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Validation of the Sysmex CS 5100 coagulation analyzer and comparison to the Stago STA ‐R analyzer for routine coagulation parameters
Author(s) -
Geens T.,
Vertessen F.,
Malfait R.,
Deiteren K.,
Maes M.B.
Publication year - 2015
Publication title -
international journal of laboratory hematology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.705
H-Index - 55
eISSN - 1751-553X
pISSN - 1751-5521
DOI - 10.1111/ijlh.12295
Subject(s) - partial thromboplastin time , prothrombin time , fibrinogen , coagulation , spectrum analyzer , chromogenic , chromatography , antithrombin , reference range , medicine , chemistry , surgery , computer science , heparin , telecommunications
Summary Introduction The CS 5100 analyzer (Sysmex) was validated for the determination of routine coagulation parameters. This fully automated coagulation analyzer uses multiple wavelength technology to perform coagulation (e.g., activated partial thromboplastin time – APTT , prothrombin time – PT , fibrinogen – FBG ), chromogenic (e.g., antithrombin – AT ) and immunological (e.g., D‐dimers – DD i) assays. Methods A comparison with the currently used STA ‐R Evolution (Stago) was performed. Validation and verification of reference values of the CS 5100 was performed in accordance to CLSI guidelines (H57‐A, H47‐A2, and C28‐A3). Results As a different detection system and reagents were used, significant differences were observed (e.g. APTT ). The within‐day and between‐day imprecision, accuracy and total error were all acceptable. The reference values defined by the manufacturer could be used except for APTT . In our settings, the therapeutic anti‐Xa range of 0.3–0.7 IU /mL corresponded to an APTT range of 60–100 s (Dade actin FS reagent). The APTT reagent showed factor sensitivities between 46 and 72% for FVIII , IX , XI and XII while the PT reagent showed sensitivities between 34 and 52% for FII , FV , FXII , and FX . Conclusion In conclusion, the CS 5100 instrument is suitable for the determination of the APTT , PT , FBG , DD i and AT in routine analysis.