New Guideline Approved for Evaluation of Between-Reagent-Lot Variation

The Clinical and Laboratory Standards Institute (CLSI; Wayne, PA, USA) has now published “EP26-A—User Evaluation of Between-Reagent Lot Variation; Approved Guideline,” a document that provides guidance on evaluation of new analytical reagent lots. EP26-A provides laboratory users with a protocol to evaluate the consistency of patient sample results compared to the reagent lot currently in use. It uses patient samples to help users detect significant changes in MPP due to reagent lot changes and to confirm-before-use that patient sample results are consistent between the two lots. Also, although this guideline is intended for the clinical laboratory and does not provide detailed procedures for reagent manufacturers, reagent manufacturers can use this document to understand the types of verification studies that may be performed in their customers’ laboratories.

“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 (NJ, 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.”

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Clinical and Laboratory Standards Institute