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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 / Payne, Deborah A. / Schlattmann, Peter / Tate, Jillian R.

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IMPACT FACTOR 2016: 3.432

CiteScore 2016: 2.21

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1437-4331
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Volume 52, Issue 8 (Aug 2014)

Issues

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 / Peter Quehenberger
Published Online: 2014-04-10 | DOI: https://doi.org/10.1515/cclm-2013-1094

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.

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

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

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About the article

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:


Received: 2013-12-18

Accepted: 2014-03-13

Published Online: 2014-04-10

Published in Print: 2014-08-01


Citation Information: Clinical Chemistry and Laboratory Medicine (CCLM), ISSN (Online) 1437-4331, ISSN (Print) 1434-6621, DOI: https://doi.org/10.1515/cclm-2013-1094.

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