Evaluation of Analysis Methods and Interferences of SYSMEX CN-6000 and STAGO STA-R Coagulation Analyzers
Abstract
Abstract
Objective: The aim of this study was to compare the analytical methods of STAGO STA-R and SYSMEX CN-6000 coagulation analyzers. Also, to evaluate the effects of lipemia and hemolysis interferences on the methods. STA-R detects clotting using an electromechanical method, while the CN-6000 detects clotting using an optical method. We compared the activated partial thromboplastin time (APTT), prothrombin time (PT), Fibrinogen (FBG) and D-Dimer results of both analyzers. We also examined the effects of hemolysis and lipemia on PT (INR), APTT and FBG analyses.
Methods: Randomly selected blood samples from Gaziantep University Hospital patients were used. PT (INR), APTT, FBG, D-Dimer analysis was performed using both analyzers. Precision, comparability and interference studies were performed in the study. Studies were performed according to CLSI documents (H21-A5, EP15-A3, EP07-Ed3)
Results: In the precision study, all % CV values were within the acceptable limits of between-subject biologic variation criteria for hemostasis tests. The correlation coefficients of PT (INR), APTT, FBG, D-Dimer results between the two devices were found to be r=0.982 (p<0,01) ,r=0.872 (p<0,01), r=0.945 (p<0,01) and r=0.981 (p<0,01) respectively. In the hemolysis and lipemia interference study, the results were within the limits recommended by Fraser.
Discussion: Differences between results in the study may be due to differences in the reagents and methods used. Interferences for both analyzers were assessed to be within the targets recommended by Fraser, but the CN-6000 was found to be unable to perform on highly lipemic samples.
Keywords: Blood Coagulation Tests, Hemolysis, Lipemia, Interference, SYSMEX CN-6000, STAGO STA-R.
References
2. Lippi G, Adcock D, Simundic AM, Tripodi A, Favaloro EJ. Critical laboratory values in hemostasis: toward consensus. Annals of medicine. 2017;49(6):455-61.
3. Fischer F, Appert-Flory A, Jambou D, Toulon P. Evaluation of the automated coagulation analyzer Sysmex CA-7000. Thromb Res. 2006;117(6):721-9.
4. Nguyen G, Lejeune M, Gaaloul M, Martin-Toutain I, Delorme JP, Bourti Y, et al. Performance evaluation of the fully automated random-access multiparameter Sysmex CN-6000 hemostasis analyzer at a core laboratory with a high sample throughput. International journal of laboratory hematology. 2022;44(2):385-92.
5. CLSI H21-A5 Collection, Transport, and Processing of Blood Specimens for Testing PlasmaBased Coagulation Assays and Molecular Hemostasis Assays; Approved Guideline—Fifth Edition. Clinical and Laboratory Standards Institute ; 2008.
6. Kitchen S, Adcock DM, Dauer R, Kristoffersen AH, Lippi G, Mackie I, et al. International Council for Standardization in Haematology (ICSH) recommendations for processing of blood samples for coagulation testing. International journal of laboratory hematology. 2021;43(6):1272-83.
7. Geens T, Vertessen F, Malfait R, Deiteren K, Maes MB. Validation of the Sysmex CS5100 coagulation analyzer and comparison to the Stago STA-R analyzer for routine coagulation parameters. International journal of laboratory hematology. 2015;37(3):372-81.
8. CLSI EP15-A3 User Verification of Precision and Estimation of Bias, 3rd Edition.Clinical & Laboratory Standards Institute; 2015.
9. CLSI EP07 Interference Testing in Clinical Chemistry, 3rd Edition.Clinical and Laboratory Standards Institute; 2018
10. Negrini D, Bernardi D, Antonelli G, Plebani M. Interference of lipemia in samples for routine coagulation testing using a Sysmex CS-5100 coagulometer. International journal of laboratory hematology. 2019;41(6):772-7.
11. Cupaiolo R, Govaerts D, Blauwaert M, Cauchie P. Performance evaluation of a new Stago(®) automated haemostasis analyser: The STA R Max(®) 2. International journal of laboratory hematology. 2019;41(6):731-7.
12. Florin L, Oyaert M, Van Maerken T, Devreese KMJ. Performance of the preanalytical check module of the Stago STA R Max2 mechanical endpoint detection analyzer for assessing the impact of hemolysis, lipemia, and icterus on aPTT and PT. International journal of laboratory hematology. 2018;40(6):e109-e12.
13. Woolley A, Golmard JL, Kitchen S. Effects of haemolysis, icterus and lipaemia on coagulation tests as performed on Stago STA-Compact-Max analyser. International journal of laboratory hematology. 2016;38(4):375-88.
14. Fraser CG. Test result variation and the quality of evidence-based clinical guidelines. Clinica chimica acta; international journal of clinical chemistry. 2004;346(1):19-24.
15. Desirable Biological Variation Database specifications [updated 2014. Available from: https://www.westgard.com/biodatabase1.htm.
16. CLSI H47 One-Stage Prothrombin Time (PT) Test and Activated Partial Thromboplastin Time (APTT) Test. 3rd ed. Clinical and Laboratory Standards Institute; 2023.
17. Kim H, Jo SY, Kim IS. Performance evaluation of the Sysmex CN-6000-automated coagulation analyzers for routine coagulation tests. Blood coagulation & fibrinolysis : an international journal in haemostasis and thrombosis. 2023;34(2):93-8.
18. Gardiner C, Lane P, Langley K, Tailor H, Machin SJ, Mackie IJ. A comparative evaluation of the CN-6000 haemostasis analyser using coagulation, amidolytic, immuno-turbidometric and light transmission aggregometry assays. International journal of laboratory hematology. 2020;42(5):643-9.
Copyright (c) 2025 seren orhan, Elif işbilen
This work is licensed under a Creative Commons Attribution 4.0 International License.
The published articles will be distributed under the Creative Commons Attribution 4.0 International License (CC BY). It is allowed to copy and redistribute the material in any medium or format, and remix, transform, and build upon it for any purpose, even commercially, as long as appropriate credit is given to the original author(s), a link to the license is provided and it is indicated if changes were made. Users are required to provide full bibliographic description of the original publication (authors, article title, journal title, volume, issue, pages), as well as its DOI code. In electronic publishing, users are also required to link the content with both the original article published in Journal of Medical Biochemistry and the licence used.
Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgement of its initial publication in this journal.