Preliminary Evaluation of Quantitative Clinical Laboratory Measurement Procedures; Approved Guideline
|Publication Date:||1 November 2006|
Before starting a complete evaluation of a new measurement procedure, kit, or instrument for in vitro diagnostic use, it is often necessary to make a preliminary decision about its acceptability. This initial performance check is neither a rigorous investigation into the procedure's long-term performance, nor an evaluation of the many factors that can affect results produced by the device. The primary purpose of this document is to help detect problems that are severe enough to warrant immediate correction, referral to the manufacturer, or expanded investigation. Accreditation bodies may have requirements for verification or validation that exceed the procedures in this document (see CLSI document EP151).
Manufacturers can also benefit by performing this protocol either as assays are developed or when they are validated. By performing more than five runs, manufacturers can detect trends in the effects estimated by EP10 or document their absence.