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

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. 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. 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. 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.