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.
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.
1. Söderberg J, Jonsson PA, Wallin O, Grankvist K, Hultdin J. Haemolysis index – an estimate of preanalytical quality in primary health care. Clin Chem Lab Med 2009;47:940–4.10.1515/CCLM.2009.227Search in Google Scholar
2. Lippi G, Blanckaert N, Bonini P, Green S, Kitchen S, Palicka V, et al. Haemolysis: an overview of the leading cause of unsuitable specimens in clinical laboratories. Clin Chem Lab Med 2008;46:764–72.10.1515/CCLM.2008.170Search in Google Scholar
3. Favaloro EJ, Lippi G, Adcock DM. Preanalytical and postanalytical variables: the leading causes of diagnostic error in hemostasis? Semin Thromb Hemost 2008;34:612–34.10.1055/s-0028-1104540Search in Google Scholar
5. Passing H, Bablok. A new biometrical procedure for testing the equality of measurements from two different analytical methods. Application of linear regression procedures for method comparison studies in clinical chemistry, Part I. J Clin Chem Clin Biochem 1983;21:709–20.Search in Google Scholar
7. Hanneman SK. Design, analysis, and interpretation of method comparison studies. AACN Adv Crit Care 2008;19: 223–34.Search in Google Scholar
9. Richard L. Gorsuch CS. Correlation coefficients: mean bias and confidence interval distortions. J Methods Meas Soc Sci 2010;1:52–65.Search in Google Scholar
11. Salvagno GL, Lippi G, Bassi A, Poli G, Guidi GC. Prevalence and type of pre-analytical problems for inpatients samples in coagulation laboratory. J Eval Clin Pract 2008;14:351–3.10.1111/j.1365-2753.2007.00875.xSearch in Google Scholar PubMed
13. Fischer F, Appert-Flory A, Jambou D, Toulon P. Evaluation of the automated coagulation analyzer Sysmex CA-7000. Thromb Res 2006;117:721–9.10.1016/j.thromres.2005.06.012Search in Google Scholar PubMed
14. Quehenberger P, Kapiotis S, Handler S, Ruzicka K, Speiser W. Evaluation of the automated coagulation analyzer SYSMEX CA 6000. Thromb Res 1999;96:65–71.10.1016/S0049-3848(99)00069-9Search in Google Scholar
15. Appert-Flory A, Fischer F, Jambou D, Toulon P. Evaluation and performance characteristics of the automated coagulation analyzer ACL TOP. Thromb Res 2007;120:733–43.10.1016/j.thromres.2006.12.002Search in Google Scholar PubMed
16. Milos M, Herak DC, Zadro R. Discrepancies between APTT results determined with different evaluation modes on automated coagulation analyzers. Int J Lab Hematol 2010;32:33–9.10.1111/j.1751-553X.2008.01111.xSearch in Google Scholar PubMed
17. Molenaar PJ, Leyte A. Pre-acquisition system assessment of the Sysmex(®) Coagulation System CS-2100i and comparison with end-user verification; a model for the regional introduction of new analysers and methods. Clin Chem Lab Med 2011;49:1479–89.Search in Google Scholar
18. de Bie P, Schornagel WJ, van den Dool EJ, Bakker B, van Dam W, Heckman M, et al. Laboratory evaluation of the Coasys® Plus C coagulation analyzer. Thromb Res 2013;131:357–62.10.1016/j.thromres.2013.02.004Search in Google Scholar PubMed
19. Mullier F, Vanpee D, Jamart J, Dubuc E, Bailly N, Douxfils J, et al. Comparison of five D-dimer reagents and application of an age-adjusted cut-off for the diagnosis of venous thromboembolism in emergency department. Blood Coagul Fibrinolysis 2013 Nov 15. [Epub ahead of print].10.1097/MBC.0000000000000020Search in Google Scholar PubMed
20. Park SJ, Chi HS, Chun SH, Jang S, Park CJ. Evaluation of performance including influence by interfering substances of the innovance D-dimer assay on the Sysmex coagulation analyzer. Ann Clin Lab Sci 2011;41:20–4.Search in Google Scholar
21. Jennings I, Woods TA, Kitchen DP, Kitchen S, Walker ID. Laboratory D-dimer measurement: improved agreement between methods through calibration. Thromb Haemost 2007;98:1127–35.10.1055/s-0037-1613742Search in Google Scholar
22. Milos M, Herak D, Kuric L, Horvat I, Zadro R. Evaluation and performance characteristics of the coagulation system: ACL TOP analyzer – HemosIL reagents. Int J Lab Hematol 2009;31:26–35.10.1111/j.1751-553X.2007.00999.xSearch in Google Scholar
23. Flanders MM, Crist R, Safapour S, Rodgers GM. Evaluation and performance characteristics of the STA-R coagulation analyzer. Clin Chem 2002;48:1622–4.10.1093/clinchem/48.9.1622Search in Google Scholar
©2014 by Walter de Gruyter Berlin/Boston