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Licensed Unlicensed Requires Authentication Published by De Gruyter April 10, 2014

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

Franz Ratzinger, Klaus G. Schmetterer, Helmuth Haslacher, Thomas Perkmann, Sabine Belik and Peter Quehenberger


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.

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:


We are grateful that Siemens provide required reagents for measuring on the CS-5100.

Conflict of interest statement

Authors’ conflict of interest disclosure: The authors stated that there are no conflicts of interest regarding the publication of this article. Research support played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.

Research funding: None declared.

Employment or leadership: None declared.

Honorarium: None declared.


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Received: 2013-12-18
Accepted: 2014-3-13
Published Online: 2014-4-10
Published in Print: 2014-8-1

©2014 by Walter de Gruyter Berlin/Boston

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