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CLSI EP09

Measurement Procedure Comparison and Bias Estimation Using Patient Samples

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Organization: CLSI
Publication Date: 1 June 2018
Status: active
Page Count: 116
scope:

This guideline provides recommendations for designing an experiment and selecting methods to quantify systematic measurement error (bias or difference) between measurement procedures based on comparing patient samples. It provides both difference plot and regression procedures to determine the relationship between two measurement procedures either across their measuring intervals or at selected concentrations. Intended users of this guideline are manufacturers of in vitro diagnostic (IVD) reagents-which includes those who create laboratory-developed tests-as well as regulatory authorities and medical laboratory personnel.

This guideline is for use with measurement procedures that provide quantitative numerical results. This guideline is not intended for use with ordinal IVD examinations, commonly referred to as qualitative procedures (see CLSI document EP121). This guideline is not intended to provide information on evaluation of random error (see CLSI documents EP052 and EP153) or to determine the total error inherent in a comparison of measurement procedures (see CLSI document EP214). It is not intended to measure the variability of multiple replicates collected during the measurement of a sample, nor is it intended to measure the bias of individual measurements such as those resulting from sample interference (as covered in CLSI document EP075).

Document History

CLSI EP09
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...
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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