New CLSI Method Evaluation Guideline - Reagent Lot Variation

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.

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

Source: CLSI
Image credits: MediaDiagnostici

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