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- Title
Pre-acquisition system assessment of the Sysmex<sup>®</sup> Coagulation System CS-2100 i and comparison with end-user verification; a model for the regional introduction of new analysers and methods.
- Authors
Molenaar, Pascal J.; Leyte, Anja
- 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-2100 i 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-2100 i 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-2100 i 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-2100 i 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.
- Subjects
BLOOD coagulation; EVALUATION; LABORATORY equipment &; supplies; HARMONIC analyzers; LABORATORY techniques; PERFORMANCE technology; EQUIPMENT &; supplies
- Publication
Clinical Chemistry & Laboratory Medicine, 2011, Vol 49, Issue 9, p1479
- ISSN
1434-6621
- Publication type
Article
- DOI
10.1515/CCLM.2011.615