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CLSI Published a New Method Evaluation Guideline: EP26-A—User Evaluation of Between-Reagent Lot Variation

Wayne, Pennsylvania, USA—October 2013—The Clinical and Laboratory Standards Institute (CLSI) has published a new document, EP26-A—User Evaluation of Between-Reagent Lot Variation; Approved Guideline. In a laboratory setting, changes in measurement procedure performance may occur with a change in reagent lot. Therefore, it is a good laboratory practice to verify the consistency of patient sample results when introducing a new lot of reagents. This document provides guidance for laboratories on evaluation of a new reagent lot, including a protocol using patient samples to detect significant changes from the current lot.

EP26-A provides users with a protocol to evaluate the consistency of patient sample results when a new analytical reagent lot replaces a reagent lot currently in use. It also helps users detect significant changes in measurement procedure performance for patient samples due to reagent lot changes, and confirms that patient sample results are consistent between two reagent lots.

“Verifying the performance of a new reagent lot is a common task in the laboratory. Since the need to verify a new lot can occur at any time, on any day, and often needs to be accomplished on short notice, the protocol used must be simple and quick,” notes Nils Person, PhD, FACB, document Chairholder of the EP26-A Document Development Committee and Senior Clinical Consultant at Siemens Healthcare Diagnostics Inc. in Flanders, New Jersey, USA. “To date, there has not been standardized guidance on how best to approach this task. EP26-A provides the needed guidance to verify the performance of a new reagent lot within the practical constraints of the clinical laboratory.”

This guideline is intended for the clinical laboratory environment. It does not provide detailed procedures for reagent manufacturers; however, reagent manufacturers can use this document to understand the types of verification studies that may be performed in their customers’ laboratories.

CLSI is a not-for-profit membership organization that brings together the varied perspectives and expertise of the worldwide laboratory community for the advancement of a common cause: to foster excellence in laboratory medicine by developing and implementing clinical laboratory standards and guidelines that help laboratories fulfill their responsibilities with efficiency, effectiveness, and global applicability. For additional information, visit the CLSI website at or call 610.688.0100.



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