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CLSI - EP26IG

User Evaluation of Acceptability of a Reagent Lot Change Implementation Guide

active, Most Current
Organization: CLSI
Publication Date: 1 January 2022
Status: active
Page Count: 14

Document History

EP26IG
January 1, 2022
User Evaluation of Acceptability of a Reagent Lot Change Implementation Guide
A description is not available for this item.

References

This document references:
CLSI EP05 - Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline
Published by CLSI on September 1, 2014
This document provides guidance for studies intended to establish the within-site precision performance characteristics of quantitative measurement procedures used in clinical laboratories, and also...
This document references:
CLSI EP09 - Measurement Procedure Comparison and Bias Estimation Using Patient Samples
Published by CLSI on June 1, 2018
This guideline provides recommendations for designing an experiment and selecting methods to quantify systematic measurement error (bias or difference) between measurement procedures based on...
This document references:
EP26 - User Evaluation of Acceptability of a Reagent Lot Change
Published by CLSI on April 1, 2022
This guideline describes a statistically sound protocol for evaluating the consistency of patient sample results when a new analytical reagent lot replaces a reagent lot currently in use. It is...
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