EP19
A Framework for Using CLSI Documents to Evaluate Clinical Laboratory Measurement Procedures, 2nd ed.
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CLSI’s EP19 is a reference guide for the use of CLSI documents in method evaluations. It's especially accessible and useful to those who are new to CLSI documents, as EP19 introduces and explains helpful statistical concepts that are used in other CLSI evaluation protocol documents. EP19 also introduces the measurement procedure lifecycle concept that's used in other CLSI evaluation protocol documents.
EP19 is useful for clinical laboratories that modify commercial measurement procedures to create a new measurement procedure, as these labs are required to establish acceptable performance through analytical validation and clinical validation, and then reverify performance as part of implementation.
This document is organized around the measurement procedure lifecycle paradigm, which follows the concept that all measurement procedures undergo an initial establishment phase performed by manufacturers, followed by implementation in laboratories. Logically organized in a step-by-step manner, this guideline describe the considerations and requirements for measurement procedure evaluations including planning and the selection of appropriate CLSI documents and other related documents for validation, verification, and other evaluations. EP19 is intended for:
- Clinical laboratory professionals
- Manufacturers
- Governmental agencies
