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CLSI EP09

Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline

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Organization: CLSI
Publication Date: 20 September 2002
Status: inactive
scope:

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 the same analyte. This methodologic variety has caused confusion, and users have reported that comparisons often lack sufficient data and description to be reproducible.

There has also been an increasing awareness that the scope of evaluation procedures appropriate for manufacturers of diagnostic devices is not always appropriate for their users. The manufacturer is concerned with establishing valid and achievable performance claims for bias when compared with a generally accepted standard or reference method. The user might wish to compare a candidate method with a different one than the manufacturer used in establishing the bias claims. The scope of the experimental and data-handling procedures for these two purposes can often differ.

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...
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...
CLSI EP09
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.
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