Monday, October 21, 2013

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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1 comment:

  1. Where on earth has CLSI posted this document? I've been searching everywhere. It seems the only option is to purchase a $170.00 book published by Siemens. Is CLSI becoming a self perpetuating regulatory and money making operation to justify their jobs?

    I agree that reagent comparison is an important issue and would love some guidance on it. This seems to be a scheme to make money!

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