlattmann, Peter / Tate, Jillian R. / Tsongalis, Gregory J.


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Evaluation of the automated coagulation analyzer CS-5100 and its utility in high throughput laboratories

Franz Ratzinger1 / Klaus G. Schmetterer1 / Helmuth Haslacher1 / Thomas Perkmann1 / Sabine Belik1 / 1

1Department of Laboratory Medicine, Medical University of Vienna, Vienna, Austria

Corresponding author: Peter Quehenberger, Department of Laboratory Medicine, Medical University of Vienna, Waehringer Guertel 18-20, 1090 Vienna, Austria, Phone: +43 1 40400 5383, Fax: +43 1 40400 5392, E-mail:

Citation Information: Clinical Chemistry and Laboratory Medicine (CCLM). Volume 52, Issue 8, Pages 1193–1202, ISSN (Online) 1437-4331, ISSN (Print) 1434-6621, DOI: 10.1515/cclm-2013-1094, April 2014

Publication History

Received:
2013-12-18
Accepted:
2014-03-13
Published Online:
2014-04-10

This article offers supplementary material which is provided at the end of the article.

Abstract

Background: Automated analyzers are an important component of modern laboratories. As a representative of the newest generation of coagulation analyzers, the CS-5100 features several technical refinements including a pre-analytical assessment unit as well as multi-wavelength optical detection units. Therefore, the CS-5100 is supposed to rapidly and accurately perform a broad panel of coagulation tests. In the current study, the CS-5100 was evaluated regarding its precision and practicability in a clinical laboratory setting.

Methods: The CS-5100 was evaluated regarding its intra- and inter-assay precision using commercially available control samples. Results of patient samples, including hemolytic, icteric and lipemic specimens, measured on the CS-5100 were compared to reference analyzers, which are used in our accredited laboratory.

Results: The coefficients of variation, assessed in the intra- and inter-assay precision analyses were below 5% representatively for most parameters. Results, obtained by the CS-5100 showed predominantly a high comparability to used reference analyzers, with correlation coefficients ranging from 0.857 to 0.990. Only minor ranged systemic or proportional differences were found in Passing-Bablok regression between the CS-5100 and reference analyzers regarding most of the tested parameters. Lipemic samples had a tendency to deteriorate correlation coefficients, but an overall effect of the sample’s triglyceride level could be ruled out. In a routine setting, the analyzer reached a sample throughput rate of 160 tests per hour.

Conclusions: The CS-5100 is able to rapidly and precisely measure patient samples. No considerable influence on test comparability was found for elevated levels of free hemoglobin, bilirubin or triglycerides.

Keywords: analyzer comparison; Bland-Altman plot; coefficient of variation; CS-5100; partial correlation coefficient; Passing-Bablok regression

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