title: Validation of the Sysmex CS5100 coagulation analyzer and comparison to the Stago STA-R analyzer for routine coagulation parameters.
abstract: BACKGROUND
  The CS5100 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 - DDi) assays.
  
  
  METHODS
  A comparison with the currently used STA-R Evolution (Stago) was performed. Validation and verification of reference values of the CS5100 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.
  
  
  CONCLUSIONS
  In conclusion, the CS5100 instrument is suitable for the determination of the APTT, PT, FBG, DDi and AT in routine analysis.
authors.affiliation: Laboratory of Hematology, University Hospital of Antwerp, Edegem, Belgium.
authors.forename: T
authors.initials: T
authors.lastname: Geens
authors.forename: F
authors.initials: F
authors.lastname: Vertessen
authors.forename: R
authors.initials: R
authors.lastname: Malfait
authors.forename: K
authors.initials: K
authors.lastname: Deiteren
authors.forename: M B
authors.initials: MB
authors.lastname: Maes
mesh_terms: D001780:Blood Coagulation Tests / Q000295:instrumentation* / Q000379:methods* / Q000592:standards; D006801:Humans; D012016:Reference Values; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
keywords: Stago STA-R; Sysmex CS5100; factor sensitivity; reference interval; unfractionated heparin range