title: 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.
abstract: BACKGROUND
  Pre-acquisition system assessment of clinical laboratory analysers and/or methods are generally repeated independently in each individual organisation planning their introduction. In the course of replacing our 10-year-old Sysmex(®) CA-1500 for Sysmex(®) CS-2100i coagulometers, we designed and tested a model based on CLSI protocols in which one laboratory performs an extensive validation, allowing others to rely on concise verification.
  
  
  METHODS
  Validation of the Sysmex(®) CS-2100i was performed largely according to CLSI Guideline H57-A and included EP-5, 7, 9 and 10 in the evaluation of 10 assays encompassing all measurement principles available. EP-15 was used for end-user verification. Practicability and results of validation and verification were compared.
  
  
  RESULTS
  Analytical performance of the CS-2100i was as claimed by the manufacturer and complied with our own criteria. System verification results were compatible with those of the validation. Verification was time- and cost-effective.
  
  
  CONCLUSIONS
  We have approved the Sysmex(®) CS-2100i analyser for introduction in our laboratory. For colleague laboratories in our region introducing this analyser, a system verification is proposed to be sufficient when referring to our data. It is our intention to use the validation vs. end-user verification model for future method introduction, and when harmonising between our different laboratory locations.
authors.affiliation: Haematological Clinical Chemistry Laboratory, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands.
authors.forename: Pascal J
authors.initials: PJ
authors.lastname: Molenaar
authors.forename: Anja
authors.initials: A
authors.lastname: Leyte
mesh_terms: D016477:Artifacts; D001777:Blood Coagulation; D003362:Cost-Benefit Analysis; D006403:Hematologic Tests / Q000191:economics / Q000295:instrumentation / Q000379:methods*; D006801:Humans; D007202:Indicators and Reagents; D016014:Linear Models; D015203:Reproducibility of Results
chemical_list: D007202:Indicators and Reagents