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CLSI EP09

Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline

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Organization: CLSI
Publication Date: 1 July 2010
Status: inactive
Page Count: 78
scope:

Introduction and Scope

This document provides both users and manufacturers of clinical laboratory devices with guidance for designing an experiment to evaluate the bias between two methods that measure the same analyte. Ideally, a test (or candidate) method should be compared with a reference method. For users, the comparative method is often the current routine method, however, and the purpose of the evaluation is to determine if the two methods yield equivalent results within the statistical power of the experiment. In this case, determining whether the test method is a suitable replacement for a current method is the primary concern.

This guideline allows the estimation of the bias (expected difference) between two methods at various concentrations. If the comparative method is the same one used by the manufacturer in the statement of claims, it is possible to compare statistically the experimental results to the manufacturer's claims to verify acceptable performance.

Document History

June 1, 2018
Measurement Procedure Comparison and Bias Estimation Using Patient Samples
This guideline provides recommendations for designing an experiment and selecting methods to quantify systematic measurement error (bias or difference) between measurement procedures based on...
August 1, 2013
Measurement Procedure Comparison and Bias Estimation Using Patient Samples; Approved Guideline
This document provides guidance for designing an experiment and selecting methods to quantify systematic measurement error (bias or difference) between measurement procedures based on comparing...
CLSI EP09
July 1, 2010
Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline
Introduction and Scope This document provides both users and manufacturers of clinical laboratory devices with guidance for designing an experiment to evaluate the bias between two methods that...
September 20, 2002
Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline
Foreword The current literature contains may examples of user and manufacturer product evaluations, with many different experimental and statistical procedures for comparing two methods that measure...
January 1, 1993
Method Comparison and Biasa Estimation Using Patient Samples; Tentative Guideline
A description is not available for this item.

References

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